Regulatory Specialist Resume Sample

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Burnice Mayer
7198 Cale Station,  Philadelphia, PA
+1 (555) 446 1503

Work Experience

Regulatory Specialist
02/2016 - PRESENT
Boston, MA
  • Experience of implementing and advising on regulatory/compliance programmes would be beneficial
  • An understanding and knowledge of Irish Banking Prudential regulation would be highly desirable
  • Support business with FSQR initiatives, projects, licensing and certifications
  • Develop, implement and maintain programs, processes and documentation related to regulatory affairs and compliance for GEOS-NA. Uses in-depth knowledge of regulatory affairs to provide consultation on regulatory topics
  • As one of the department’s regulatory experts, the incumbent is required to provide guidance to assure that all regulatory submissions are planned, communicated and executed per regulatory and business requirements
  • Conduct trainings and/or communicate appropriate materials, as needed, in order to enhance team’s knowledge of working in a regulated environment
  • Works with research departments and trial sponsor to establish process and timelines for clinical trial activation
Senior Regulatory Specialist
07/2011 - 12/2015
Phoenix, AZ
  • Represents department in all sponsor audits, educating monitors and sponsors on SMO processes and procedures, evaluates monitoring visit response letters and facilitates timely responses to all audits
  • Participates in interview process to select new team members. Trains new staff on department processes, updates and new procedures. Updates department training manual
  • SSU Centralized Regulatory Hub Support - Performs assigned activities within the SSU Centralized Hub that support SSU activities as needed, from Site Start up to Close out, in all phases of clinical trials related to investigational drugs, biologicals and medical devices as required
  • Local Site ID and Feasibility Support - Works with site selection lead and PM/SSUL to ensure that the appropriate sites are selected for individual studies based on the requirements of the clinical trial. Produces site-specific contracts from country template. Submits proposed contract and budget for site.
  • Interface with corporate functional partners on a regular basis to ensure Global Business Unit regulatory compliance
  • Support new acquisions and or subsidiaries and develop tools working with Corporate functional groups to provide support on regulatory/quality matters as needed
  • Respond to customer inquiries regarding regulatory matters
Environmental Regulatory Specialist
04/2005 - 03/2011
Philadelphia, PA
  • Assist with writing and management of requlatory documents and certifications relevant to the business segment
  • Work with our IT department and other support groups to implement processes for execution and management of electronic drug master files eDMF
  • Assist in review and processing of Quality Agreements
  • Collect, review and analyze quality metrics received from legacy plants and acquisitons
  • Prepare for and support communications and meetings related to regulatory compliance
  • Responsible and accountable for on-time submission and accuracy of regulatory reports
  • Knowledge of and familiarity with global regulations for reporting


Wittenberg University
2000 - 2004
Bachelor's Degree in Chemistry

Professional Skills

  • Proficient to advanced computer skills; proactive strong organizational skills. Excellent verbal and written interpersonal skills
  • Proven interpersonal skills including ability to work well in a team environment, as well as excellent written and oral communication skills
  • Strong people management skills and superior communication skills with a proven track record of achievement at a senior level
  • Demonstrated effective problem solving, strong time management skills and the ability to prioritize multiple tasks are also required
  • Strong skills in PC based documentation tools including MS Office and MS Project with Project Management skills
  • Strong math skills and attention to detail with independent analytical and problem-solving skills
  • Strong communication and interpersonal skills; German or French language skills an asset

How to write Regulatory Specialist Resume

Regulatory Specialist role is responsible for interpersonal, computer, organizational, analytical, technical, regulatory, microsoft, organization, word, english.
To write great resume for regulatory specialist job, your resume must include:

  • Your contact information
  • Work experience
  • Education
  • Skill listing

Contact Information For Regulatory Specialist Resume

The section contact information is important in your regulatory specialist resume. The recruiter has to be able to contact you ASAP if they like to offer you the job. This is why you need to provide your:

