Associate Director, Regulatory Affairs

Location: San Francisco or Remote

Type: Full-time Position

Salary: Excellent salary, bonus and accompanying benefits package

Great opportunity to grow into an Associate Director, Regulatory Affairs/Regulatory Lead position with a small, international Biotech company specializing in Oncology and Rare Disease treatments. Opportunity to manage all Regulatory resources and be the Regulatory point of contact.

Scope:

The Associate Director, Regulatory Affairs will report directly into the SVP, Regulatory Affairs, who is a seasoned expert with over 30 years of experience in the industry. This professional will provide strategic input on global regulatory strategy, lead preparation of submissions, and act as the primary contact with the FDA and other health authorities.

Responsibilities:

• Develop and execute global regulatory strategies to support development of biologics and/or small molecules
• Manages interactions with Regulatory consultants and contract research organizations
• Ensure compliance with regulatory procedures and work practices; support processes by which regulatory submissions are reviewed, finalized, and signed-off
• Identify issues and execute regulatory strategies to alleviate risks
• Oversee and monitor queries from health authorities
• Work with subject matter experts to respond to queries, and present status updates regarding unfulfilled conditions/commitments
• Maintain a strong knowledge of regulatory requirements and guidelines and act as Regulatory expert

Qualifications:

• Bachelor’s degree in Life Sciences discipline, advanced degree preferred
• 4-6 years of experience in Regulatory Affairs
• Knowledge of FDA/ICH regulations and guidelines
• Biologics/Antibody experience preferred but not 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