Regulatory Affairs Resume Sample

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Ian Flatley
990 Josh Green,  Boston,  MA
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Work Experience


Regulatory Affairs Director
02/2018 - PRESENT
New York, NY
  • Connect by encouraging and supporting internal collaboration across levels, creating effective solutions. Builds and leverages internal and external networks with colleagues, cross-functional partners, and industry contacts to identify opportunities and open communication channels
  • Shape by challenging the status quo and adapting to change, taking advantage of opportunities to have a positive impact. Engages with regulatory agencies, industry groups, standards committees, political/government agencies, in order to influence external stakeholders and promote Regulatory perspectives
  • Lead by leveraging diverse perspectives and backgrounds to generate effective ideas or solutions
  • Deliver by acting with speed, flexibility , accountability and appropriately managing priorities to deliver results for on-time clearances
  • In depth knowledge of quality system requirements such as ISO 13485 and FDA’s 21 CFR Part 820
  • Proofing information against copy, marking errors, and checking for accuracy
  • Proofing WORD document versions of labeling
  • Ensuring new labeling and labeling revisions are prepared according to department guidances
  • Assuring labeling projects are processed completely and efficiently
Regulatory Affairs
08/2014 - 11/2017
Phoenix, AZ
  • Develop and maintain relationships with external partners and health care regulatory authorities
  • Self-motivated, critical thinker and problem solver, with the ability to lead by example, an enthusiastic, optimistic outlook, and a collaborative style
  • Demonstrated ability to motivate and manage multiple levels of personnel. Skilled at identifying and developing personnel
  • Strategic leadership and thinking to ensure compliance is delivered cost effectively
  • Think creatively in confronting new issues and pursuing novel approaches to old problems
  • Remains calm under adverse conditions, and reaches independent, reasoned solutions by thinking in a clear, decisive manner
  • Read, analyze and interpret business periodicals, common scientific, professional and technical journals, governmental regulations and legal documents
  • Extensive knowledge of pharmaceutical packaging regulations and quality control systems
  • Work under pressure, meet deadlines and exercise sound business judgment with critical thinking skills and high ethical standards
Product Regulatory Affairs Intern
05/2009 - 05/2014
Chicago, IL
  • Ensuring proofing activities are properly recorded
  • Resolving queries directly with the project coordinator and/or graphic artist
  • Ensuring that illustrations/tables/graphs are correctly captioned and referred to in the body of text
  • Using a style checklist to ensure consistency in hyphenation, capitalization, formatting, etc
  • Performing various support functions for the department
  • Be passionate about regulatory affairs leadership in support of the production of state-of-the art implantable medical devices
  • Work by influencing peers and their reports and gain their cooperation in dealing with multiple priorities in the management of compliance

Education


Amberton University
2004 - 2008
Bachelor's Degree in Science

Professional Skills


  • Strong interpersonal skills incl. negotiation skills and significant experience in interacting with regulatory authorities
  • Leadership skills (problem solver, ability to deal with multiple priorities, strong interpersonal skills, sound judgement and attentive to details)
  • Strong leadership skills with influencing and consulting skills, Act with Integrity,
  • Strong attention to detail, ability to multi-task and demonstrate strong writing and communication skills
  • Excellent communication skills, analytical skills and planning ability
  • Relevant clinical experience in various levels of patient care. Strong planning, organizing, decision making, analytical, and problem solving skills
  • Highly effective communication skills, both oral and written (including evidence of writing reports/briefings) and people skills

How to write Regulatory Affairs Resume

Regulatory Affairs role is responsible for interpersonal, organizational, regulatory, english, negotiation, leadership, presentation, computer, analytical, business.
To write great resume for regulatory affairs job, your resume must include:

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

Contact Information For Regulatory Affairs Resume

The section contact information is important in your regulatory affairs 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 Affairs Resume

The section work experience is an essential part of your regulatory affairs 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 affairs 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 affairs position you're applying to. The work experience section should be the detailed summary of your latest 3 or 4 positions.

