Associate Director/Director, Regulatory Affairs
201 Haskins Way South San Francisco, CA 94080 US
We are a stealth mode, venture-backed biotechnology company focused on transforming the lives of patients with serious and life-threatening rare diseases. We have built a team with significant scientific, clinical/ regulatory, and commercial experience that has a demonstrated track record of success in discovering and developing novel medicines for patients with rare diseases. We pride ourselves on our collective passion to bring innovative therapies to the clinic and are committed to patients for whom no or limited treatment options exist.
We seek an enthusiastic and experienced Associate Director/Director, Regulatory Affairs to provide strategic and operational regulatory leadership in support of our development programs. This includes ensuring timely preparation, review and submission of documents to regulatory authorities, and maintaining compliance with applicable regulatory requirements. This person represents the regulatory function on multi-disciplinary teams and must integrate company goals into the objectives and activities of the Regulatory Affairs Department. The successful candidate will serve as a resource to team members for the regulatory requirements to conduct drug development activities for monoclonal antibody-based products.
- Prepare, review, and submit regulatory documents to authorities
- Manage regulatory consultants
- Guide internal employees on creation of regulatory documents
- Ensure accuracy of regulatory documents
- Risk assessment and mitigation of regulatory compliance
- Provide input into global strategy involving clinical and commercial objectives
- Support the drug development strategy
- Plan and implement lifecycle management regulatory activities (e.g Annual reports, label and CMC changes).
- Prepare and submit regulatory compliant product labeling
- Interact directly and/or indirectly with US and ex-US Health Authorities
- Act as the primary contact with Regulatory Agencies
- Monitor changes in regulatory requirements and emergence of new regulations
- Prepare meeting requests, briefing documents
- Coordinate and prepare teams for meetings
- Provide routine status updates to management
- BS/BA minimum. Advanced degree preferred.
- 5+ years in regulatory affairs (including a minimum of 2 years in leadership)
- Assisting in a major regulatory application (I.e., IND, NDA, BLA, MAA, JNDA, etc.)
- Managing regulatory affairs submissions, preferably for biologics
- Global regulatory affairs experience
- Maintaining ongoing relationship with the FDA or another regulatory authority (EMA, etc.)