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). Continually expands TA knowledge and 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. Manages compounds through all phases of development, including post approval and throughout the life cycle of the product. Develops and implements acceleration strategies and manages projects and necessary documentation of regulatory strategies.

Responsibilities
- Interface with LRST and AST; lead GRPT to develop global strategies aligned with regulations to meet business objectives.
- Lead cross-functional regulatory teams to ensure strategic messaging in global dossiers and responses to Agency requests.
- Accountable for corporate goals; key internal driver of regulatory policy and strategy.
- Lead preparation and maintenance of global regulatory product strategies, including risk assessment/mitigation and communication to stakeholders.
- Independently act under direction; expand TA knowledge; coach/mentor; may manage direct reports.
- Influence development of regulations/guidance through analysis and worldwide accountability.
- Follow and may develop regulatory recordkeeping policies/procedures; ensure compliance.
- Align regulatory strategies with senior management; present recommendations; proactively inform stakeholders of issues/labeling outcomes/risks and mitigations.
- Make decisions on work processes and schedules to achieve program objectives.
- Follow budgets; manage resourcing; chair/sponsor key initiatives; present outcomes to RA LT.

Qualifications
- Required Education: Bachelor’s degree in life sciences (pharmacy, biology, chemistry, pharmacology) or related.
- Preferred Education: relevant advanced degree; certification a plus.
- Required Experience: 7+ years regulatory experience; drug development experience in US&C; 5+ years in strategic leadership with strong project management; experience in matrix environments with multiple stakeholders; communication and proactive negotiation; experience developing/implementing global regulatory strategies.
- Preferred Experience: 10+ years pharmaceutical regulatory activities; lead regulatory product strategist in 2+ major regions (e.g., EU/Japan) plus US; strong global drug development foundation with business acumen.