Regulatory Strategy Job Description
Regulatory strategy
provides national and international regulatory and product development advice on the development and commercial production of biological and drug products.
Regulatory Strategy Duties & Responsibilities
To write an effective regulatory strategy job description, begin by listing detailed duties, responsibilities and expectations. We have included regulatory strategy job description templates that you can modify and use.
Sample responsibilities for this position include:
Generally lead stakeholder reporting (IHC Board, Risk and Capital Committee, etc) and communication to ensure a consistent view to all stakeholders on regulatory progress, MRA tracking, gap closure
Responsible for mentoring junior members of the regulatory team
Effectively partnering with all levels of personnel within Global Compliance, GFCC, and/or LOB Compliance, the business, corporate functions and our partners in Legal, Oversight & Controls and Internal Audit
Be accountable to the Core Working Group for reporting (weekly key messages and other consolidated reporting), documentation, presentations
With the oversight of the Director, Regulatory Labeling Strategy, manages and facilitates development and review of the CCDS, US and EU labeling via the Shire Labeling Teams
Key lead on the Regulatory Strategy and Engagement to ensure regulatory scope coverage, which covers six core rules and 13 supplemental guidance documents, and manage the associated supporting and evidentiary documentation
Co-lead stakeholder reporting (IHC Board, Risk and Capital Committee, etc) and communication to ensure a consistent view to all stakeholders on regulatory progress, MRA tracking, gap closure
Key lead for regulatory engagement and managing any regulatory follow-up and key advisor on regulatory strategy and communications
Manage engagement with industry forums on key regulatory issues
Subject matter expert on Section 165-related requirements
Regulatory Strategy Qualifications
Qualifications for a job description may include education, certification, and experience.
Licensing or Certifications for Regulatory Strategy
List any licenses or certifications required by the position: RAC, GMP, PMP, MBA
Education for Regulatory Strategy
Typically a job would require a certain level of education.
Employers hiring for the regulatory strategy job most commonly would prefer for their future employee to have a relevant degree such as Bachelor's and Master's Degree in Life Sciences, Engineering, Business, Technical, Finance, Pharmacy, Accounting, Economics, Biology, Science
Skills for Regulatory Strategy
Desired skills for regulatory strategy include:
Relevant industry practice and legislation
Data management
Company policies and practices
National Grid's business operations
Broad experience with regulatory procedures and legislation for drug development
Product registration
Drug development process and regulatory requirements
Oncology drug development is desired
Preparation of major regulatory submissions and supportive amendments
Supplements
Desired experience for regulatory strategy includes:
Understanding of Electronic Document Management Systems to a sufficient level to support labeling documentation
Proven experience in drug/biologics development the EU pharmaceutical and biotechnology industry or Government Health Agency
Knowledge of the drug development process and laws and regulations affecting pharmaceutical development in EU region
Depending on the role, required professional certification (e.g., CAMS, CISA, CRCM, CCRP, CIA, CFSA, CPA, ) is desired
Support implementation efforts for regulation, the internal TRANSFORM agenda, structural reform, among other regulatory and internal structural initiatives
10+ years of post Bachelors experience in Investment Banking/Financial Services or at a Regulatory Agency
Regulatory Strategy Examples
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Regulatory Strategy Job Description
Job Description Example
Our growing company is hiring for a regulatory strategy. If you are looking for an exciting place to work, please take a look at the list of qualifications below.
