Senior Manager/Associate Director, CMC Regulatory Affairs
About The Position
The Senior Manager, Regulatory CMC will be responsible for the planning, preparation, and execution of Chemistry, Manufacturing, and Controls (CMC) regulatory activities for investigational and commercial products, including small molecule and antisense oligonucleotide (ASO) programs. This role will work closely with cross-functional partners and external vendors to support global regulatory submissions, health authority interactions, and lifecycle management activities. The ideal candidate is a hands-on regulatory professional with strong CMC technical knowledge who thrives in a fast-paced biotech environment and is comfortable managing multiple programs across different stages of development.
Requirements
- Bachelor’s or Master’s degree in Chemistry, Pharmaceutical Sciences, Chemical Engineering, or a related scientific discipline (advanced degree preferred).
- 5+ years of Regulatory Affairs experience with a focus on CMC.
- Hands-on experience preparing and/or managing CMC sections of INDs and NDAs/BLAs.
- Familiarity with FDA and global regulatory CMC requirements across development and commercial stages.
- Experience working with external manufacturing and testing partners.
- Solid understanding of CMC regulatory requirements and expectations.
- Strong project management and organizational skills, with the ability to manage multiple priorities.
- Excellent written and verbal communication skills.
- Detail-oriented, collaborative, and proactive problem solver.
- Ability to work effectively in a cross-functional, matrixed environment
Nice To Haves
- Experience supporting small molecule drug products; experience with antisense oligonucleotides (ASOs) or other oligonucleotide-based therapies is strongly preferred.
Responsibilities
- Support development and execution of global CMC regulatory strategies for investigational and commercial small molecule and ASO programs, under the direction of the Senior Director.
- Author, compile, and review CMC sections of regulatory submissions, including INDs, IMPDs, NDAs, BLAs, amendments, and post-approval supplements.
- Coordinate CMC content development with Quality, Analytical, Development, and Commercial Manufacturing teams to ensure accuracy, alignment, and readiness for submission.
- Support and participate in health authority interactions, including preparation of briefing documents, responses to information requests, and meeting logistics.
- Maintain regulatory compliance for CMC activities supporting clinical supply, commercial manufacturing, and ongoing product supply, including stability updates and annual reports.
- Assist with post-approval change management, including comparability assessments, manufacturing changes, and technology transfers.
- Manage and coordinate external consultants, CMOs, CROs, and regulatory vendors supporting CMC regulatory activities.
Benefits
- 99% of the premium paid for medical, dental and vision plans.
- company-paid life insurance, AD&D, disability benefits, and voluntary plans to personalize your coverage
- dollar-for-dollar match up to 6% on eligible 401(k) contributions
- long-term stock incentives and ESPP
- discretionary quarterly bonus
- extremely flexible wellness benefit
- generous PTO, paid holidays and company-wide shutdowns
Stand Out From the Crowd
Upload your resume and get instant feedback on how well it matches this job.
What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Number of Employees
101-250 employees
