Senior Director of Regulatory Affairs

Location: San Francisco

Type: Full Time Permanent 

Salary: Excellent salary, bonus and accompanying benefits package

Our client is a clinical-stage biopharma company focused on therapies to treat liver disease. They are looking for someone to lead their Regulatory department. This ultimately creates a lot more autonomy within the role and ability to grow a team.  Prior engagement with FDA on combination drug development and applicable experience with submissions to/interactions with the US FDA makes for a strong candidate.

Responsibilities:

·         Lead and implement global regulatory strategy: interactions with regulatory authorities, leading submissions, and contributing to product development strategies

·         Develop regulatory strategies aimed at opportunities that may accelerate drug

·         There will be an emphasis on interactions with the US Food and Drug Administration (US FDA)

·         Directly contribute to regulatory submissions

·         Ensure compliance with health authority regulations

·         Maintain and communicate knowledge of regulatory requirements

·         Maintain up to date information regarding changes to the regulatory environment

Experience:

·         ~5 years of experience as a US regulatory affairs liaison within the pharmaceutical industry

·         Prior experience with IND submissions for small molecules

·         Experience working in cross functional teams

·         Experience leading negotiations with the US FDA 

·         Extensive knowledge of regulatory requirements

·         Experience in authoring and critically reviewing complex technical documents

·         BA/BS Degree in a health/life sciences. Advanced degree preferred

My team and I manage a slew of other full-time and contract positions for large, mid-size, and start up companies across the US (Pharma, Biotech, and Medical Device). If the above role isn’t for you but you’d nevertheless like to discuss your options in the market, I’d welcome a confidential discussion by phone or email. Please feel to reach out directly: (619) 350 - 6195 and/or c.hotz@hamlynwilliams.com