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Regulatory Lead
2 months ago
The Regulatory Strategy Senior Manager will be responsible for contributing regional or global regulatory strategy expertise for development programs or marketed products. The Regulatory Strategy Senior Manager will serve as a regional regulatory lead, or in some cases may also be a global regulatory lead, for development and/or commercial product(s) within the Vertex portfolio. This role requires understanding of regulatory affairs frameworks in Europe, and/or International/RoW markets and understanding of drug development, CMC and supply chain regulations.
Key Responsibilities:- Develop and Implement Regulatory Strategy: Leads the development and implementation of regulatory strategy for assigned region as a member of the global regulatory affairs functional team.
- Contribute to Global Regulatory Strategy: Contributes to and may lead global regulatory strategy development for certain programs.
- Regulatory Communications: Responsible for regulatory communications with local health authority; may independently lead regulatory interactions with the health authority.
- Regulatory Guidance: Provides guidance to teams on regulatory requirements for development and approval pathways for assigned region, including potential for expedited pathways.
- Regulatory Submissions: Manages the process for preparation, submission, and approval of regulatory applications within assigned region.
- Strategic Regulatory Input: Provides strategic and technical regulatory input for key product development or registration documents.
- Regulatory Compliance: Ensures compliance of regulatory submissions with current regulations and guidance.
- Regulatory Intelligence: Reviews and evaluates regulatory intelligence and guidance information to continuously inform regulatory strategy in assigned region.
- Relevant Educational Degree: Relevant educational degree.
- Regulatory Knowledge: Knowledge of relevant regulatory frameworks.
- Drug Development Understanding: Good understanding of drug development and related concepts.
- Market Maintenance: Good understanding of requirements and processes to maintain a product on the market; reporting and surveillance.
- Complex Information Assessment: Ability to assess and understand complex scientific information, regulatory precedent, competitive intelligence, and regulatory guidelines and make recommendations based on assessment.
- Problem-Solving Skills: Strong problem-solving skills.
- Communication Skills: Strong written and verbal communication skills to explain difficult information and build alignment.
- Teamwork: Ability to work effectively within a team environment.
- Project Management: Ability to plan, prioritize, and execute work and projects in a systematic and efficient manner.
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