Director, Regulatory CMC
About The Position
The Director of Regulatory CMC will lead the development and execution of global CMC regulatory strategies for our pipeline of small molecules and monoclonal antibodies to accelerate clinical development and ensure seamless commercialization. Acting as a key partner to CMC and Quality, this role is responsible for the CMC content of all investigational and marketing applications, ensuring technical consistency and compliance across all stages of the product lifecycle, from early-stage development through commercialization. This role requires a blend of deep scientific fluency, meticulous attention to detail, and the ability to negotiate effectively with global health authorities. The ideal candidate has a deep understanding of the nuanced differences in regulatory pathways for both small molecules and monoclonal antibodies.
Requirements
- B.S./M.S. in a scientific discipline (Chemistry, Biology, or Pharmacy); A Ph.D. or PharmD is highly preferred
- 10+ years of experience in the biopharmaceutical industry, with at least 7 years focused specifically on CMC Regulatory Affairs
- Successful track record of contributing to least one major marketing application (NDA or BLA) from initial drafting through approval
- Strong understanding of GMP (Good Manufacturing Practices) and ICH guidelines and deep knowledge of small molecule and mAbs modalities
- Ability to interpret complex technical data (e.g., mass spectrometry, impurity profiles, dissolution data) and effectively present it in a clear, regulatory-compliant narrative
- Deep knowledge of FDA, EMA, ICH regulations, and global regulatory requirements
- Exceptional communication and interpersonal skills, with the ability to effectively interact and influence internally with cross-functional stakeholders and senior leadership and externally with CMOs and regulatory authorities
- Must be willing to work onsite at least four days per week
Responsibilities
- Design and implement innovative global CMC regulatory strategies to secure approvals and maintain compliance for clinical and commercial products, identifying potential risks and creating robust mitigation plans
- Provide expert guidance on CMC requirements for both Small Molecules (NCEs) and Biologics (mAbs), including comparability protocols and stability requirements
- Act as the primary CMC point of contact for the FDA, EMA, and other global health authorities
- Lead preparations for and represent the company in formal regulatory meetings and in generating responses to Health Authority queries
- Assess the impact of manufacturing changes on global registrations and determine the necessary reporting categories globally
- Define the necessary data packages to support post-approval supplements
- Author or direct the preparation, authoring, and technical review of CMC sections for global filings: -ND/IMPD: Investigational applications for early-phase trials -NDA/BLA/MAA: Marketing applications for US, EU, and other major markets
- Manage the lifecycle of the Common Technical Document (CTD) specifically focusing on Module 3 (Quality) and Module 2.3 (Quality Overall Summary)
- Collaborate closely with Process Development, Analytical Development, and Quality Assurance to ensure data integrity and filing readiness
- Provide regulatory risk assessments for various manufacturing scenarios (e.g., changing CDMO sites or scaling up bioreactors)
- Monitor and stay current on the evolving CMC regulations (ICH guidelines, FDA/EMA guidance) and translate complex requirements into actionable internal plans
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What This Job Offers
Job Type
Full-time
Career Level
Director
