What are the responsibilities and job description for the Director of Regulatory Affairs position at Medella Life?
I am currently partnering with a growing, innovation-driven pharmaceutical company to appoint a Director/Senior Director of Regulatory Affairs. This is a fully remote, U.S.-based opportunity offering a key leadership role within a dynamic and expanding organisation.
About the Role
The Director of Regulatory Affairs will lead regulatory strategy and execution across development programs, working closely with senior leadership and cross-functional teams. This individual will play a critical role in guiding products through the regulatory pathway toward approval and commercialization.
Key Responsibilities
- Develop and implement global regulatory strategies aligned with business objectives and development timelines
- Lead the preparation, review, and submission of INDs, NDAs, BLAs, MAAs, and other regulatory filings
- Support primary liaison with the FDA and other health authorities, including leading meetings (pre-IND, end-of-Phase II, pre-NDA)
- Provide strategic regulatory input into clinical development plans, study designs, and endpoints
- Interpret regulatory guidelines and communicate risks, opportunities, and mitigation strategies to senior leadership
- Ensure compliance with all applicable regulatory requirements, including FDA, ICH, and GxP standards
- Oversee regulatory labelling strategy, including negotiation with health authorities
- Support due diligence activities, partnerships, and licensing opportunities from a regulatory perspective
- Collaborate cross-functionally with clinical, quality, CMC, and commercial teams to align regulatory strategy
- Manage regulatory timelines and deliverables to ensure alignment with overall program milestones
- Build, lead, and mentor the regulatory affairs function, including external consultants and vendors where applicable
- Stay current with evolving regulatory landscapes and proactively assess impact on development programs
Candidate Profile
- Bachelor’s degree required; advanced degree (PhD, PharmD, or MS) preferred
- 10 years of regulatory affairs experience within pharma or biotech
- Proven track record of successful FDA submissions and approvals
- Strong knowledge of U.S. regulatory frameworks; global experience advantageous
- Demonstrated leadership and ability to operate in a fast-paced environment
- Prior experience within a small or mid-sized company is highly desirable
- Willing to travel up to 30% domestically
Opportunity Highlights
- Fully remote role (U.S.-based)
- High-impact position within a growing company
- Competitive compensation package including bonus and equity
- Collaborative, forward-thinking leadership team