Regulatory Strategy Resume Sample

5.0
1 vote
Lorena Mosciski
635 Emard Curve,  Chicago, IL
+1 (555) 492 2879

Work Experience


Senior Rates & Regulatory Strategy Analyst
12/2015 - PRESENT
Phoenix, AZ
  • Benchmarking regulatory guidance across jurisdictions to UBS's Sourcing Framework and recommending changes; reviewing and providing feedback to new and draft circulars
  • Accountable for defining the International regulatory strategy for assigned products (maintaining and extending Shire product registrations in International markets)
  • Collaborates closely with all other key GRA stakeholders (including but not limited to Global Regulatory Lead, labeling, CMC, regulatory operations, EU regulatory team and regulatory staff in the International LOCs) to ensure that all aspects of the regional strategy is coordinated and considered
  • Under direction of the Head International Regulatory Strategy Group, works in close collaboration with GRL to ensure that the International strategy is appropriately represented within the global strategy and at the appropriate forums (PST, Development Teams etc) through the GRL
  • Provides regional regulatory expertise to GRL and within GRT by collaborating with International LOC
  • Works in close collaboration with the GRL and International LOC’s in providing support to meetings with Health Authorities (where needed)
  • Acts as International regulatory strategy lead for all applications conducted in the International region, coordinating with the assigned CRO (where appropriate) and functional stakeholders to ensure the timely submission, approval and compliance of all applications
  • Ensure timely updates to product core dossiers
CIB F&BM Reg W Regulatory Strategy Controller
05/2013 - 11/2015
Detroit, MI
  • Ensure appropriate archiving of all submissions performed on international market by collaborating with International LOC and Reg Ops
  • Ensures documentations like Labelling tracker and Product History templates are updated in a timely manner (where needed)
  • Work closely with International LOC in ensuring that artwork (e.g. request for mock-ups) to support product registration is generated on time
  • Experience in Operational Risk Framework ("ORF 2"), risk management and reporting
  • Project management coordination background
  • Offshoring, nearshoring, outsourcing experience
  • Very good communications development skills (written reports and slide presentations)
Regulatory & Strategy Officer Based
08/2008 - 02/2013
Dallas, TX
  • Expertise in MS Excel, MS PowerPoint and SharePoint
  • Multi-task and very good organization skills
  • Accountable for defining the EU regulatory strategy for assigned products (maintaining and extending Shire product registrations in EU markets)
  • Partnering with their GRA counterpart in the LOC, the individual is the regulatory expert for assigned countries within the EU, ensuring that knowledge is transferred throughout the EU Regulatory team,
  • Ensure a high performance environment, i.e.: ensuring prioritization of key topics and projects, adequate and timely staffing for the projects, good coordination of the key team processes, ongoing coaching and professional development of all team members
  • Participates in the rulemaking process by interacting with internal and external groups, including analysis and response to proposed regulations (including trade organization discussions, workshops, comment preparation)
  • Provides frequent, in-depth interpretation of regulatory requirements throughout the Volkswagen Group. Maintains a history of results to streamline future requests and build a knowledge banks
  • Leads coordinated activities between the Regulatory and Certification teams within the EEO to identify beneficial regulatory compliance options and credit opportunities with regards to Green House Gas Emissions, Fuel Economy, Tail Pipe Emissions and Fuel Regulations, and Air Toxics Regulations

Education


West Coast University
2003 - 2008
Bachelor's Degree in Pharmacy

Professional Skills


  • Working in a matrix structure and with cross functional teams, requiring strong negotiation and influencing skills
  • Communication - Strong written and oral communication, listening, and non-verbal communication skills
  • Working in a matrix structure and with cross functional teams, requiring negotiation and partnership skills
  • Influencing and negotiations skills
  • Problem Solving - Uses different methods such as critical thinking skills to solve problems by generating, evaluating, and implementing solutions
  • Excellent senior experience working with legislative institutions (EU, UK, US, more is desirable) and decision making process – essential
  • Prior experience managing substantial projects or programs is desired for more senior levels