Responsibilities for regulatory strategy
- Support stakeholder reporting (IHC Board, Risk and Capital Committee, etc) and communication to ensure a consistent view to all stakeholders on regulatory progress, MRA tracking, gap closure
- Collaborate with workstreams to ensure consistent quality management across projects and resolution of routine challenges and issues
- Support the coordination CCAR business readiness exercises and end-to-end dry run
- A Bachelor’s degree or above
- Expertise and experience in strategy/business planning
- Strategic thinking skills – the ability to understand broad business issues and their strategic implications and to make sound business recommendations
- Fluent in English written and oral (German also preferred)
- Located in London or Frankfurt
- Presenting the analysis and insights in meetings or workshops with clients, and at industry seminars and conferences
- Advise clients on the impacts of the regulatory changes on their specific operating models and identify the potential existing gaps in their current set-ups
Qualifications for regulatory strategy
- Technical background in vehicles emissions and environmental topics including air quality, greenhouse gases, fuel economy technologies
- Ability to work across several streams simultaneously
- Proficient in Microsoft Project, Excel, Microsoft PowerPoint, Visio
- Substantial experience in regulatory environment within the insurance industry
- Demonstrable experience in insurance prudential regulation, with particular focus on Solvency II Pillar I standards and the PRA’s approach to insurance prudential supervision, of the latest regulatory developments and current issues facing regulated insurers in the UK and EU
- Proven track record in understanding and interpreting regulation within the insurance industry, assessing its financial, strategic and operational impact on firms, and implementing solutions to address regulatory requirements
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Regulatory Strategy Job Description
Job Description Example
Our growing company is searching for experienced candidates for the position of regulatory strategy. If you are looking for an exciting place to work, please take a look at the list of qualifications below.
Responsibilities for regulatory strategy
- Participate in translating directives and regulations into practical and pragmatic business requirements and solutions for our clients
- Intervene as regulatory Subject Matter Expert on Regulatory Strategy assignments
- Participate to regulatory authorisation related assignments for Management Companies, Professionals of the Financial Sector or Banks
- Supporting executive decision making within the Regulatory affairs division, the Management Board by providing accurate insights and analysis to take strategic decisions within the regulatory space
- Serve as global regulatory lead accountable for all regulatory aspects of assigned project(s), including development and implementation of the global regulatory development plan for the project
- Represent GRA on cross-functional teams, including product development teams, study execution teams, clinical development task-forces and commercial sub-teams
- Serve as point of contact with regulatory authorities, contractors and corporate partners, where relevant, for specific projects
- Prepare, review and/or approve regulatory submission documents and Agency communications
- Conduct due diligence activities for potential partnerships and collaborations, as needed
- Contribute to the continuous improvement of existing department processes and strategies, providing recommendations in their area of expertise
Qualifications for regulatory strategy
- Proficiency or aptitude in common database and data analytics languages
- Lead/Participate in Global Regulatory Teams (GRTs) Provide leadership to the global regulatory teams on critical project issues
- Assure priority market and non-priority market regulatory issues are addressed in development plans
- Provide strategic regulatory input to key development documents, including clinical protocols, clinical and nonclinical reports and summary documents, statistical analysis plans, DMC charters
- Review and approve key regulatory documents, including IB, IND, IMPDs, CTAs, RMP, Pediatric plans
- Support the preparation of, and participate in / lead (as appropriate), key HA interactions
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Regulatory Strategy Job Description
Job Description Example
Our company is growing rapidly and is looking for a regulatory strategy. If you are looking for an exciting place to work, please take a look at the list of qualifications below.
Responsibilities for regulatory strategy
- Monitor and review financial information, updating where necessary in order to identify any anomalies or discrepancies and ensure management has access to up to date and accurate information to support the development of regulatory strategies and preparation of regulatory filings
- Develop pricing and tariff process and policy specifications and criteria and options and evaluate those options to support senior management decision-making in the application of regulation and pricing, such as in general rate cases, comprehensive rate plan filings and tariff administration proceedings
- Serve as a Global Labelling subject matter expert for all matters relating to the CCPIL
- Partner with Global Regulatory Leads and Company Core Datasheet (CCDS) teams to lead the evaluation, development and maintenance of CCPIL for assigned products
- Develop and maintain SOPs related to CCPIL
- Ensure local labelling complies with CCPIL where appropriate and ensure that all deviations are identified
- Review and assess impact of regulatory initiatives related to labelling IDMP, Braille, packaging and labelling systems readability and user consultation
- May lead industry association involvement on labelling topics, with EFPIA, DIA, LabelNet and other groups as necessary
- Assist in the design and implementation of best practices for the development of new labeling review and approval procedures and evaluation of existing procedures for practical application
- Assist Global/Regional Regulatory leads with development, quality control and submission of labelling to ensure compliance with new or revised CCDSs and associated CCDS implementation plans
Qualifications for regulatory strategy
- This position must represent the interests of the Volkswagen Group on regulatory issues and serve as a "technical lobbyist/advocate" with regards to influencing and shaping future environmental requirements
- Solid scientific background, Ph.D., M.D., PharmD, MS, or BS with equivalent professional experience
- Ability to broadly represent department functions on project team in a matrix organization
- Experience in the pharmaceutical industry required with 5+ years direct regulatory affairs experience, including ex US regulatory experience
- Candidate should be comfortable working independently to create Health Authority correspondence (including request for Health Authority consultations), and attending specific project team meetings (such as Clinical Study Team Meetings) as the Regulatory Affairs Representative and providing guidance to project teams on all areas of pharmaceutical drug development (ICH, 21CFR)
- Serve as a primary contact with the FDA
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Regulatory Strategy Job Description
Job Description Example
Our innovative and growing company is searching for experienced candidates for the position of regulatory strategy. We appreciate you taking the time to review the list of qualifications and to apply for the position. If you don’t fill all of the qualifications, you may still be considered depending on your level of experience.
