Regulatory Strategy Director
Vertex Pharmaceuticals
9 hours ago
Remote friendly (Boston, MA)
United States
Corporate Functions
General Summary:
The Regulatory Strategy Director will develop and implement global/regional regulatory strategies for assigned projects within the Vertex portfolio.
Key Duties And Responsibilities:
- Lead development of regulatory strategy for assigned projects/regions (from first-in-human through post-marketing application) per Global Regulatory Strategy Documents.
- Represent GRA on core development and project teams; collaborate with regional leaders to ensure unified regulatory input into clinical programs and commercial strategy.
- Address complex issues with innovative regulatory solutions; align cross-functional communications with GRA teams and leadership.
- Anticipate global regulatory changes and develop proactive strategy.
- Shape regulatory strategy for submission documents and Health Authority communications.
- Counsel GRA leadership on status of global Regulatory Affairs strategies and tactics, procedures, and practices.
- Ensure strategies align with business objectives and comply with current regulations and guidance.
- Manage project plans/timelines to ensure prioritization and on-time goals.
- Contribute to continuous improvement of department processes/strategies.
- Provide regulatory leadership for GRA functional teams/projects with moderate resource requirements or complexity.
Knowledge And Skills:
- Experienced in Regulatory Affairs strategy in assigned geographic region; direct stakeholder interactions.
- Advanced regulatory affairs science knowledge, including global/regional/local legislation and guidance for human pharmaceutical development.
- Proficient in R&D, preclinical/clinical requirements for drug development, registration, and maintenance.
- Ability to analyze/interpret data, protocols, safety reporting, labeling, and phase-related activities.
- Advanced skill in proposing regulatory paths/clinical plans; guide teams based on regulatory outcomes; lead productive health authority interactions.
- Coaches and mentors others.
- Collaborative; builds consensus; clear, compelling communication and influence.
Education And Experience:
- Bachelor’s degree in Biology, Chemistry, or related discipline.
- Typically 10 years relevant pharmaceutical/biotech regulatory affairs experience (or equivalent combination).
Pay Range:
- $196,800 - $295,200
The Regulatory Strategy Director will develop and implement global/regional regulatory strategies for assigned projects within the Vertex portfolio.
Key Duties And Responsibilities:
- Lead development of regulatory strategy for assigned projects/regions (from first-in-human through post-marketing application) per Global Regulatory Strategy Documents.
- Represent GRA on core development and project teams; collaborate with regional leaders to ensure unified regulatory input into clinical programs and commercial strategy.
- Address complex issues with innovative regulatory solutions; align cross-functional communications with GRA teams and leadership.
- Anticipate global regulatory changes and develop proactive strategy.
- Shape regulatory strategy for submission documents and Health Authority communications.
- Counsel GRA leadership on status of global Regulatory Affairs strategies and tactics, procedures, and practices.
- Ensure strategies align with business objectives and comply with current regulations and guidance.
- Manage project plans/timelines to ensure prioritization and on-time goals.
- Contribute to continuous improvement of department processes/strategies.
- Provide regulatory leadership for GRA functional teams/projects with moderate resource requirements or complexity.
Knowledge And Skills:
- Experienced in Regulatory Affairs strategy in assigned geographic region; direct stakeholder interactions.
- Advanced regulatory affairs science knowledge, including global/regional/local legislation and guidance for human pharmaceutical development.
- Proficient in R&D, preclinical/clinical requirements for drug development, registration, and maintenance.
- Ability to analyze/interpret data, protocols, safety reporting, labeling, and phase-related activities.
- Advanced skill in proposing regulatory paths/clinical plans; guide teams based on regulatory outcomes; lead productive health authority interactions.
- Coaches and mentors others.
- Collaborative; builds consensus; clear, compelling communication and influence.
Education And Experience:
- Bachelor’s degree in Biology, Chemistry, or related discipline.
- Typically 10 years relevant pharmaceutical/biotech regulatory affairs experience (or equivalent combination).
Pay Range:
- $196,800 - $295,200