How to write Regulatory Strategy Resume

Regulatory Strategy role is responsible for organization, negotiation, communications, reporting, retail, finance, credit, training, marketing, procurement.
To write great resume for regulatory strategy job, your resume must include:

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

Contact Information For Regulatory Strategy Resume

The section contact information is important in your regulatory strategy 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 Strategy Resume

The section work experience is an essential part of your regulatory strategy 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 strategy 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 strategy position you're applying to. The work experience section should be the detailed summary of your latest 3 or 4 positions. Representative Regulatory Strategy resume experience can include:

  • Very good writing and presentation skills
  • Demonstrated leadership success in management, including building and/or leading a regulatory affairs team or department
  • Success working independently, handling multiple tasks, and determining priorities in a team environment
  • Good understanding of basel regulations for market risk
  • Manage multiple priorities to ensure high-quality results while meeting deadlines in a fast-paced environment
  • Maintain effective working relationships with management, peers, regulators, and customers

Education on a Regulatory Strategy Resume

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

When listing skills on your regulatory strategy 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 strategy skills:

  • Knowledge of EU regulatory requirements and ability to use precedent and previous experience to develop creative approaches to achieving commercial goals
  • Sit or stand for long periods of time while traveling
  • Occasional overtime required to meet deadlines, with more extensive overtime required during periods of rate cases
  • Passionate about utilizing her or his industry expertise to help realize SolarCity’s vision of distributed energy resources in every home
  • RAC certification desirable but not mandatory
  • Knowledge of the drug development process and laws and regulations affecting pharmaceutical development in EU region. Prior experience and a track record of success in working with EMA & national agencies in the EU is required

List of Typical Experience For a Regulatory Strategy Resume

1

Experience For Senior Rates & Regulatory Strategy Analyst Resume

  • Strong experience in drug/biologics development either within the pharmaceutical and biotechnology industry or Government Health Agency,
  • In collaboration with the global regulatory team (GRT), develop global submission plans and Health Authority interaction plans
  • Responsible and accountable for defining the International regulatory strategy for assigned products (maintaining and extending Shire product registrations in International markets)
  • Designs international regulatory strategy for products that they are accountable for in close collaboration with the GRL to obtain, maintain and extend Shire products registration in the international markets
  • Provides regional regulatory expertise to the GRL and within GRT by collaborating with the International LOC
  • Ensure international strategy is appropriately represented within the GRT and at other appropriate forums (LPT, Global Development Team etc) through the GRL
2

Experience For Global Head of Regulatory Strategy Resume

  • In collaboration with cross-functional team, ensure timely updates to product core dossiers for the assigned products
  • Ensures that regulatory submission and approval notification is communicated to appropriate functions within the defined timeframe to allow implementation
  • Lead on high-quality technical position papers / briefings / consultation responses
  • Manage team’s budget and trade associations presence under the supervision of Global Head of Regulatory Strategy and with the expert support of Head of Brussels Representative Office where needed
  • Provide full clarity and transparency on the Post-Trade and Technology priorities and engagement plan to ensure coordination and visibility within the Global team
  • Co-lead rotation with other members of the Global Regulatory Strategy team to build the appropriate reports for top management and ExCo level on the activities of the Regulatory Strategy department. Co-responsible for excellent quality of any document coming out of the Global Regulatory Strategy Team
  • Excellent detailed analytical and problem solving skills – good experience of analysing UK and / or European and / or US financial services regulation is required
3

