Director, RA Global Regulatory Strategy
AbbVie
July 01, 2026
Remote friendly (Waltham, MA)
United States
$182,000 - $346,000 USD yearly
Corporate Functions
Job Description
The Director Regulatory Affairs Global Regulatory Lead (GRL II), Global Regulatory Strategy, is responsible for developing and implementing global strategies to secure and maintain market approval for product(s) in the assigned therapeutic area. Leads the Global Regulatory Product Team (GRPT). May lead the Labeling Regulatory Strategy Team (LRST). Serves as the primary regulatory interface with AST and supporting teams, proactively anticipates and mitigates regulatory risks, ensures compliance with global regulatory requirements, and manages compounds through all development and post-approval lifecycle phases. Develops and implements acceleration strategies and manages regulatory strategy projects and documentation.
Responsibilities
- Interface with LRST and AST; lead GRPT to develop global regulatory strategies aligned with regulations and business objectives.
- Lead cross-functional regulatory stakeholders to ensure strategic messaging in global dossiers and agency responses.
- Accountable for corporate goals; regulatory policy and strategy driver for assigned products.
- Lead preparation and maintenance of global regulatory product strategies, including risk assessment/mitigation plans and stakeholder communication.
- Independently operate under direction of senior leadership; expand therapeutic area knowledge; coach/mentor GRPT members.
- Influence regulations/guidance by analyzing legislation and providing organizational recommendations.
- Ensure regulatory recordkeeping compliance and may develop RA policies/procedures.
- Align global regulatory strategies with senior management; present assessments/recommendations and communicate risks/labeling outcomes.
- Make decisions on work processes/operational plans; manage budgets/resourcing and sponsor key GRS initiatives.
Qualifications
- Required: Bachelor’s degree in life sciences (pharmacy, biology, chemistry, pharmacology) or related.
- Preferred: Advanced degree; certification a plus.
- Required: 7+ years regulatory experience; US&C drug development experience; 5+ years strategic leadership with strong project management; matrix experience and stakeholder influence; strong communication and proactive negotiation; experience developing/implementing global regulatory strategies.
- Preferred: 10+ years pharmaceutical regulatory experience; lead regulatory product strategist in 2+ major regions (e.g., EU/Japan) in addition to US; strong global drug development foundation and business acumen.
The Director Regulatory Affairs Global Regulatory Lead (GRL II), Global Regulatory Strategy, is responsible for developing and implementing global strategies to secure and maintain market approval for product(s) in the assigned therapeutic area. Leads the Global Regulatory Product Team (GRPT). May lead the Labeling Regulatory Strategy Team (LRST). Serves as the primary regulatory interface with AST and supporting teams, proactively anticipates and mitigates regulatory risks, ensures compliance with global regulatory requirements, and manages compounds through all development and post-approval lifecycle phases. Develops and implements acceleration strategies and manages regulatory strategy projects and documentation.
Responsibilities
- Interface with LRST and AST; lead GRPT to develop global regulatory strategies aligned with regulations and business objectives.
- Lead cross-functional regulatory stakeholders to ensure strategic messaging in global dossiers and agency responses.
- Accountable for corporate goals; regulatory policy and strategy driver for assigned products.
- Lead preparation and maintenance of global regulatory product strategies, including risk assessment/mitigation plans and stakeholder communication.
- Independently operate under direction of senior leadership; expand therapeutic area knowledge; coach/mentor GRPT members.
- Influence regulations/guidance by analyzing legislation and providing organizational recommendations.
- Ensure regulatory recordkeeping compliance and may develop RA policies/procedures.
- Align global regulatory strategies with senior management; present assessments/recommendations and communicate risks/labeling outcomes.
- Make decisions on work processes/operational plans; manage budgets/resourcing and sponsor key GRS initiatives.
Qualifications
- Required: Bachelor’s degree in life sciences (pharmacy, biology, chemistry, pharmacology) or related.
- Preferred: Advanced degree; certification a plus.
- Required: 7+ years regulatory experience; US&C drug development experience; 5+ years strategic leadership with strong project management; matrix experience and stakeholder influence; strong communication and proactive negotiation; experience developing/implementing global regulatory strategies.
- Preferred: 10+ years pharmaceutical regulatory experience; lead regulatory product strategist in 2+ major regions (e.g., EU/Japan) in addition to US; strong global drug development foundation and business acumen.