Responsibilities for regulatory strategy
- Act as the Subject Matter Expert for readability testing and oversee readability and bridging projects as required
- Lead development of labelling negotiation strategies, including discussions with EMA (QRD, CHMP, PIQ teams)
- Manage and coordinate pre- and post-approval labelling translation, in compliance with EU/International guidance
- Monitor the quality of the language versions of the labelling provided to Health Authorities, identify translation issues and work to design and implement new labelling translations development, review and approval procedures
- Contribute to cross-project language harmonisation (semantic, sentence structure and style)
- Review and monitor change control workflows for updates to labelling text and artwork
- May mentor other RA team members
- Develop vendor strategy and preferred suppliers (where appropriate) for user testing, translation services and linguistic tools
- Review and assess impact of regulatory initiatives related to labelling
- Lead industry association involvement on labelling topics, with EFPIA, DIA, LabelNet and other groups as necessary
Qualifications for regulatory strategy
- Bachelors or Masters or advanced degree in a scientific discipline, with 3-5 years of increasingly responsible regulatory experience in the pharmaceutical industry
- Exceptional interpersonal skills with the ability to work individually, within a multi-disciplinary team, with external partners and regulators
- Ability to cultivate internal and external relationships based on trust and respect in anticipation of future working relationships
- Fluency in languages, in addition to English, would be a plus
- A Bachelor's degree in accounting, economics, finance, engineering, or related field and up to 7 years of related experience, or equivalent work experience
- Ability to communicate tactfully and effectively, both orally and in writing, and must be able to present information in a clear and concise manner to large groups, senior management
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Regulatory Strategy Job Description
Job Description Example
Our company is searching for experienced candidates for the position of regulatory strategy. Thank you in advance for taking a look at the list of responsibilities and qualifications. We look forward to reviewing your resume.
Responsibilities for regulatory strategy
- Accountable for the interaction between the group and Affiliate Regulatory Affairs ensuring that local labelling complies with the Company Core Data Sheet (CCDS), deviations are identified and managed appropriately and all parties are informed and updated on a timely basis
- Manage & coordinate pre- and post-approval labelling translation, in compliance with EU/International guidance, including exchanges with EEA Health Authorities (and liaison with Middle East & African authorities when required)
- Review and monitor change control workflows for updates to labelling text and artwork for multiple products marketed across the globe
- Proactively identify potential issues and escalate to management for resolution
- May have responsibility for the development, maintenance and global implementation of core patient information leaflet
- Oversee maintenance of regulatory labelling and artwork repositories within the electronic document management system
- Accountable for the archiving of packaging artwork, including vial and container labels
- Responsible for leading, managing, developing and coaching the regulatory labelling and translation team
- Will be a member of the RA EMEA Franchise Leadership Team
- Oversee the development and management of suppliers/consultants for labelling and translation services ensuring projects are completed within budget
Qualifications for regulatory strategy
- Healthcare professional training & experience (RN, Pharm
- Bachelors or Masters or advanced degree in a scientific discipline, with a minimum of 6 years of increasingly responsible regulatory experience in the biopharmaceutical industry
- Ability to work with minimal supervision, to set priorities to meet timelines, to motivate others, and influence others
- Extensive knowledge of drug development, regulatory submissions and approval processes, including labelling requirements throughout the product lifecycle
- In-depth knowledge of health authority labelling regulations in Europe and ROW
- In-depth knowledge of labelling layout and design