Representative Regulatory Affairs resume experience can include:

  • Previous experience in attending and/or helping a team prepare for a Major Health Authority interactions (e.g. FDA advisory committee meetings, Oral explanations, Scientific Advice, Pre-NDA/BLA, EOP2 meetings etc.)
  • >5 years experience or equivalent of regulatory drug development including product approval/launch. Expert knowledge of regulatory affairs within one or more therapeutic areas
  • Strong oral and written communication skills as well as strong organizational skills
  • Strong analytical and written and oral communication skills. Solid scientific skills
  • Excellent organization, project management skills, ability to multitask and to work effectively in multidisciplinary and multicultural teams
  • Writing skills that can be effectively communicated to technical and non-technical internal and external stakeholders

Education on a Regulatory Affairs Resume

Make sure to make education a priority on your regulatory affairs resume. If you’ve been working for a few years and have a few solid positions to show, put your education after your regulatory affairs 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 Affairs Resume

When listing skills on your regulatory affairs 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 affairs skills:

  • Solid verbal and written communication and technical writing skills; effective group speaking and presentation skills
  • Good communication skills (both oral and written) as well as good organizational and planning skills
  • Demonstrated strong attention to detail; excellent time management skills and proven ability to meet tight deadlines and ability to work under pressure
  • Excellent oral and written technical communication skills, strong interpersonal skills, and superior organizational abilities
  • Strong interpersonal skills and the ability to deal effectively with a variety of personnel, including medical and scientific staff
  • Excellent written and oral communication skills, including confident presentation skills

List of Typical Experience For a Regulatory Affairs Resume

1

Experience For Regulatory Affairs Director Resume

  • Excellent writing and verbal communication skills and experience working on cross-functional project teams and new product development systems
  • Develop and execute complex plans with strong priority setting skills
  • Excellent organization and project management skills with the ability to prioritize and balance multiple tasks with minimal supervision
  • + Strong interpersonal and negotiation/influencing skills while maintaining a high level of professionalism
  • Demonstrated problem solving skills including situations that include ambiguity
2

Experience For Director of Regulatory Affairs Resume

  • Proven experience to manage stakeholders using an analytical approach and excellent communication
  • Excellent English scientific writing skills
  • + Demonstrated technical writing skills
  • Possess strong presentation and negotiation skills as well as the ability to influence/change the thinking or gain acceptance of others in sensitive situations
  • Works effectively with Human Resources in all aspects of talent management (Recruiting, training, assessments and development)
  • Manage several competing priorities; versatility, flexibility, and willingness to work with changing priorities
3

Experience For Specialist, Regulatory Affairs Resume

  • Proven experience with developing robust global clinical and regulatory strategies supporting the commercialization of high risk permanent implantable devices
  • Prior experience authoring and negotiating IDE, 510(k), Technical Files and Design Dossiers
  • Regulatory affairs experience in a pharmaceutical or biotech company, including senior management experience
  • Demonstrated experience and proficiency with MS Office word processing, spreadsheet,
  • Some years of experience working in a clinical research role OR some years progressive experience with clinical research
4

Experience For Senior Specialist, Regulatory Affairs Resume

  • GCP (Good Clinical Practice) training and experience in clinical trials research
  • Effectively communicates impending regulatory changes, business impacts, and compliance strategies to key stakeholders
  • Experience in building effective teams
  • Demonstrated experience interfacing with regulatory agencies (e.g. FDA, ANVISA, Health Canada, CFDA, etc.) and standards bodies such as AAMI, IEC, ISO, UL
  • Computer skills, E-mail (Lotus Notes), Microsoft Word, Excel, Powerpoint an advantage
  • Effectively and accurately writes and delivers employee-related documents on time and in accordance with company policies and timelines
  • Working knowledge of and experience applying EU & US medical device regulations and guidance documents
  • Ensuring compliance with the current regulatory procedures and updating the procedures when new regulatory requirements become effective
  • Driving improvement in regulatory aspects of the Quality System, developing processes and documenting procedures to ensure an effective Quality System
5

