This clinical-stage biopharmaceutical company is developing life-saving medicines for patients with rare respiratory diseases. They are seeking a Head of Global Regulatory Affairs (Executive Director or VP) who can develop and execute upon regulatory strategies to advance their pipeline toward commercialization. Reporting into the CMO, this individual will establish the Regulatory function for the company and work directly with health authorities. This position can be completely remote with some occasional travel to their headquarters in North Carolina. With their lead candidate in Phase 2B, now is an exciting time to join this growing, R&D-driven organization and help to get innovative therapies approved!
- Serve as global regulatory head, providing regulatory guidance and strategy, and assessing regulatory risk for the company.
- Lead the development and execution of all clinical, non-clinical, and commercial regulatory strategies for a portfolio of respiratory programs.
- Manage and lead US and global submissions (INDs, CTAs, NDAs, etc.) including authorship of critical documents as needed.
- Lead and represent the company in regulatory health authority meetings. Lead the preparation of meeting documents, meeting requests, meeting packages, etc.
- Assess regulatory project plans and timelines and ensure all projects are appropriately prioritized and key goals are met on time.
- Plan, execute, and lead the coordination and preparation of teams for health authority meetings.
- Oversee compilation, electronic processing, and publishing to ensure high quality and timely electronic submissions compliant with regulatory authority requirements.
- Serve as primary company representative to regulatory agencies to ensure the review and approval of development plans, the timely resolution of issues, and the approval of marketing applications.
- Advise senior leadership and project teams on status of US and global regulatory affairs strategies and tactics, procedures and practices and impact on the development and approval requirements.
- Oversee the maintenance and creation of relevant SOPs, Work Instructions, and other necessary guidance.
- Support department budget and ensure operations are within the approved budget and timeline.
- Provide leadership and direction to staff, consultants, and vendors supporting regulatory affairs.
Qualifications and Background:
- Bachelor’s degree in a scientific field required. Advanced degree (MS, PhD, Pharm D) preferred.
- Ten or more years of experience in global Regulatory Affairs for pharmaceutical drugs and/or biologics.
- Must have experience with pulmonary/respiratory programs. Experience with Pulmonary Arterial Hypertension highly desired.
- Successful track record of filing Marketing Applications (NDA, MAA, BLA, etc) along with briefing packages, orphan drug applications, and various other regulatory documents.
- Experience with biologics or combination products a plus.
- Strong knowledge of biopharmaceutical industry Regulatory Affairs throughout the product lifecycle, including Development, CMC, Labeling, Promotion, Commercialization, and Operations.
- Must have strong Regulatory experience with US FDA and also outside the US (EMA, Asia, etc)
- Positive attitude and willing to roll up your sleeves to get the job done; ability to pay close attention to detail and step back and think strategically.
- Strong interpersonal verbal, written and presentation skills in communication with internal and external parties.
- Demonstrated success hiring, leading and scaling teams desired, but not required.
- Must be comfortable working for a small organization, and able to handle ambiguity.