Associate Director/Director, Regulatory Affairs CMC

Candel Therapeutics•Needham, MA

9d•$160,000 - $200,000•Remote

About The Position

The Associate Director/Director, Regulatory Affairs CMC will serve as the CMC regulatory lead for one or more viral vector-based gene therapy programs across the product lifecycle, from preclinical development through clinical trials, marketing application (BLA/MAA), and post-approval lifecycle management. This individual, in collaboration with cross-functional stakeholders, will develop and execute global CMC regulatory strategies, author and review CMC sections of regulatory submissions, and serve as a key liaison with health authorities on manufacturing, analytical, and quality matters. The successful candidate will bring deep expertise in the CMC regulatory landscape for biological products, ideally with hands-on experience in viral vector-based gene therapies (adenovirus, AAV, or other modalities). This role requires the ability to navigate evolving regulatory expectations and to translate complex manufacturing and analytical challenges into sound regulatory strategy.

Requirements

Bachelor's degree in a scientific discipline (e.g., Biochemistry, Molecular Biology, Chemistry, Pharmacy, Chemical Engineering) is required.
8+ years of progressive experience in regulatory affairs within the biopharmaceutical industry, with a minimum of 5 years focused on CMC regulatory.
At least 3 years of direct experience with biologics (cell and/or gene therapy products and viral vector-based preferred).
Demonstrated track record of authoring and submitting CMC sections of INDs, CTAs, BLAs/MAAs, or equivalent regulatory filings.
Experience interacting with FDA (CBER/OTP preferred), EMA, or other major health authorities on CMC matters.
Working knowledge of cGMP manufacturing for viral vectors, including upstream/downstream processing, analytical characterization, and release testing.
Excellent written and verbal communication skills, with the ability to articulate complex scientific and regulatory concepts clearly and concisely.
Proven leadership and interpersonal skills, with the ability to influence and collaborate effectively with diverse cross-functional teams and external stakeholders.
Strategic thinker with strong problem-solving and decision-making abilities.
Ability to manage multiple projects simultaneously in a fast-paced and dynamic environment.
Proven collaboration with manufacturing, analytical development, quality, research, biostatistics and clinical teams; consistent milestone and risk tracking with timely issue resolution
Ability to work core Eastern or Central U.S. hours (remote, U.S.-based)
Applicants must be legally authorized to work in the United States at the time of hire and throughout employment. We are unable to provide, assume, or sponsor work visas or employment authorization for this role now or in the future.

Responsibilities

Develop and execute phase-appropriate global CMC regulatory strategies for assigned viral vector-based gene therapy programs, ensuring alignment with FDA, EMA, and ICH expectations.
Lead preparation, review, and submission of CMC sections for INDs/IMPDs, CTAs, BLAs/MAAs, annual reports, supplements, variations, and health authority responses.
Provide strategic CMC regulatory input to product development plans, including manufacturing process changes, analytical method development, and comparability assessments.
Serve as CMC regulatory representative in health authority meetings (Pre-IND, Type A/B/C, Scientific Advice, PLI readiness).
Prepare CMC module sections, briefing documents, meeting requests, and responses to information requests or clinical holds related to CMC issues.
Monitor and interpret evolving regulatory guidance relevant to viral vector-based gene therapies, including empty/full capsid characterization, potency assay strategies, and process validation expectations.
Partner with manufacturing, analytical development, quality, research, biostatistics and clinical teams to ensure regulatory alignment across CMC activities.
Collaborate with CDMO partners and external regulatory consultants on CMC regulatory deliverables and strategy.
Support due diligence activities for business development and in-licensing opportunities, assessing CMC regulatory risk and readiness.
Maintain current knowledge of global CMC regulatory requirements for gene therapy products, including ICH guidelines (Q5A–Q14), FDA CBER guidance, EMA ATMPs framework, and Ph. Eur. chapters.
Proactively identify regulatory risks and develop mitigation strategies for CMC-related issues such as comparability, low endotoxin recovery (LER), release testing strategy, and supply chain compliance.
Contribute to internal SOPs, regulatory process improvements, and best practices for CMC regulatory operations.