My client is a late-stage clinical biopharmaceutical company focused on addressing some of the most challenging mechanisms of cancer resistance through innovative, science-driven drug development. This opportunity offers the chance to work alongside a highly accomplished leadership team in a collaborative, mission-driven environment where individual contributions can directly advance novel therapies for patients with cancer.
Position: Reporting to the Senior Vice President, Regulatory Affairs, the Senior Director, Regulatory Affairs CMC will serve as the lead CMC regulatory expert supporting products in clinical development. This is a highly visible role that will partner closely with Regulatory Affairs, Technical Operations, Pharmaceutical Development, Manufacturing, Quality, Clinical Operations, Regulatory Operations, and Executive Leadership to drive global CMC strategy and execution.
This position is ideal for a regulatory professional who thrives in a fast-paced biotech environment and enjoys owning both the strategic and operational aspects of Regulatory CMC while advancing programs through late-stage development and registration.
Responsibilities:
- Lead the development and execution of global Regulatory CMC strategies for products throughout clinical development and commercialization.
- Serve as the primary Regulatory CMC representative on cross-functional program teams.
- Author, review, and oversee preparation of CMC regulatory documentation supporting INDs, CTAs, amendments, annual reports, marketing applications, and lifecycle management activities.
- Lead development of Module 2 and Module 3 content and ensure regulatory compliance of all CMC submission components.
- Provide strategic guidance regarding manufacturing changes, process improvements, analytical updates, and comparability assessments.
- Assess regulatory impact of CMC changes and develop global filing strategies to support implementation.
- Coordinate and support regulatory interactions with global health authorities, including preparation of briefing materials, responses, and meeting support.
- Partner closely with Technical Operations, Pharmaceutical Development, Manufacturing, Quality Assurance, Clinical Supply, and Regulatory Operations teams.
- Maintain awareness of evolving global CMC regulations, guidance documents, and industry trends.
Qualifications:
- BS, MS, or PhD in a scientific discipline.
- 10+ years of progressive Regulatory Affairs CMC experience within pharmaceutical or biotechnology organizations.
- Strong Regulatory CMC experience supporting small molecule development programs.
- Demonstrated experience supporting products through late-stage clinical development, registration, and post-approval activities.
- Significant hands-on experience authoring and reviewing CMC sections of INDs, CTAs, NDAs, and global submissions.
- Experience supporting oncology or other complex therapeutic area development programs.
- Experience advancing products from late-stage clinical development through marketing application submission.
- Background supporting solid oral dosage forms and outsourced manufacturing networks.
- Experience working within emerging or growth-stage biotechnology companies.
- Deep knowledge of Module 2 and Module 3 requirements and eCTD submission structure.
- Strong understanding of FDA, EMA, ICH, and global CMC regulatory requirements.
- Experience supporting health authority interactions and CMC-related regulatory responses.
- Exceptional technical writing, communication, organizational, and project management skills.
- Oncology experience preferred.