The Regulatory Strategy Associate Director will be responsible for overseeing the development of regional or global regulatory strategy for development programs or marketed products. This role will serve as a global regulatory lead, or in some cases a regional regulatory lead, for development and/or commercial product(s) within the Vertex portfolio and contribute to the global regulatory strategy for the assigned program(s).
This role requires advanced understanding of regulatory affairs frameworks in the US, Europe, or other international markets, drug development, and related concepts, and the ability to translate this knowledge into effective regulatory planning and strategy development.
- Lead the development and implementation of global regulatory strategy for assigned projects in development through commercial stages
- Contributes to and may lead the development and implementation of regional regulatory strategy to inform the global strategy for certain projects
- Leads regulatory communications and interactions with health authorities
- Advises teams on regulatory requirements for development and approval pathways, including potential for expedited pathways
- Leads and oversees the process for preparation, submission, and approval of regulatory applications
- Provides strategic and technical regulatory input for key product development or registration documents
- Ensures compliance of regulatory submissions with current regulations and guidance
- Reviews and evaluates regulatory intelligence and guidance information to continuously inform regulatory strategy
- Advises cross-functional teams and senior management on regulatory risks, considerations, and strategies for program(s)
- Acts as an advisor and coach to mentor members of the team
- Specialized knowledge of global and regional regulatory affairs frameworks and guidelines Understanding of requirements and processes to maintain a product on the market; reporting and surveillance
- Comprehensive understanding of drug development and related concepts, such as clinical trial design, statistics, and clinical pharmacology
- Comprehensive understanding of requirements and processes to maintain a product on the market, product labeling, reporting, and surveillance
- Ability to assess and understand complex scientific information, regulatory precedent, competitive intelligence, and regulatory guidelines and make recommendations based on assessment
- Strong problem-solving skills
- Demonstrates the ability to effectively adopt and leverage emerging technologies, including AI-driven tools, and maintains a continuous learning mindset to strengthen regulatory strategy, decision-making, and operational efficiency.
- Proactively remains up to date on advances with technology, AI, automation, competitive intelligence and changes in the regulatory environment.
- Strong written and verbal communication skills, tailored to multiple audiences, to communicate difficult concepts and persuade others to adopt a different point of view
- Ability to effectively lead and work within a team environment
- Prior experience with major health authority submissions and health authority interactions is required.
- Bachelor's degree in biology, Chemistry, or other related discipline
- Typically requires 8 years of relevant pharmaceutical or biotech industry experience within regulatory affairs, or the equivalent combination of education and experience