Director, RA Global Regulatory Strategy

Director Regulatory Affairs Global Regulatory Lead (GRL II), Global Regulatory Strategy

Responsibilities:
- Develop and implement global regulatory strategies to secure and maintain market approval for products in the assigned therapeutic area.
- Lead the Global Regulatory Product Team (GRPT); may lead the Labeling Regulatory Strategy Team (LRST).
- Ensure strategic messaging/content of global regulatory dossiers and responses to regulatory agency requests.
- Serve as primary regulatory interface with AST and supporting teams; proactively anticipate and mitigate regulatory risks.
- Ensure compliance with global regulatory requirements across all development phases, including post-approval through product lifecycle.
- Lead global regulatory product strategy preparation; maintain risk assessment/mitigation strategies and communicate plans to stakeholders.
- Influence development of regulations and guidance; analyze legislation/regulations/guidance and provide organizational analysis.
- Ensure alignment of regulatory strategies with senior management; provide recommendations/assessments to executive management.
- Manage work processes/operational plans; chair/sponsor key initiatives and present outcomes.

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

Benefits:
- Paid time off (vacation, holidays, sick), medical/dental/vision insurance, 401(k) (eligible employees).

Application Instructions:
- None provided.