  • First and last name
  • Email
  • Telephone number

Work Experience in Your Regulatory Specialist Resume

The section work experience is an essential part of your regulatory specialist resume. It’s the one thing the recruiter really cares about and pays the most attention to.
This section, however, is not just a list of your previous regulatory specialist responsibilities. It's meant to present you as a wholesome candidate by showcasing your relevant accomplishments and should be tailored specifically to the particular regulatory specialist position you're applying to. The work experience section should be the detailed summary of your latest 3 or 4 positions. Representative Regulatory Specialist resume experience can include:

  • The Customer Quality Clinician provides guidance to complaint handling specialist regarding investigation of product related events reported worldwide from patients, customers, sales reps and clinical studies/registries in order to assess product relationship to reported complaint
  • The Customer Quality Clinician assesses customer complaints for potential regulatory reporting, based on product specific criteria. He /she verifies assessments of regulatory reporting requirements are accurate and in accordance with regulatory guidelines and product labeling
  • Developed project management skills including the use of Microsoft Project, Good Presentation and organization skills
  • Computer Skills – Excellent computer skills including but not limited to Microsoft Office
  • Strong inter-personal skills and an ability to effectively communicate complex ideas and concepts to a diverse audience
  • Strong leadership skills and experience in interacting with knowledgeable and demanding audiences at all levels of management

Education on a Regulatory Specialist Resume

Make sure to make education a priority on your regulatory specialist resume. If you’ve been working for a few years and have a few solid positions to show, put your education after your regulatory specialist experience. For example, if you have a Ph.D in Neuroscience and a Master's in the same sphere, just list your Ph.D. Besides the doctorate, Master’s degrees go next, followed by Bachelor’s and finally, Associate’s degree.

Additional details to include:

  • School you graduated from
  • Major/ minor
  • Year of graduation
  • Location of school
These are the four additional pieces of information you should mention when listing your education on your resume.

Professional Skills in Regulatory Specialist Resume

When listing skills on your regulatory specialist resume, remember always to be honest about your level of ability. Include the Skills section after experience. Present the most important skills in your resume, there's a list of typical regulatory specialist skills:

  • Proven management experience and skills, excellent written and verbal communication skills, and keen analytical skills
  • Good communication and presentation skills; Good project management experience and problem solving skills in the cross-functional role
  • Excellent organizational skills including time management and ability to effectively prioritize multiple projects
  • Strong analytical and problem solving skills, excellent interpersonal and communications skills, highly organized and ability to act as a role model for staff
  • Excellent project management skills with the ability to effectively prioritize
  • Excellent communication skills, both verbal and written, and excellent interpersonal skills

List of Typical Experience For a Regulatory Specialist Resume


Experience For Senior Regulatory Specialist Resume

  • Good oral and written communications skills, analytical thinking and technical writing; ability to work on cross-functional teams
  • Assist in identifying data needed, obtaining these data and ensuring that they are effectively presented for the registration of products worldwide
  • Experience defining problems, apply solutions and verify the effectiveness of the solutions at preventing reoccurrence of the problems
  • Prior monitoring/auditing experience
  • Effectively communicating with the supervisor in the event of a denial for further action
  • Possess technical writing and verbal skills
  • Providing excellent service, accurate information, and specific guidance to internal and external customers regarding licensure functions

Experience For Associate Regulatory Specialist Resume

  • Skilled in interpreting data to ensure that the Food Safety and Food Quality expectations are being accomplished according to established procedures
  • Experience working with regulators and participating in production facility audits
  • Experience in managing projects and achieving results through teams of professional individual contributors, consultants, and associated support staff
  • Experience with regulatory processes and standards, including document standards and electronic document management systems (EDMS)
  • Experiences in Mobile telecommunication regulatory issues such as interconnect, frequency, pricing and licenses
  • Demonstrated flexibility and adaptability to quickly changing goals and directions
  • Help in the archiving of information necessary for product validation and customer claim substantiation