Experience For Head of Regulatory Affairs Resume

  • Driving regulatory planning and ensure alignment with business and functional goals and priorities
  • Experience in writing and submitting regulatory documentation
  • Senior leadership experience, including line management of multiple levels of reporting is required
  • Perform re-audits as a way of assessing and documenting CAPA Effectiveness
  • Perform product regulatory review for health care business unit, prior to launching or initiation of advertising
  • Strong critical thinking, problem-solving, and analytical ability
  • Significant experience of leading complex regulatory submissions including MAAs. Leads Regulatory Project Team for TA
6

Experience For Regulatory Affairs Executive Resume

  • Strong customer focus, gaining insight of and understanding customer requirements
  • Previous experience in leading submission teams for investigational products and marketing applications
  • Thorough knowledge of system implementation and project management methodologies and experience in leading such a project on a large and international scale
  • + Experience managing employees
  • Savvy enough to understand the commercial priorities and identify opportunities that complement, building regulatory strategy which aligns to business need
  • Demonstrable experience in engaging externally with commercial partners, Regulatory authorities and industry associations
  • Experience in FDA submissions utilizing eCTD format and electronic submissions
  • Track record of managerial experience preferably including remote management
7

Experience For Regulatory Affairs Consultant Resume

  • Consult and guide teams tasked with delivering validated systems to the clients
  • Trained Good Manufacturing Practice (GMP), Environment Health Safety
  • Demonstrates the ability to foster long-term learning and develops Regulatory staff to become future leaders
  • Demonstrated track record of formulating global regulatory strategies that align with business deliverables is required
  • Direct and positive experience in communicating with Regulatory Authorities
  • Bachelors in Clinical Research, Physics, Biology, Engineering or related field (R.N.) or equivalent knowledge and experience
  • Good understanding of the drug and biologic product development process
8

Experience For Regulatory Affairs Supervisor Resume

  • Experience in writing preclinical, clinical and/or CMC sections of INDs and BLAs
  • Adapts to changing priorities
  • Demonstrates a systematic approach to solving problems
  • Act as the primary interface between the company and local regulatory authorities building good relationships in order to make Sanofi a recognized partner
  • Have at least 5 years’ experience in the pharmaceutical industry, including within Regulatory Affairs at affiliate level
  • Thrive in a fast paced work environment, while possessing the ability to quickly change priorities and perform multiple tasks simultaneously
  • RA/QS experience in a FDA regulated environment is required, including complaint management and documentation
  • Experience working in small molecule is also desirable
9

Experience For Regulatory Affairs Engineer Resume

  • Thrive in a fast-paced work environment, while possessing the ability to quickly change priorities and perform multiple tasks simultaneously
  • Experience of managing regulatory projects in global regulatory organizations
  • Experience managing international delegations desired
  • Strong knowledge of the Federal 3408 340B regulations & rule development processes in order to guide and support compliant program offering to clients
  • Knowledge of manufacturing processes and operations, automation, equipment/facilities validation
  • Experience in influencing institutional decision makers (Energy regulators, the Commission and Governments)
10

Experience For Regulatory Affairs Advisor Resume

  • Commercial experience of monetizing opportunities is a distinct advantage
  • Experience in Trading, Government Relations, Gas Commercial or Commercial B2B roles would be of benefit
  • Experience in Trading, Power Commercial or Commercial B2B roles would be of benefit
  • Experience working with companion diagnostic products
  • Experience in copy writing or editorial capacity

