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). 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 the GRPT to develop global strategies aligned with regulations to meet business objectives.
- Lead cross-functional stakeholders to ensure appropriate strategic messaging in global regulatory dossiers and Agency responses.
- Drive regulatory policy and strategy; ensure corporate goals are met.
- Lead preparation and maintenance of global regulatory product strategies and risk assessment/mitigation plans.
- Influence regulation and guidance development; analyze legislation/regulations/guidance.
- Ensure regulatory recordkeeping compliance; develop/implement RA policies/procedures as needed.
- Align strategies with senior management; present assessments/recommendations; proactively inform stakeholders of issues, labeling outcomes, and risks.
- Make decisions on work processes/operational plans to achieve program objectives; lead initiatives in professional/industry groups.
- Follow budget allocations and manage resourcing; chair/sponsor key GRS initiatives and present outcomes.

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 region.
- 5+ years in strategic leadership role with strong project management.
- Experience in complex matrix environments and influencing cross-functional teams.
- Strong communication and proactive negotiation skills; experience developing/implementing global regulatory strategies.
Preferred Experience:
- 10+ years in pharmaceutical regulatory activities; lead regulatory product strategist in 2+ major regions (e.g., EU or Japan) plus US.

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