Associate Director, Regulatory Affairs 

Location: San Francisco, CA

Type: Permanent Position 

Salary: Competitive

My client in the Bay area is looking to hire a new Associate Director, Regulatory Affairs to work on the Regulatory strategy for their Oncology portfolio.  This large organization is a leader in the Biotech field and is one of the best countries to work for in the country. The Associate Director, Regulatory Affairs will be responsible for preparing and overseeing the preparation of submissions, developing regulatory strategy, and acting as the point of contact for Health Authorities. 

Responsibilities: 

• Prepare and oversee the preparation of regulatory submissions (and labeling and product packaging) through collaboration with other teams including supplements and license renewals to clinical trial applications and marketing authorizations, and original INDs/CTAs and NDAs/MAAs for assigned territories.
• Contributes to local and global process improvements.
• Maintain comprehensive knowledge of regulatory requirements, including ICH requirements and regional requirements including understanding of global and regional regulatory trends and requirements.
• Develop regulatory strategy and manage negotiations with Regulatory Authorities.
• Is seen as a Regulatory expert in order to provide regulatory advice to other departments
• Acts as primary contact with Regulatory Authorities in multiple territories

Requirements: 

• Bachelor's degree or higher biological or physical sciences
• 6-8 years of Regulatory Affairs experience 
• Knowledge of US FDA and international pharmaceutical regulations and drug development processes.
• Previous people management experience is preferred

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