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, 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, and manages compounds through development and throughout the product lifecycle. Develops and implements acceleration strategies and manages projects and reg strategy documentation.

Responsibilities:
- Interface with LRST and AST; lead GRPT to develop global regulatory strategies aligned with applicable regulations.
- Lead cross-functional stakeholders to ensure strategic messaging in global dossiers and responses to Agency requests.
- Accountable for corporate goals; key internal driver of regulatory policy and strategy for assigned products.
- Lead preparation and maintenance of global regulatory product strategies, including risk assessment/mitigation plans and stakeholder communication.
- Act independently under direction of GRS Sr GRL or TA Head; expand TA knowledge; provide coaching/mentoring; may manage direct reports.
- Influence development of regulations/guidance via analysis of legislation, regulations, and guidance.
- Ensure regulatory record-keeping; develop/implement RA policies and procedures as needed.
- Align regulatory strategies with Senior Management; present assessments and recommendations to executive management.
- Make decisions on work processes, operational plans, and schedules; sponsor/chair key initiatives and present outcomes.

Qualifications:
- Bachelor’s degree in life sciences (pharmacy, biology, chemistry, pharmacology) or related.
- Preferred: relevant advanced degree; certification a plus.
- 7+ years regulatory experience; drug development experience in US&C region.
- Proven 5+ years in strategic leadership with strong project management.
- Experience in complex matrix environments; influencing cross-functional teams; interfacing with major government regulatory agencies.
- Strong communication and proactive negotiation; experience developing/implementing successful global regulatory strategies.
- Preferred: 10+ years in pharmaceutical regulatory activities; lead regulatory product strategist in 2+ major regions (e.g., EU/Japan) in addition to US.
- Higher education may compensate for years of experience.