Experience For Environmental Regulatory Specialist Resume

  • Demonstrate expertise with the Globally Harmonized System for Classification and Labeling of Chemicals (GHS)
  • Resolves routine, non-routine and complex problems by applying extensive technical knowledge and experience
  • Prioritizes work per needs of department to support regulatory reporting and complaint investigation timeliness
  • Works with appropriate functional departments to achieve effective corrective action on severe and/or recurring problems
  • Solid understanding of relevant chemistry and/or analytics is required
  • Demonstrates understanding of functionality/intended use of complex in vitro diagnostic laboratory medical devices and their application in clinical practice

Experience For Compliance & Regulatory Specialist Resume

  • Work closely with the Protocol compliance team to ensure all documents are ready prior to a study opening
  • Produce and maintain a regulatory binder prior to study starting with all required documents
  • Corresponding and communicating with applicants regarding omissions or deficiencies in license applications
  • Working knowledge of Health Agency regulations for the assigned region and industry standards pertaining to regulatory operations
  • Playing active role in developing the mobile telecom regulatory environment
  • Suggesting strategic modifications regarding policy areas that principally affect mobile telecommunications

Experience For Customer Quality Regulatory Specialist Resume

  • Providing support and analysis of key legislative developments affecting mobile services
  • Understanding of guidelines and regulations around technical submission requirements for assigned region and/or deliverables
  • Working with department management, communicates with US FDA, EU Notified Bodies, EU Competent Authorities and other international regulatory authorities
  • Reviewing the incumbent regulatory policies and give advice
  • Reviewing the incumbent activities and guarantee it is consistent with competition rules

Experience For Product Regulatory Specialist Resume

  • Following up any anticompetitive complaints with the regulator
  • Reviewing applications for licenses, permits, and registrations to ensure the applicants, premises, and locations are qualified for licensure
  • Processing routine and complex applications based upon department policy, Florida Administrative Code, or Florida Statutes
  • Preparing reports and other documentation to provide information to the division, department, licensees, and the public
  • Assisting other members of the Finance team and completing ad-hoc tasks as requested
  • Assists with compliance training initiatives including coordinating educational sessions, writing and editing compliance manuals, and developing presentations
  • Develop proficiency in interpreting, communicating and implementing FAA, FCC and NEPA guidelines: review documents for compliance with guidelines
  • Business Continuity, Outsourcing, Nearshoring & Offshoring and Vendor management

Experience For Regulatory Specialist, Food Colors Resume

  • Responsible for monitoring updates to HA regulations related to dossier formatting/assembly and assessing the impact on the business process
  • Is capable of shaping the pipeline for new regulations in regulatory demand planning and contribute to the development of our Regulatory Target Operating Model
  • Assure protocols have complete, consistent language throughout, including proper SAE reporting requirements, coordinating center requirements, etc
  • Assists in the review of product labeling/advertising to ensure compliance with federal regulations
  • Accomplished in searching and interpreting regulatory and technical information
  • Provide training to appropriate business partners to ensure understanding of FCC compliance requirements as necessary
  • Support COO, Operations, IT, Fund Accounting and LCD in preparing regulatory reports
  • Ensure efficiency of data accuracy by conducting audits on complaints and establishing process improvements to prevent recurrences
  • Is strategic in positioning and directly defining our position and action plan with our internal stakeholders and partners

Experience For Research Regulatory Specialist Resume

  • Can manage internal communication by way of briefings and training on upcoming key regulations and their impact to internal stakeholders
  • Proactively identifying issues and suggesting appropriate strategies to mitigate risks
  • Review external communication material and device labeling, including quote text, for regulatory compliance
  • Take personal responsibility for personal growth, driving team collaboration, and finding new, improved, and simpler ways to work
  • Maintain current knowledge base of existing and emerging regulations, standards, or guidance documents
  • Supports regulatory planning for new product introductions and product changes, and assist in maintaining regulatory compliance
  • Lead initiatives directed at creating and executing expansion and improvement of departmental policies and procedures
  • Attend study start up meeting for studies where SKCCC is the coordinating center