Experience For Senior Director Global Regulatory Strategy Resume

  • Delivery – ability to manage a team and deliver high-quality work according to line manage strategy, business goals and deadlines. Ability to provide structured feedback, clarity and transparency – essential
  • Experience of financial services applicable to the Group’s Post-Trade and Technology activities - essential
  • Managing relationships – ability to build and maintain the relevant network of contacts, internally and externally. Ability to manage up and down internally
  • Proven ability to drive issues in autonomy, working proactively to achieve the optimum outcomes in line with line manager strategy, manage skilled external and internal stakeholders and provide full clarity to reporting line – essential
  • Model, analyze and communicate historical and forecasted revenue requirements, earnings, returns, cost of capital and customer rate implications in support of ratemaking and legislative strategies
  • Gain and apply an extensive knowledge of the Utilities International UIPlanner software tool in order to design and model complex regulatory reports for allocating cost of service by customer rate class, rate case filing requirements, and earnings surveillance reporting
4

Experience For Director of Global Regulatory Strategy Resume

  • Participate in general rate case activities to seek appropriate cost recovery, including performing research, gathering and analyzing data, coordinating with multiple departments, developing written testimony and exhibits, responding to external discovery requests, etc
  • Provide regulatory expertise/support in the development and successful implementation of business initiatives. Identify potential regulatory issues/hurdles and propose solutions and strategies to overcome barriers
  • Calculate and analyze revenue requirements, earnings, return on equity and customer rate impacts of various ratemaking and legislative strategies
  • File earnings surveillance reports with the Florida Public Service Commission by appropriately adjusting and allocating revenues, costs, assets, liabilities, and capital to retail and wholesale customers
  • Gain and apply an in depth knowledge of the Utilities International (UIPlanner) software tool in order to develop earnings surveillance and other regulatory reports
5

Experience For Senior / Regulatory Strategy Director Resume

  • Prior equivalent work related experience
  • 2 Cost of service, rate and pricing, modeling and financial analysis work
  • 4 Regulatory strategy analysis, reporting and support
  • 5 Resolving strategic company or jurisdictional initiatives
  • 1 Rate case/ Rider filings & Support
6

Experience For Senior Director, Regulatory Strategy Resume

  • 3 Regulatory filings, compliance activities and shared service rate work
  • Develop new regulatory frameworks and utility business models, such as outcome/results/performance-based regulation, and renewable energy policy and regulation
  • Provide regulatory leadership in all “utility of the future”-related efforts, such as New York’s Reforming the Energy Vision (NY REV), Massachusetts Grid Modernization (Grid Mod), and Rhode Island Power Sector Transformation (RI PST)
  • Work cooperatively with peer utility representatives in coordinating “utility of the future” activities and programs
  • Engage with key stakeholders on “utility of the future”-related matters, including regulators, technology providers, and environmental and other public interest advocates
7

Experience For Associate Director Global Regulatory Strategy Oncology Resume

  • Provide high-quality written communication for senior leadership (e.g., presentations, memos) and for external stakeholders (e.g., regulatory testimony and other filings)
  • Demonstrated ability to quickly grasp complex issues and effectively integrate, compile, and analyze complex information and data
  • Develop or contribute to design and editing of regulations and tariffs that would govern new utility programs and activities
  • Keep abreast of the latest relevant industry developments and represent National Grid in relevant industry and public forums
  • Understanding of current trends within the utility industry, particularly with regard to grid modernization/”smart grid,” time-varying rates, demand response, energy efficiency, distributed energy resources, and outcome/results-based ratemaking
  • Quantitative analysis acumen (i.e., advanced MS Excel capabilities and/or statistical programming, e.g., SAS/Stata/R)
  • Proficient in other relevant software, i.e., Microsoft Office (Word, Powerpoint, Outlook)
8

Experience For Director Regulatory Strategy Resume

  • Travel anticipated
  • Sharp, structured and efficient management of the Post-Trade and Technology Regulatory Strategy team, accountability for final products coming out of this team. Work in close cooperation with his/her peers, the Global Head of Capital Markets, Regulatory Strategy and the Global Head of Information Services, Regulatory Strategy to support the Global Head of Regulatory Strategy vision and decisions
  • Be accountable for structured, filtered for decision-making, clear written analysis of regulatory developments, measuring impact on the Post-Trade and Technology businesses, working out scenarios and recommending appropriate action to the Global Head of Regulatory Strategy. Be conscious of the prioritisation required on the basis of revenue, business and reputational risks
  • File monthly actual and annual forecasted earnings surveillance reports with the Florida Public Service Commission by applying a highly proficient knowledge of utility financial statements and ratemaking concepts in order to appropriately allocate all revenues, costs, assets, liabilities, and capital to retail and wholesale customers under the various recovery mechanisms

