Role
Executive Director / Senior Director of Regulatory Affairs
Bay Area Hybrid
Company Description
This biotechnology company is dedicated to developing innovative therapies for neurodegenerative diseases and autoimmune disorders, with a particular focus on conditions such as Alzheimer’s and Huntington’s disease.
The senior leadership emphasizes the company’s core values daily, highlighting the importance of resilience and commitment to patients and their families.
Following the successful Phase 3 trial results, the company anticipates significant growth in the near future.
Role Description
This role leads global regulatory efforts to help develop and manage innovative programs at Annexon. Responsibilities include creating strategies to meet company goals, participating in core team meetings, and managing communication with regulatory agencies.
The Executive Director / Senior Director of Regulatory Affairs will also oversee the preparation of all regulatory documents and submissions, mentor junior team members, and stay updated on changes in FDA and EU regulations.
This will be an individual contributor role to start, with expected direct reports in the future.
Qualifications :
Bachelor’s Degree in a Life Sciences sector. Advanced degree preferred but not required.
15+ years of Regulatory Affairs experience in a pharma / biotech setting.
Rare Disease experience required; Neurology and / or Ophthalmology experience desired
Expertise in IND / CTA, and BLA / MAA submissions, with strong knowledge of FDA and EU regulations.
Previous experience in a small company setting
If you or someone you know is interested in the Executive Director / Senior Director of Regulatory Affairs position, please message me at [email protected]
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