Manager, Regulatory Affairs CMC

Job Title: Manager, Regulatory Affairs CMC

Job Number: 37271

Location: San Diego,CA

Job Description

The Manager, CMC Regulatory Affairs is responsible for executing Chemistry, Manufacturing, and Controls (CMC) regulatory activities across the product lifecycle, with a primary focus on supporting the BLA pathway and advancing other pipeline candidates from development through potential commercial approval and post-approval maintenance. This role supports the development and implementation of CMC regulatory strategy, ensures compliance with global regulatory requirements (including FDA, ICH, and EMA guidelines), and partners closely with cross-functional teams (e.g., CMC Development, Manufacturing, Quality Assurance, Clinical, and Regulatory) to enable timely submissions, successful interactions with health authorities, and achievement of company objectives in a dynamic biotech environment.

Responsibilities

• Contribute to the development and implementation of CMC regulatory strategy throughout the product lifecycle—from early development through commercialization and post-approval—to ensure compliance with global regulatory standards.

• Take the lead in preparing, writing, reviewing, compiling, and submitting CMC components of regulatory filings, including IND amendments, BLA modules, supplements, annual reports, responses to agency inquiries, and post-approval changes.

• Partner with CMC, Manufacturing, Quality Assurance, Process Development, and other cross-functional teams to ensure required source documentation (such as stability data, comparability protocols, and process validation reports) is generated, reviewed, and approved in a timely manner to support submissions.

• Review and sign off on CMC-related documents requiring Regulatory Affairs input, including change controls, regulatory impact evaluations, technical documentation, stability protocols, validation plans, and deviation investigations.

• Serve as a primary point of contact with health authorities—primarily the FDA and potentially the EMA—for CMC-related submissions, meetings (e.g., Type meetings, pre-submission discussions), negotiations, and responses to agency questions or deficiencies, including resolution of prior BLA feedback.

• Track and evaluate updates to global regulatory requirements and guidance (such as ICH revisions and FDA biologics guidance for cell therapies), assess their impact on company programs, and provide proactive recommendations to leadership.

• Participate in regulatory risk assessments, gap analyses, and contingency planning related to CMC submissions and lifecycle management.

• Assist with CMC-related inspection readiness efforts for manufacturing sites and supporting documentation.

• Carry out additional responsibilities as assigned.

Required Skills

• A bachelor’s degree in Pharmacy, Chemistry, Chemical Engineering, Life Sciences, or a related discipline is required; an advanced degree (MS, PhD, Pharm
  
  D, etc.) is strongly preferred.

• At least five years of regulatory affairs experience with significant CMC responsibility in the pharmaceutical or biotechnology sector, ideally supporting biologics, cell or gene therapies, or other advanced therapy medicinal products (ATMPs).

• Proven track record of drafting, compiling, and submitting CMC components of major regulatory applications—such as INDs, BLAs, NDAs, MAAs, and supplements—to the FDA and/or EMA, including preparation of responses to agency questions.

• In-depth understanding of global CMC regulatory frameworks for biologics and cell therapies, including ICH guidelines (Q8–Q12), FDA guidance on CMC requirements for cellular therapies, and principles related to comparability, process validation, and stability.

• Experience contributing to BLA or comparable submissions for regenerative medicine products; familiarity with resolving CMC deficiencies or responding to Complete Response Letters is a plus.

• Strong organizational and project management capabilities, with the ability to juggle multiple priorities and deadlines in a dynamic environment.

• Excellent written and verbal communication skills to effectively engage internal teams, external collaborators, and regulatory authorities.

• Experience using regulatory information management systems (e.g., Veeva RIM) and document authoring tools.

• Demonstrated ability to work autonomously while maintaining strong collaboration with cross-functional teams across scientific, manufacturing, and quality functions.

Work Environment / Physical Requirements

• Primarily office-based, with responsibilities centered on regulatory documentation, strategic planning, and coordination across departments.

• Requires extended periods of computer use for drafting, reviewing, compiling, and tracking CMC-related submissions.

• May occasionally need to lift office materials weighing up to 15 pounds.

• Ability to work in a standard office setting and travel periodically for regulatory meetings, agency interactions, or site visits, as required.

Salary: 120-140K plus benefits