Senior Director, Regulatory Affairs Strategy

Job Description

Take the lead in shaping and implementing cutting-edge global regulatory strategies to accelerate development, enhance success rates, and minimize regulatory risks in assigned projects. Act as a key regulatory strategist for intricate, high-priority programs, assuming responsibility for overall regulatory direction and results. Proactively anticipate and tackle regulatory challenges, translating external trends and guidance into practical strategies. Ensure program strategies align with broader portfolio and corporate objectives. Spearhead and actively participate in discussions with regulatory bodies, including preparing briefing documents, planning meetings, devising negotiation tactics, and managing follow-up actions. Offer strategic insights and direction for addressing regulatory inquiries, information requests, and post-meeting commitments. Serve as the primary regulatory liaison on interdisciplinary development teams, influencing decisions across R&D, Clinical, CMC, Quality, Pharmacovigilance, and Commercial functions. Clearly convey regulatory risks, opportunities, and recommendations to senior leadership and stakeholders. Represent Regulatory Affairs Strategy on various governance forums and committees. Provide leadership to Regulatory Strategy personnel, offering coaching, mentoring, and fostering the growth of future regulatory leaders. Support performance management, talent assessment, and succession planning. Cultivate a culture of accountability, collaboration, and continuous improvement within the Regulatory Affairs organization. Oversee the planning, preparation, and review of high-quality global regulatory submissions, ensuring strategic alignment, internal consistency, and adherence to established timelines. Manage external consultants and vendors to ensure efficient and high-quality project outcomes.

Qualifications

1. Bachelor's degree in a scientific field is essential, with a preference for an advanced degree (Master's or PhD). 2. A minimum of 12–15+ years of regulatory experience within the biopharmaceutical sector, demonstrating increasing levels of responsibility. 3. Extensive experience in creating and executing global regulatory strategies for biologics, particularly in clinical development and marketing applications. 4. Proven leadership in interactions with health authorities, including the FDA and major international agencies. 5. Thorough understanding of global regulatory standards, guidelines, and procedures (FDA, EMA, ICH, etc.). 6. Experience in leading or contributing to INDs and BLAs, with MAA experience being advantageous. 7. Demonstrated ability to think strategically while maintaining a hands-on approach. 8. Exceptional written and verbal communication skills, with the capacity to influence senior leaders and cross-functional teams. 9. Experience in mentoring and developing regulatory professionals in a fast-paced environment. 10. Comfort in navigating ambiguity and shifting priorities within a high-growth biotech environment.

Benefits

- Comprehensive medical, dental, and vision coverage, along with 401k options. - Unlimited paid time off. - Parental leave options.