Experience For Principal Regulatory Specialist Resume

  • Perform regulatory screening on all NJ Projects and advise team on scope required to get approval, i.e. minor/mod, full filing, section 106 review
  • Directly interface with Hospitals, Surgeons, and Internal employees for reporting of complaints and adverse events
  • Adhere and comply to work instructions, standard operating procedures, and regulations
  • Expedite investigations by collaborating with internal/external business partners
  • Fully training within three months of hire
  • Regulatory conditions in Myanmar are conducive to a favourable operating environment
  • Execute regulatory tasks and play a consultative role by partnering across business functions
  • Develop and maintain relationships with regulatory personnel representing those carriers and clients with whom Crown has business dealings

Experience For Clinical Trials Regulatory Specialist Resume

  • Research regulatory compliance inquiries as required, including review and analysis of acquisition due diligence and in response to alleged violations
  • Proficient in word processing and database applications
  • Knowledge of Data Safety Monitoring Board (DSMB) operations
  • Assists with the monthly reporting of data for established metrics
  • Remains current with all assigned training
  • Data gathering and analysis of Hedge Fund, CLO and Commodity Pool securities inventory for inclusion in Regulatory reports
  • Work thoroughly with AM Data Management team and/or 3rd Party Vendor on the automation of reporting requirements
  • Prepares 510(k) Decision Trees as required to support engineering change orders

List of Typical Skills For a Regulatory Specialist Resume


Skills For Senior Regulatory Specialist Resume

  • Communicate effectively with others, including proficiency in written and verbal communications, and strong listening skills
  • Expert clinical practice, leadership skills, and critical thinking skills
  • Good understanding of data management, experience in accreditation processes, quality improvement methodology, and facilitation skills
  • Collaboration: a strong influencer with excellent negotiation skills and the ability communicate at al levels
  • Strong attention to detail and good record-keeping skills
  • Excellent organizational, prioritization and follow up skills. Ability to handle multiple tasks / projects simultaneously
  • Very good computer skills (work experience with complex computer systems or databases would be an advantage)
  • Strong Project Management skills required and experience with SAP, Oracle PLMs, Agile, Windchill is desirable
  • Outstanding active listening skills and strong collaboration among key business contacts

Skills For Associate Regulatory Specialist Resume

  • Effectively reading and interpreting information, accurately presenting numerical data, and skillfully gathering and analyzing information
  • Excellent problem solving, critical thinking, and decision making skills is required. Ability to conduct root cause analysis is required
  • Demonstrated computer skills including spreadsheets, word processing, e-mail, database, internet research and other applicable software programs
  • Experience in working effectively with cross-functional teams; especially with manufacturing sites
  • Analytical and self-reliant working manner as well as excellent problem solving skills
  • Effective problem solving and decision-making skills and behavioral capability to develop commercially viable customer solutions

Skills For Environmental Regulatory Specialist Resume

  • Work in a team environment including excellent communication skills
  • Strong time management and organizational skills – attentive to deadlines and able to manage multiple projects and competing demands simultaneously
  • Excellent communication skills including fluent written and spoken English, with any other languages as an advantage
  • Demonstrated problem-solving skills and the ability to impartially resolve disputes
  • Excellent communication & convincing skills

Skills For Compliance & Regulatory Specialist Resume

  • Computer software applications including knowledge of MS Office (strong Excel skills desired), Documentum, SAP
  • Strong computer related skills (Microsoft suite including Excel, and Word),
  • Good communication and writing skills in Japanese and English
  • Excellent composition and drafting skills, with emphasis on various compliance/regulatory documents and correspondence
  • Strong computer related skills (including Microsoft Office)
  • Good communication, negotiation and writing skills
  • Good planning and organization skills are required

Skills For Customer Quality Regulatory Specialist Resume

  • Excellent computer skills including MS Word, Adobe, and Excel
  • Demonstrated ability to communicate and collaborate effectively within an internationally working team
  • Strong time management, organized, able to handle a multitude of responsibilities at the same time, detail oriented, technical writing skills required
  • Strong analytical skills to be able to review large amounts of data and compare to existing policies and procedures
  • Strong time management, organizational and multi-tasking skills is required
  • Excellent analytical problem-solving skills is required
  • Demonstrated Technical writing skills required
  • Strong PC / internet skills including Microsoft Office Suite