List of Typical Skills For a Regulatory Strategy Resume

1

Skills For Senior Rates & Regulatory Strategy Analyst Resume

  • Work independently to propose solutions to complex problems, taking into consideration external factors (e.g commercial implications etc) that would be impacted by the decision
  • Working in a matrix structure and with cross functional teams, requiring negotiation and partnering skills
  • Dealing with Ambiguity – Ability to effectively cope with uncertainty, maintain composure and shift gears comfortably
  • A proven track record of effective collaboration with regulatory agencies, including the FDA
  • Proficient in Microsoft Products: Excel (advance skills), Word, and PowerPoint
2

Skills For Global Head of Regulatory Strategy Resume

  • Effectively manage tasks and projects with limited guidance
  • Excellent understanding of Basel regulations for market risk
  • Utility, regulatory, and/or rate case work experience
  • Experience with Utilities International “UIPlanner” software tool
  • Experience in drug development in the Pharma, biotech or CRO industry
  • Experience in a financial institution/regulator preferably in risk/audit/compliance
  • Internal audit or policy development experience would be desirable
3

Skills For Senior Director Global Regulatory Strategy Resume

  • Comprehensive understanding of accounting/financial principles
  • Creative problem solving and strategizing abilities
  • Develop target labeling and co-lead the cross-functional labeling team
  • Knowledge of an Asian language would be an advantages when speaking with internal and external stakeholders (Japanese/Chinese/Korean)
  • Travel is estimated to be 25 % of the time
4

Skills For Director of Global Regulatory Strategy Resume

  • Normal office environment with extensive use of a computer
  • Collaboration/Teamwork – Ability to effectively collaborate with internal and cross functional colleagues at all levels of the organization to achieve business objectives
  • Influence - Ability to analyze a situation and adopt different strategies in a variety of situations to achieve outcomes
  • Strategic Agility – Ability to anticipate future consequences and trends accurately based on broad knowledge and industry perspective and to create and adapt strategies accordingly to achieve objectives
  • Emotional Intelligence - Ability to perceive and understand his or her emotions and the emotions of others
  • Results Driven – Ability to focus on desired results and work hard to achieve what’s important
  • Developing and Motivating Others – Ability to create a climate in which people want to do their best; motivate many kinds of direct reports and/or teams; is someone people like working for and with
5

Skills For Senior / Regulatory Strategy Director Resume

  • Broad intelligence of regulatory environment across key regions, anticipation of future trends and impact
  • Demonstrated expertise in at least one area of clinical product development: chemistry, manufacturing, and controls development, non-clinical development, or clinical development
  • Familiarity with the FERC Uniform System of Accounts
  • CPA, CMA and/or Master's level education
  • Attention to detail with high level of accuracy and motivation
  • Comprehend and perform advanced Excel functions
  • Employees at this level are able to perform proficiently at the Rates & Regulatory Strategy Analyst requirements and is demonstrating the ability to perform at the Senior Rates & Regulatory Strategy Analyst requirements
  • 5-10% travel required mostly within North America
6

Skills For Senior Director, Regulatory Strategy Resume

  • Flexibility with travel requirements, with an expectation of up to 30% travel time
  • Knowledge of International regulatory requirements and ability to use precedent and previous experience to develop creative approaches to achieving commercial goals
  • Knowledge of the drug development process and laws and regulations affecting pharmaceutical development in International region. Prior experience and a track record of success in working with International partners (LOC’s/distributors)
  • Experience developing global regulatory strategies for early and late stage development programs
  • At least four years of relevant working experience (in regulatory, legal, compliance, risk or other related area)
  • Contribute to making an impact on our society, people and environment
7

