Senior Manager, Regulatory Affairs 

Location: Los Angeles, CA

Type: Permanent Position 

Salary: Competitive

Are you a Manager or Senior Manager looking to take the next step of your career and be given the opportunity to join one of the Leading CAR-T companies in country? My client in theLos Angeles area is looking for a candidate at this level to join their growing team.

The Senior Manager, Regulatory Affairs will be the US lead in providing strategic input from IND to Launch. They will also be responsible for participating in cross functional teams and managing US based regulatory submissions.

Responsibilities: 

• Ensure development of assigned products from IND stage to launch according to necessary timelines
• Critically review technical documents 
• Prepare and manage the preparation of US-based regulatory documents
• Ensure that documents to be submitted to the health authorities are compliant with US eCTD submission requirements.
• Mentor Junior Regulatory staff
• Ensure regulatory knowledge is maintained 

Requirements: 

• Bacherlor's degree or higher
• 4-6 years of Regulatory Affairs or drug development experience 

I am a Regulatory Affairs market expert working with a large variety of clients across the Biotech and Pharmaceutical industries. If this role isn’t of interest to you, but you’d like to explore other opportunities in the market, please feel free to reach out directly. Contact Nikita Madan at 619-350-6341 or at n.madan@hamlynwilliams.com