Director, Regulatory Affairs 

Location: San Francisco, CA

Type: Permanent Position 

Salary: Competitive

This leading Biotech in the Bay Area is looking to hire a Director, Regulatory Affairs. This professional will be responsible for overseeing and leading all regulatory activities pertaining to the global regulatory strategy. 

Responsibilities: 

• Acts as point of contact for Regulatory Authorities
• Responsible for leading all regulatory activities for assigned projects including overseeing complex submissions (e.g. supplements, annual reports, responses to request for information, original INDs/CTAs and NDAs/MAAs for assigned territories)
• Oversees preparation of labeling and product packaging (region specific) and ensuring is is in alignment with global Regulatory strategy
• Responsible for implantation of regulatory strategy and management of negotiations with Regulatory Authorities
• Is recognized as an expert resource for Regulatory Advice in other departments

Requirements: 

• Bachelor's degree or higher biological or physical sciences
• 10-12 years of Regulatory Affairs experience 
• Knowledge of US FDA and international pharmaceutical regulations and drug development processes.
• Previous people management experience is required

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