Hiring: Director, Regulatory CMC Company: Calico Life Sciences Location: South San Francisco, CA Job Posted Time: 2026-09-03 14:33:51 Employment Type: On-site Target Skills & Keywords : Interaction Design, Quality Assurance About the job Experience: •10+ years of experience in the biopharmaceutical industry, with at least 7 years focused specifically on CMC Regulatory Affairs •At least 7 years focused specifically on CMC Regulatory Affairs Required Skills: •Regulatory Strategy and Agency Interactions •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 •Submissions and Document Leadership Qualifications: •B.S./M.S. in a scientific discipline (Chemistry, Biology, or Pharmacy); A Ph.D. or PharmD is highly preferred •Successful track record of contributing to least one major marketing application (NDA or BLA) from initial drafting through approval •In-depth knowledge of GMP (Good Manufacturing Practices) and ICH guidelines and deep knowledge of small molecule and mAbs modalities •Demonstrated capacity 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 •The estimated base salary range for this role is $275,000 - $280,000. Actual pay will be based on a number of factors including experience and qualifications. This position is also eligible for two annual cash bonuses. Compensation: •$275,000 - $280,000 / year Interested candidates, please apply directly through the job posting on company's career page or try via AI auto apply on this platform. Don't miss this opportunity to join a forward-thinking team!