Regulatory Strategy Associate Director
Vertex Pharmaceuticals
August 19, 2026
Remote friendly (Boston, MA)
United States
Corporate Functions
General Summary:
- Oversee development of regional or global regulatory strategy for development programs or marketed products.
- Serve as global (or sometimes regional) regulatory lead for Vertex portfolio development and/or commercial product(s) and contribute to global regulatory strategy for assigned programs.
Responsibilities:
- Lead development and implementation of global regulatory strategy for assigned projects through commercial stages.
- Contribute to and may lead regional regulatory strategy to inform global strategy.
- Lead regulatory communications and interactions with health authorities.
- Advise teams on regulatory requirements, development and approval pathways, including potential expedited pathways.
- Lead/oversee preparation, submission, and approval of regulatory applications.
- Provide strategic and technical regulatory input for product development/registration documents.
- Ensure regulatory submissions comply with current regulations and guidance.
- Review regulatory intelligence to continuously inform regulatory strategy.
- Advise cross-functional teams and senior management on regulatory risks and strategies.
- Act as advisor/coach to mentor team members.
Qualifications & Skills:
- Specialized knowledge of global/regional regulatory affairs frameworks and guidelines, including reporting and surveillance.
- Comprehensive understanding of drug development (clinical trial design, statistics, clinical pharmacology) and product labeling/reporting/surveillance.
- Ability to assess complex scientific/regulatory information, precedent, competitive intelligence, and guidelines to make recommendations.
- Strong problem-solving skills.
- Ability to adopt emerging technologies (including AI-driven tools) and maintain continuous learning.
- Proactive awareness of technology/AI/automation and regulatory environment changes.
- Strong written/verbal communication; ability to lead and work in a team.
- Prior experience with major health authority submissions and interactions is required.
Education & Experience:
- Bachelor’s degree in biology, chemistry, or related field.
- Typically 8 years of relevant pharmaceutical/biotech regulatory affairs experience (or equivalent education/experience).
Pay Range:
- $168,000 - $252,000
- Oversee development of regional or global regulatory strategy for development programs or marketed products.
- Serve as global (or sometimes regional) regulatory lead for Vertex portfolio development and/or commercial product(s) and contribute to global regulatory strategy for assigned programs.
Responsibilities:
- Lead development and implementation of global regulatory strategy for assigned projects through commercial stages.
- Contribute to and may lead regional regulatory strategy to inform global strategy.
- Lead regulatory communications and interactions with health authorities.
- Advise teams on regulatory requirements, development and approval pathways, including potential expedited pathways.
- Lead/oversee preparation, submission, and approval of regulatory applications.
- Provide strategic and technical regulatory input for product development/registration documents.
- Ensure regulatory submissions comply with current regulations and guidance.
- Review regulatory intelligence to continuously inform regulatory strategy.
- Advise cross-functional teams and senior management on regulatory risks and strategies.
- Act as advisor/coach to mentor team members.
Qualifications & Skills:
- Specialized knowledge of global/regional regulatory affairs frameworks and guidelines, including reporting and surveillance.
- Comprehensive understanding of drug development (clinical trial design, statistics, clinical pharmacology) and product labeling/reporting/surveillance.
- Ability to assess complex scientific/regulatory information, precedent, competitive intelligence, and guidelines to make recommendations.
- Strong problem-solving skills.
- Ability to adopt emerging technologies (including AI-driven tools) and maintain continuous learning.
- Proactive awareness of technology/AI/automation and regulatory environment changes.
- Strong written/verbal communication; ability to lead and work in a team.
- Prior experience with major health authority submissions and interactions is required.
Education & Experience:
- Bachelor’s degree in biology, chemistry, or related field.
- Typically 8 years of relevant pharmaceutical/biotech regulatory affairs experience (or equivalent education/experience).
Pay Range:
- $168,000 - $252,000