Director of Regulatory Affairs - Chemistry, Manufacturing, and Controls (CMC)
Location: Burlingame, CA
Position Overview:
We are seeking a highly experienced Director of Regulatory Affairs for CMC to oversee and lead regulatory strategies in support of our oncology and immunology therapeutic programs. The Director will ensure that all Chemistry, Manufacturing, and Controls (CMC) regulatory submissions meet global standards and facilitate the successful development, approval, and commercialization of cutting-edge cancer and immunology treatments. This role requires expertise in regulatory guidelines, collaboration with cross-functional teams, and direct interactions with global health authorities.
Key Responsibilities:
Regulatory Strategy Development:
Lead the development and implementation of global CMC regulatory strategies for oncology and immunology therapeutics, including small molecules, biologics and other advanced modalities.
Ensure alignment of CMC regulatory strategies with broader regulatory, clinical, and commercial objectives to support timely development and registration of products.
Provide strategic input during all stages of product development, from early-stage research through post-approval lifecycle management.
CMC Submission Management:
Manage the preparation, review, and submission of high-quality CMC regulatory documents for INDs, CTAs, BLAs, NDAs, and MAAs, as well as post-approval variations.
Ensure CMC sections of regulatory submissions comply with FDA, EMA, ICH guidelines, and other relevant regulatory agency requirements.
Collaborate with cross-functional teams (e.g., Process Development, Quality, Manufacturing, and Clinical) to ensure CMC submissions meet all necessary scientific and regulatory standards.
Health Authority Interactions:
Serve as the primary regulatory contact for CMC-related interactions with global regulatory agencies, including FDA, EMA, and other regulatory bodies.
Lead and participate in regulatory meetings, including pre-IND, pre-BLA/NDA, and scientific advice meetings to resolve CMC issues and ensure alignment with agency expectations.
Develop and maintain strong working relationships with key stakeholders at regulatory agencies.
Regulatory Compliance and Intelligence:
Stay abreast of current global CMC regulatory requirements and trends in cancer and immunology therapeutics to ensure compliance and proactively address potential regulatory challenges.
Provide regulatory intelligence and risk assessments to support product development, manufacturing changes, and post-marketing activities.
Advise internal teams on regulatory expectations and best practices related to drug substance and drug product manufacturing, stability, and quality control.
Qualifications:
Bachelor's degree in a scientific discipline required; advanced degree (PhD, PharmD, MS) in Chemistry, Biochemistry, Pharmaceutical Sciences, or related field preferred.
10+ years of experience in Regulatory Affairs with a focus on CMC, ideally in oncology and/or immunology therapeutic areas.
Phase 3 and/or commercial experience in regulatory filings.
Extensive experience with global CMC regulatory requirements, including FDA, EMA, and ICH guidelines.
Ability to independently write sections of regulatory filings.
Proven track record of leading CMC regulatory submissions for INDs, NDAs, BLAs, MAAs, and post-approval lifecycle management in oncology or immunology products.
Familiarity with the development and manufacturing of both small molecules and biologics.
Strong understanding of Good Manufacturing Practices (GMP), quality control, and regulatory compliance principles.
Ability to manage multiple complex projects and work effectively in a fast-paced, dynamic environment.
Excellent leadership, team management, and project management skills.
Strong verbal and written communication skills with experience presenting to regulatory authorities and senior management.
Preferred Skills:
Experience with oncology and immunology, small molecules and biologics, including monoclonal antibodies and immune checkpoint inhibitors.
Direct involvement in regulatory meetings, including FDA advisory committees, regulatory strategy meetings, and post-submission negotiations.
This role is essential for driving the regulatory strategy and execution of CMC activities for innovative oncology and immunology treatments. If you have a passion for regulatory science, CMC expertise, and the desire to impact the future of cancer and immunological therapies, we encourage you to apply.
This position is located in Burlingame, CA. We are not considering remote applicants.
The salary range for this position is $175,000 - $250,000 USD annually. This salary range is an estimate; the actual salary may vary based on the Company's compensation practices.