Director, RA Global Regulatory Strategy

Responsibilities:
- Develop and implement global regulatory strategies to secure/maintain market approval for assigned therapeutic area products; lead Global Regulatory Product Team (GRPT) and may lead Labeling Regulatory Strategy Team (LRST).
- Lead cross-functional regulatory efforts to ensure clear strategic messaging in global dossiers and agency responses.
- Lead global regulatory product strategy development; drive risk assessment and mitigation strategy; communicate plans to stakeholders.
- Serve as primary regulatory interface with AST and supporting teams; proactively anticipate/mitigate regulatory risks and ensure compliance with global requirements.
- Manage compounds through development and post-approval lifecycle; influence regulations/guidance by analyzing legislation and providing organization-wide impact analysis.
- Maintain regulatory recordkeeping policies; align strategies with senior management; present regulatory assessments/recommendations to executives.
- Make decisions on work processes/operational plans; chair/sponsor key GRS initiatives; monitor budgets/resourcing.

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

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