List of Typical Skills For a Regulatory Affairs Resume

1

Skills For Regulatory Affairs Director Resume

  • Demonstrated strong writing and communication skills. Ability to communicate effectively at multiple levels, including with regulatory authorities
  • Readily adapts to changing priorities, effectively manages own time, sets priorities to ensure tasks, multiple projects are prioritized and completed on time
  • Excellent negotiation, communication, and drafting skills demonstrated through work experience
  • Strong collaborator, focus on attention to detail, strong prioritization and organizational skills
  • Excellent leadership, presentation, collaborative and negotiation skills to work effectively with teams inside and outside the organization
  • A good team player with excellent communication skills and good working attitude
  • Strong interpersonal and written communication skills with the ability to communicate effectively across business functions
2

Skills For Director of Regulatory Affairs Resume

  • Be a team player as demonstrated by good communication/collaboration skills
  • Demonstrated effective written and oral communication and advocacy skills
  • Experience (preferably directing food regulatory compliance programs); leadership skills and people management experience
  • High level of professionalism, experience reviewing scientific information, demonstrated oral and written communication skills
  • Exceptional verbal and written communication skills including the ability to communicate effectively in a multicultural, multinational, matrix environment
  • Experience leading all licensing and permitting initiatives - oversight experience to include writing licenses and permits experience
  • Strong influencing skills, making timely decisions using relevant data; ability to work with different audience levels
  • Work independently without close supervision, meeting deadlines and demonstrating strong problem solving skills
3

Skills For Specialist, Regulatory Affairs Resume

  • Organizational leadership and management skills with a proven track record of delegating and directing staff
  • Strong planning, follow up, reporting, coordination and organization skills to achieve accurate and timely results
  • Have good English writing and speaking skills
  • Excellent written and verbal reasoning skillsRegulatory Affairs
  • Strong interpersonal, collaborative, problem solving and conflict resolution skills
  • Computer skills in Windows, Lotus e-mail, Excel, Power Point and work processing desirable. SAP experience highly desirable
  • Strong networking and communication skills- with the ability to influence others
4

Skills For Senior Specialist, Regulatory Affairs Resume

  • Strong computer literacy and computer skills including Word, Excel, PowerPoint, Outlook
  • Excellent problem solving skills and uses data to connect multiple ideas and develop solutions
  • Strong written and oral communication and advocacy skills
  • Excellent organizational, interpersonal, verbal/written communication skills are required
  • A team player with good communication and influencing skills
  • Have strong interpersonal skills, including the ability to remain calm, professional, diplomatic, and positive
  • Strong communication skills (orally and written)
  • Good language skills (English, local language, others appreciated)
  • Strong negotiating skills and ability to think creatively and develop creative solutions
5

Skills For Head of Regulatory Affairs Resume

  • Good IT skills and database manipulation
  • Good skills working with computers and office hardware
  • Strong written and verbal communication skills, particularly with regulators
  • Excellent writing skills. Proficient in Word/PowerPoint/Excel
  • Excellent documentation skills including record maintenance/tracking and understand document traceability
  • Excellent interpersonal and leadership / management skills are required, including appraisals and recruitment
  • Quick response, result oriented, respect the timeline, good project management skills
  • Excellent organizational, communication, negotiation and interpersonal skills is required
  • Meticulous attention to detail Good written and verbal communication skills
6

Skills For Regulatory Affairs Executive Resume

  • Excellent skills in advocacy (persuasion)
  • Good interpersonal skills and able to work well with cross-functional teams
  • Good oral/written communication & interpersonal skills
  • Excellent language skills (fluent or native) in German and English
  • Excellent writing, communication, organizational, and interpersonal skills are required
7

Skills For Regulatory Affairs Consultant Resume

  • Demonstrated ability to effectively coordinate projects and collaborate productively with both individuals and departments is required
  • Strong time management, process and project management, interpersonal and organizational skills
  • A proven track record of achievement with the ability to deal effectively with new and demanding changes to legislative and regulatory environment
  • Excellent interpersonal communications, verbal and written skills are required
  • Excellent organizational skills to accommodate difficult deadlines across several multiple regulators and businesses
  • Strong interpersonal skills with a collaborative and energetic style
  • Excellent legal research skills; advanced ability to locate, discern and apply relevant legal authority based upon knowledge of subject matter and business
8

