Job

Senior Director Regulatory Affairs

Location: San Francisco, CA 

**also have similar roles in San Diego

Type: Full Time Permanent

Salary: Excellent salary, bonus and accompanying benefits package (Relocation provided for exceptional candidates)

Exciting opportunity as a Senior Director, Regulatory Affairs to manage all regulatory activities for new Oncology development programs from pre-IND through BLA/NDA and post approvals.

SCOPE:

This person will be responsible for developing the global regulatory strategy (clinical, non-clinical and CMC disciplines) through successful approval of the Oncology drugs in development. My client is looking for a professional who will be able to ensure submissions to regulatory health authorities are complete and up to company standards. This professional will also be responsible prepartion for all health authority interctions.

RESPONSIBILITIES:

• Represent Regulatory Affairs in cross-functional teams and manage clinical development program planning
• Able to criticall assess nonclinical, chemistry, manufacturing and controls, and clinical trial related documentation. 
• Lead the regulatory team in the managing, planning, coordinating and preparing all documentation submitted to Health Authorities
• Contribute to the implementation of processes improvements
• Manage all regulatory agency and health authority interactions
• Manage regulatory team through promotions

EDUCATION/EXPERIENCE:

• Bachelors Degree required (Masters, PharmD, or PhD preferred)
• 10-12 years of Regulatory Affairs experience within the biopharma industry
• Oncology experience required
• Previous management experience preferred

SKILLS:

• Previous experience working with the FDA and knowledge of US and international regulatory requirements
• Relevant submission filing/approval experience (INDs/CTAs/NDAs/BLAs) in leading negotiations with global health authroirities

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