Senior Director, Regulatory Affairs

Location: Los Angeles

Type: Permanent Position

Salary: Competitive

Are you looking to get into the hottest new therapeutic area of CAR-T Immunotherapies against Cancer? My client in the Los Angeles area is looking to hire a new Senior Director, Regulatory Affairs to be a part of this leading company’s regulatory strategy team.

The Senior Director, Regulatory affairs will be responsible for developing and implementing regulatory strategy, planning and preparing for regulatory submissions, and serving as a global regulatory leader for their Oncology portfolio.

Responsibilities:

• Responsible for the development and implementation of regulatory product strategies.
• Identify and mitigate regulatory risks.
• Responsible for FDA, EMA and other national authorities submissions including IND, CTA, BLA, MAA and sure documents are accurate
• Serve as the Global Regulatory Leader (GRL)
• Act as regulatory expert and source of regulatory advice
• Responsible for robust meeting requests, briefing documents, and coordination/ preparation of teams for meetings and interaction with regulatory authorities
• Responds to queries from regulatory authorities
• Lead other regulatory affairs personnel
   

Requirements:

• Advanced degree with 10-12 years' experience in industry related Regulatory Affairs (or BS with 12-14 years' relevant experience)
• Experience preparing regulatory submission documents
• Previous experience with investigational drugs, including late stage development, and marketed products

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