Skills For Regulatory Affairs Supervisor Resume

  • Strong interpersonal and communications skills (oral and written)
  • Strong IT skills and ability to work with a variety of systems
  • Strong computer skills (PC, Windows, MS Office)
  • Strong management, written and verbal communication and presentation skills,
  • Strong project management skills; flexibility and initiative to work on multiple projects is required
9

Skills For Regulatory Affairs Engineer Resume

  • Strong organizational, communication and interpersonal skills is required
  • Proactive approach with strong organizational skills
  • Excellent communication skills (both written and verbal) and the ability to build networks and influence others
  • Working experience in Medical Device (class 1 and 2) is required, Cosmetic experience is nice to have
  • Working effectively in multinational/multicultural environments
  • Prior experience in creating, building, implementing and managing a Quality function
  • Competent English language skills (reading, writing, listening and speaking)
10

Skills For Regulatory Affairs Advisor Resume

  • Demonstrated experience in the regulatory review and requirements pertaining to advertising/promotional materials for prescription products
  • Intermediate skills in interpreting modeling results provided by consultants
  • Experience reviewing regulatory affairs elements of Clinical Evaluation Reports (CER), Risk Management files, Verification and Validation Reports, labeling
  • Experience in developing strong working relationships with regulators and external groups (e.g., trade associations, etc.)
  • Global filing experience or a lot of Regional filing experience
  • Conveys trust in others' knowledge, skills & judgment & provides direct reports & team members with appropriate levels of autonomy & decision-making authority

List of Typical Responsibilities For a Regulatory Affairs Resume

1

Responsibilities For Regulatory Affairs Director Resume

  • Advise NBCUniversal-owned cable networks on applicable FCC regulatory requirements, including program access/program carriage rules, commercial limits in children’s programming, closed captioning/video descriptions
  • Demonstrated organizational skills, communication and interpersonal skills, and attention to detail
  • Good communication skills to cooperate with different individuals in a polite and consequent way
  • Excellent verbal and written skills, effective communication and teamwork
  • Great oral and written communication skills to effectively communicate with team members
  • Good problem-solving, organizational, analytical and critical thinking skills needed to drive progress
  • Excellent analytical and problem solving skills, with senior level competency in managing ambiguous situations and issues
  • Proven quality control analysis, complex problem solving, judgment and financial management skills
  • + Multi-tasks and prioritizes effectively in fast-paced environment
2

Responsibilities For Director of Regulatory Affairs Resume

  • Excellent English and German skills, other languages are an asset
  • Excellent writing and English grammar skills
  • Excellent negotiation skills across levels within an organization and with external stakeholders
  • Strong Microsoft Office skills (especially Excel, Word and PowerPoint)
  • Demonstrated communications, and interpersonal skills
  • Proactive approach and excellent communication skills (written and verbal)
  • Reliable conscientious worker with proven communication skills
3

Responsibilities For Specialist, Regulatory Affairs Resume

  • Detail-oriented with strong organizational and information-gathering skills
  • Demonstrated verbal/written communication skills and ability to work with cross-functional teams
  • Strong computer skills, i.e. Word, Excel, Power Point, etc
  • Work effectively across the organization and externally with sponsor organizations to ensure effective and efficient conduct of clinical research
  • Excellent verbal and written communication and advocacy skills
  • Strong communicative and stakeholder management skills
  • Excellent written/spoken communication and negotiation skills
4

