This highly dynamic team is seeking an entrepreneurial and strategic Senior Director/ Director, Regulatory Affairs to play a key role on our cross-functional R&D team. In this role, you will have the opportunity to lead and contribute to regulatory strategies that expedite development, maximize the probability of success, and mitigate risks. The individual in this position will have the unique opportunity to shape the Regulatory function of a rapid-growth biotech startup.
- Lead and contribute to regulatory strategies that expedite development, maximize the probability of success, and mitigate risks. Ensure global regulatory requirements and strategy are understood by project teams.
- Play a hands-on role in planning, preparing, and coordinating regulatory documents for submission to global health authorities in support of regulatory filings, such as INDs, BLAs, MAAs, CTAs/IMPDs, amendments, annual updates, briefing documents, and responses to Agency queries.
- Close collaboration with internal and external cross-functional team members to ensure achievement of submissions and timely approvals of applications
- Lead interactions with FDA and other Health Authorities.
- Communicate project updates and risks to senior management and stakeholders across the organization. Track regulatory commitments, deliverables, and overall project timelines.
- Maintain up-to-date knowledge and understanding of global regulatory requirements.
- Initiate and contribute to the development of policies and procedures in alignment with GxPs, global regulatory requirements and guidance, and corporate objectives.
- Provide hands-on leadership to cross-functional teams in planning, preparing, and coordinating documents for submission to global authorities in support of regulatory filings, such as INDs, BLAs, MAAs, CTAs/IMPDs, amendments, annual updates, briefing documents, and responses to Agency queries.
- Lead and contribute to regulatory strategies that expedite development, maximize the probability of success, and mitigate risks.
- Communicate project updates and risks to senior management and stakeholders across the organization. Track regulatory commitments and deliverables. Interact efficiently and independently with consultants.
- Bachelor’s degree in a relevant scientific discipline and/or information technology. Advanced degree preferred
- 10-12 years of biopharmaceutical experience, which includes at least 8-10 years of direct experience in Regulatory Affairs
- Experience in biologics drug development, parenteral products, including combination products, orphan/rare disease product development
- Experience in regulatory scenario planning, and developing and implementing regulatory strategies in a global environment.
- Comprehensive understanding of applicable global regulations, guidance, and practices
- Demonstrated hands-on experience in the planning, preparation, and submission of global regulatory documents including clinical trial applications and maintenance (IND/CTA), NDA/BLA/MAA, regulatory briefing documents, and agency queries
- Prior experience leading interactions with FDA and other global regulatory authorities
- Strategic and analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines
- Works collaboratively and efficiently with multiple functional areas in a fast-paced matrixed team environment, including functional team members, company management, and external vendors and contract organizations
- Strong team and project management skills
- Strong verbal and written communication skills; ability to clearly articulate regulatory viewpoints to diverse internal and external audiences including executive leadership
- Ability to thrive in a collaborative and fast-paced environment
Specialized knowledge, Licenses, etc.:
- Results-oriented individuals with a strong work ethic and ability to complete projects with minimal oversight
- Knowledge of GxP, ICH, FDA, EMA and other global regulations and guidances
- Attention-to-detail and an ability to balance analytical and critical-thinking skills to develop data-driven, strategically oriented regulatory proposals and documents
- Experience developing regulatory strategies for biologics and/or rare disease development programs
- Preferred location is Immunovant's NYC or Durham office; remote considered
- Dynamic, interactive, fast-paced, and entrepreneurial environment
- Domestic or international travel is required (~10%)