Skills For Product Regulatory Specialist Resume

  • Good record-keeping skills
  • Excellent communication skills (written & verbal); Fluent in English
  • Good problem-solving skills and accuracy/attention to detail
  • Excellent analytical capability, written and verbal communication skills
  • Strong leadership skills to lead projects, to stand up to "do the right thing", to drive change and influence cross-functional partners
  • Effective verbal / written communication, interpersonal, and influencing skills

Skills For Regulatory Specialist, Food Colors Resume

  • Good negotiation skills, diplomacy and professional judgement are required
  • Good computer skills, with the flexibility to learn web technology, DevEX, JDE ERP systems, and document control computer systems
  • Team-player with strong interpersonal and customer service skills
  • Excellent English verbal and written communication skills across functions
  • Good interpersonal skills, integrity, and professionalism
  • Excellent verbal, interpersonal, and written communication skills in both local and English language
  • Strong PC skills in all Microsoft office applications,

Skills For Research Regulatory Specialist Resume

  • Strong oral and written communication skills, as well as the ability to provide scientific presentations
  • Good interpersonal/communication skills are essential
  • Outstanding customer service, time management, problem solving, and interpersonal skills
  • Writing and verbal communication skills
  • Prior experience compiling and submitting an FDA 510(k) submission is required
  • Computer skills: MS Word, PowerPoint, MS Project, Adobe Acrobat, Excel, database, graphics presentation applications, document processing/publishing tools
  • Critical information seeking and problem solving skills
  • Prior experience of interpreting and applying prudential regulation rules and guidance

Skills For Principal Regulatory Specialist Resume

  • Prior experience of preparing prudential returns (FSA/COREP), investment firm ICAAP and financial modelling
  • Effectively challenges others’ ideas or opinions without creating hostility
  • Strong knowledge of regulatory affairs, including FDA regulations, IRB review and approval process, and Good Clinical Practice
  • Experience working in Regulatory & Medical Affairs function in Consumer goods
  • Experience in consumer goods including MD is welcome

Skills For Clinical Trials Regulatory Specialist Resume

  • Demonstrates a strong personal capacity for learning new aspects of the business and encourage others to do the same
  • Prior experience working with the RRC, BLM, NMOCD, and NMSLO
  • One year in an effective work-related field, including clinical trials or health care experience required
  • Previous experience in clinical research including submissions experience
  • Proven track record / successful experience in working with national and/or local government agencies such as CDC, NHFPC, CFSA, FDA, AQSIQ etc
  • Self-motivated with good communication skill and team spirit; willing to work under pressure
  • Regulatory affairs experience ideally including experience in regulatory submissions with FDA/EU requirements
  • Previous experience managing multiple priorities
  • Fluency in English (spoken and written) and preferably having some skills in a further language

List of Typical Responsibilities For a Regulatory Specialist Resume


Responsibilities For Senior Regulatory Specialist Resume

  • Development and management of a comprehensive risk governance and oversight program, maintained in the company’s Governance Risk and Compliance system, Archer
  • Partner with Risk Management to develop, prepare and present periodic risk reports to senior management and the Board, including expansion of reporting to include subsidiaries
  • Oversee the monitoring of the likelihood of risk events occurring and respond to risk events, providing post event analysis and mitigation recommendations to appropriate members of leadership
  • Prior supervisory experience as well as strong coaching and mentoring skills an advantage
  • Serve internal and external customers and demonstrate good customer relations skills
  • Good organizational skills and an ability to manage multiple tasks/projects/priorities and complex systems simultaneously are needed
  • A strong legal or compliance background and proven experience in financial markets with ideally direct experience within the Asset Management sector
  • Strong attention to detailStrong project management skills is required