Responsibilities For Senior Specialist, Regulatory Affairs Resume

  • English skill: Good at listening, speaking, reading and writing
  • Technical systems skills (e.g. word processing, spreadsheets, databases)
  • Demonstrated ability to form, lead and manage cross-functional, cross-business teams; significant experience leading regulatory strategy and regulatory teams
  • Exercise independent judgment, and to work with and maintain confidential and sensitive information, while also working effectively within a team
  • Proven experience in preparing Module 3 sections of Common Technical Documents which are suitable for successful global registrations
  • Skills :Analytical and problem-solving
  • Deal with and resolve complex situations by means of communication, negotiation and influencing skills
  • Anticipation and Planning Skills
5

Responsibilities For Head of Regulatory Affairs Resume

  • Communicate effectively, especially through written media
  • Partners effectively with the various AMRI regulatory teams to ensure alignment of regulatory strategies and practices
  • Interacts effectively with peers and supervisors
  • Proven recent experience of preparing and authoring complex regulatory submissions for medical devices and biological products
  • Superb organizational skills and attention to detail and ability to manage multiple project timelines
  • Interprets general business objectives and effectively present information to manager and regions
  • Demonstrated experience in Companion Diagnostic Regulatory Affairs (e.g. PMA submissions, CE markings) is also required
6

Responsibilities For Regulatory Affairs Executive Resume

  • Experience in Utilization Review, Prior Authorization and Appeals
  • Experience with strong knowledge of quality system requirements specifically FDA’s 21 CFR Part 820
  • Regulatory submissions experience, experience interacting with regulatory agencies
  • Skills of data collection and processing
  • Demonstrated ability to manage multiple tasks/projects/priorities simultaneously is required
  • Further develop your background in analytical and communications skills
  • Management experience or equivalent experience
7

Responsibilities For Regulatory Affairs Consultant Resume

  • Prioritizes and manages multiple projects and organize workloads, with effective outcomes
  • Plan and prioritise multiple projects, with high priority on deadlines and customer care
  • Skills: Proficient in Microsoft Office
  • Communicate and write English clearly, concisely, and effectively
  • Prior clinical drug development experience
8

Responsibilities For Regulatory Affairs Supervisor Resume

  • Knowledgeable of ICH, 21 CFR Part 11 and experienced in electronic submission experience (drugs, biologics, and gene therapy products) required
  • Demonstrated ability to manage priorities, multi-task, and follow projects through to completion
  • General computer skills and IT literacy
  • Stellar communication skills, both written and oral
  • Management and operation skills
  • Significant experience of effective interaction with FDA and its relevant divisions
  • Prior experience with regulatory project management and management of regulatory projects in global regulatory organizations
  • A demonstrated ability to produce excellent quality outcomes and member satisfaction
9

Responsibilities For Regulatory Affairs Engineer Resume

  • Previous demonstrated experience working in a radiation oncology environment
  • Would benefit from PSUR update experience, management of CCDS updates and submission experience of simple and complex variations to EU markets,
  • Coordinate and work effectively with different key stakeholder teams
  • Organizational and analytical skills with attention to detail
  • Relevant pharmaceutical industry and regulatory experience (or 2+ years Pharmaceutical Regulatory experience with a Masters in Regulatory Affairs)
10

Responsibilities For Regulatory Affairs Advisor Resume

  • Demonstrable experience across the Drug, Discovery, Development and commercialization lifecycle, with proven examples of contribution
  • General management experience and previous line management and leadership experience at senior management level is essential
  • Demonstrable experience of effective delivery in a complex matrix environment
  • Effectively interact with external business partners and Regulatory Agencies
  • Relevant Experience :2 years experience in Regulatory Affairs
  • IT Skills (proficient in MS Office (Word, Excel, Powerpoint))
  • Builds strong alliances and effective networks with wider BAT Group LEX community to ensure two way flow of communications on local issues
  • University graduate with at least 3 years relevant experience with solid knowledge of government functions and policies
  • Carrying out other activities which contribute to the effective performance of the Regulatory Affairs Department

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