Director, RA Global Regulatory Strategy

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). Ensures strategic messaging and content of global regulatory dossiers; 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 phases and the product lifecycle.

Responsibilities:
- Interface with LRST and AST to lead cross-functional objectives; lead GRPT to develop global regulatory strategies aligned with regulations.
- Lead cross-functional stakeholders to ensure clear strategic messaging in dossiers and Agency responses.
- Drive regulatory policy and strategy; lead preparation and maintenance of global regulatory product strategies and risk assessment/mitigation plans.
- Act independently under GRS Sr GRL or TA Head; expand TA knowledge; coach/mentor GRPT; may manage direct reports.
- Analyze regulations/guidance and provide organization-wide accountability for assigned products.
- Ensure regulatory recordkeeping compliance and may develop RA policies/procedures.
- Present regulatory assessments/recommendations to executive management; inform stakeholders of risks, labeling outcomes, and mitigations.
- Make decisions on work processes/operational plans; manage budget allocations and resourcing; chair/sponsor key initiatives and present outcomes.

Qualifications:
- Required: Bachelor’s degree in life sciences or related field; 7+ years regulatory experience; drug development experience in US&C; 5+ years strategic leadership with strong project management; matrix experience; strong communication and proactive negotiation; global regulatory strategy experience.
- Preferred: Relevant advanced degree; certification a plus; 10+ years pharmaceutical regulatory experience; lead regulatory product strategist in 2+ major regions (e.g., EU/Japan) plus US; strong global drug development foundation and business acumen.

Benefits (as stated): Paid time off; medical/dental/vision insurance; 401(k) for eligible employees; eligible for long-term incentive programs.