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 therapeutic area 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 product life cycle. Develops and implements acceleration strategies. Manages projects and necessary documentation of regulatory strategies.

Responsibilities:
- Interface with LRST and AST; lead GRPT to develop global regulatory strategies aligned with applicable regulations.
- Lead cross-functional teams to ensure appropriate strategic messaging in dossiers and responses to agency requests.
- Drive regulatory policy and strategy to meet corporate goals for assigned products.
- Lead preparation/maintenance of risk assessment and mitigation strategies; communicate plans to stakeholders.
- Act independently under direction of senior leadership; expand TA knowledge; coach/mentor GRPT members.
- Analyze legislation/regulations/guidance; provide worldwide accountability for assigned products.
- Ensure regulatory record-keeping compliance; develop RA department policies/procedures as needed.
- Present regulatory assessments/recommendations to executive management; inform stakeholders of issues, outcomes, risks, and mitigations.
- Make decisions on work processes/operational plans to meet program objectives.
- Manage resourcing within budget allocations; chair/sponsor key initiatives and present outcomes.

Qualifications:
- Required: Bachelor’s degree in life sciences (pharmacy, biology, chemistry, pharmacology) or related.
- Preferred: Relevant advanced degree; certification a plus.
- Required: 7+ years regulatory experience; drug development experience in US & Canada; 5+ years strategic leadership with strong project management; experience in complex matrix environments; communication and proactive negotiation; experience developing and implementing global regulatory strategies.
- Preferred: 10+ years in 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.

Benefits:
- Paid time off; medical/dental/vision insurance; 401(k) to eligible employees.

Application instructions:
- Not specified in provided text.