Skills For Associate Director Global Regulatory Strategy Oncology Resume

  • Expertise in Excel, PowerPoint, SharePoint
  • Knowledge of an Asian language would be an advantage (Japanese/Chinese/Korean)
  • Profit from an attractive package of customizable advantages
  • Profit from our Global network for career opportunities
  • Under direction of EU Regulatory Strategy Team Lead, designs EU regulatory strategies in close collaboration with GRL to obtain, maintain and extend Shire product registrations in Europe
  • Leads and chairs cross-functional submission teams to ensure creation and submission of qualitative regulatory documents (MA, Briefing documents, Variations, ODD, PIP, responses to questions and other relevant regulatory filings) within defined timelines as per company objectives
  • Acts as regulatory lead for CTA applications conducted in the European region, coordinating with the assigned CRO and functional stakeholders to ensure the timely submission, approval and compliance of all CTA applications
  • Ensure appropriate contacts with relevant regulatory agencies, especially the European Medicines Agency and other regulatory agencies in the EU member states to ensure the regulatory applications are approved in a timely manner
  • Remains knowledgeable about current regulations and guidance, interprets and notifies appropriate personnel and remains in compliance with all current Shire trainings and internal processes,
8

Skills For Director Regulatory Strategy Resume

  • Ensure clarity of demand and manage prioritization and resource reallocation
  • Represents VWGoA with Regulatory Agencies and serves as expert contact to VWGoA Groups and teams in Herndon
  • Negotiates, makes proposals, and shapes/models future regulations with Agencies
  • Educates VWGoA Organization with regards to future regulations and drafts comments to Agencies on behalf of Company
  • Improve connectivity across the CB&S Finance functions
  • Optimize chances for standardization of new RTB processes
9

Skills For CIB F&BM Reg W Regulatory Strategy Controller Resume

  • Ease navigation of Global Markets Finance for Program leads and Business stakeholders
  • Lead group research and preparation for intervention in regulatory proceedings on utility revenue requirements, cost of service, rate designs, and other strategically important topics
  • Develop nationally repeatable, evidence-based analytical approaches and strategies for SolarCity on critical technical and economic issues that impact SolarCity’s business
  • Effectively leverage internal and external resources to drive positive regulatory and policy outcomes, including serving as the lead liaison to SolarCity’s Policy team on regulatory strategy
  • Deep and broad knowledge of worldwide regulatory affairs; direct experience with pharmaceutical regulatory submissions and product approvals worldwide
  • Work with minimal supervision, to set priorities to meet timelines, to motivate others, and to manage budgets
  • Actively supporting Deutsche Bank’s strategy, plans and values, contributing to the achievement of a high performance culture
  • Maintain a thorough understanding of SolarCity’s full product suite and its relevance and application to policy discussions
10

Skills For Associate Director Global Regulatory Strategy Immuno Resume

  • Support the company’s commercial products
  • Collaborate with the Global Regulatory Affairs group in providing support and input for one another’s projects based on past therapeutic experience and global, regional and local regulatory expertise
  • Work with Covance functional areas and clients to assess and/or develop the highest quality advice on regulatory strategy, supporting non-clinical development to first in human studies for client products by maintaining awareness of current regulatory legislation, guidance’s, precedence and current thinking within Agencies
  • Evaluates the impact of clinical/regulatory changes on client’s projects as well as Covance business practices
  • Develop and promote Covance’s capability to provide a specialized regulatory and scientific service by supporting existing projects/clients and by identifying and pursuing opportunities to expand regulatory activities
  • Compile and submits IND and clinical trial applications (CTA’s) in order to enable timely start of the clinical trials for the assigned development products with oversight from Lead GRS and supervisor
  • Ensure consistent positions are presented in responses to global health authority (HA) queries

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