Job Details

Associate Director Regulatory Affairs CMC

Associate Director Regulatory Affairs CMC

1 day ago Be among the first 25 applicants

This range is provided by Meet Life Sciences. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.

Base pay range

$190,000.00/yr - $240,000.00/yr

Additional compensation types

Annual Bonus and Stock options

Direct message the job poster from Meet Life Sciences

Associate Director / Director, Regulatory Affairs – CMC

Bay Area, CA | Hybrid (3 days onsite per week)

We are partnering with a rapidly growing, pre-IPO biotechnology company advancing first-in-class therapies in oncology and autoimmune diseases. The team is looking for an experienced Associate Director / Director of Regulatory Affairs – CMC to play a critical role in shaping and executing regulatory strategies across early-stage programs.

This is an opportunity to join a collaborative biotech environment where you'll work closely with senior leadership, contribute to the development of regulatory plans, and drive cross-functional alignment on CMC and broader regulatory strategies.

Key Responsibilities

• Provide strategic and operational regulatory input, partnering closely with cross-functional teams to ensure alignment on CMC and overall development plans.
• Contribute to global regulatory strategies, including pre-IND/IND/CTA submissions, risk assessments, and mitigation planning.
• Lead early-stage regulatory activities with a strong focus on CMC-related aspects while also acting as a regulatory generalist across nonclinical and clinical.
• Serve as the regulatory representative on project teams, offering guidance, solutions, and support to enable timely development milestones.
• Draft, review, and finalize regulatory submissions (IND/CTA, NDA/BLA/MAA), ensuring compliance with global health authority requirements.
• Oversee regulatory input on manufacturing process changes, change control, and global filings.
• Lead the preparation of responses to regulatory authority queries and participate in meetings with FDA and other global agencies.
• Stay current on evolving regulatory requirements and communicate updates across internal teams.

Qualifications

• Degree in life sciences, chemistry, chemical engineering, or a related discipline (advanced degree preferred).
• 8-10+ years of regulatory affairs experience in the biotech/pharma industry, ideally within a dynamic, fast-paced company (preferably biologics, open to small molecule)
• Strong track record of successful regulatory submissions and product approvals, with expertise in FDA, ICH, and EMA requirements (UK/EU experience a plus).
• Exceptional communication, leadership, and interpersonal skills with the ability to engage across all levels of the organization.

Apply for full company information and job description!

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Full-time

Job function

• Job function

  Research, Science, and Management

• Industries

  Pharmaceutical Manufacturing and Biotechnology Research

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