Responsibilities For Associate Regulatory Specialist Resume

  • Advanced presentation and public speaking skills with previous experience facilitating public discussions
  • Excellent planning, time management, problem-solving and analytical skills; and
  • Good interpersonal skills and interest in working and interacting with diverse cultures
  • Good listening, conflict management and negotiation skills
  • Strong organizational, time management, interpersonal, listening, conflict management and negotiation skills

Responsibilities For Environmental Regulatory Specialist Resume

  • Strong leadership skills to represent Global Stewardship in commercialization projects and to stand up to "do the right thing"
  • Strong communication, presentation and computer and data base knowledge skills are required
  • Good interpersonal and verbal/written communication skills are needed
  • Good record retention and customer service skills
  • Clear evidence of results orientation and project coordination / management skills

Responsibilities For Compliance & Regulatory Specialist Resume

  • Excellent communication (written and oral), interpersonal and organizational skills
  • Strong analytical skills required along with the ability to analyze technical documents
  • Strong computer skills (SAP, MS Office Suite)
  • Strong project management skillset and drive for execution
  • Excellent written & oral communication & team coordination skills

Responsibilities For Customer Quality Regulatory Specialist Resume

  • Strong organizational, interpersonal and communication skills to plan and accomplish goals
  • Proven ability to effectively influence site and global personnel
  • Excellent analytical skills, ability to analyze data and components of legislation, policies and procedures based upon regulatory requirements
  • Excellent written and verbal communication skills and ability to present information in a clear and concise manner
  • Excellent written & oral communication & project management skills
  • Strong MS Office software skills
  • Excellent written and verbal communication skills, with the ability to collaborate and influence at all levels of the organization

Responsibilities For Product Regulatory Specialist Resume

  • Excellent written skills and the ability to succinctly convey information to senior management and other stakeholders
  • Excellent communication, organizational, verbal, and written skills required
  • Good and persuasive presentation and writing skills and the ability to represent the company
  • Demonstrated leadership skills is required
  • Develop good project management skills to ensure progress is communicated and deadlines are met

Responsibilities For Regulatory Specialist, Food Colors Resume

  • Good communication skills at all levels (written and verbal)
  • For non-native English speakers: possess excellent skills in written and spoken English (for international projects)
  • Proven customer service skills with the ability to tactfully work with all levels of personnel are necessary
  • Strong verbal & grammar skills
  • Strong skills in computers, spreadsheets, and databases required
  • Strong written and verbal skills are important
  • Strong analytical problem solving skills required
  • Strong decision-making and customer service skills to offer options and resolve problems

Responsibilities For Research Regulatory Specialist Resume

  • Prior experience dealing with federal APDs on federal land
  • Well-developed cooperation and communication skills, including cross-departmental relationships
  • Experience or equivalent combination of education and experience in preparing global regulatory strategies for medical devices
  • Basic computer skills – Keyboarding, Word, data entry
  • Independently apply skills to successfully identify and resolve moderately complex problems not covered by existing procedures or practices
  • Technical writing skills and ability to review and summarize data into clearly written reports
  • Fluent in English (spoken and written) and preferably having some skills in a further language

Responsibilities For Principal Regulatory Specialist Resume

  • Prior relevant clinical research experience in biotechnology, pharmaceutical, CRO or other health care setting
  • Problem solving/Root cause analysis skills are required
  • Research experience which includes at least one (1) year of experience working in an academic research or related environment
  • Previous experience in clinical research including submissions experience and site contract negotation
  • Demonstrated ability to work within and operate in a corporate environment
  • Effectively present information and respond to audience inquires
  • Communicate effectively and efficiently both verbally and written
  • Active listening/phone skills

Responsibilities For Clinical Trials Regulatory Specialist Resume

  • Demonstrate strong ability to respond quickly to new opportunities
  • Demonstrate model behavior that understands what the priorities are and encourages others to drive for results
  • Review and interpret scientific literature and summarize effectively in writing
  • Demonstrated experience with ArcGIS highly desirable
  • Task management experience with strong attention to detail
  • Well-developed oral and written communication skills, ability to translate complex ideas into clear and simple format
  • HS- with advanced level of experience/ BS or MS with minimal level of experience

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