{"schemaVersion":"jobsearcher.job.v1","id":"768ea8192cb7b22d1f5563be","url":"https://jobsearcher.com/jobs/768ea8192cb7b22d1f5563be","canonicalUrl":"https://jobsearcher.com/jobs/768ea8192cb7b22d1f5563be","title":"Associate Director, Regulatory Affairs, CMC","description":"If you are unable to complete this application due to a disability, contact this employer to ask for an accommodation or an alternative application process.Associate Director, Regulatory Affairs, CMCFull Time Professional Berkeley, CA, US4 days ago Requisition ID: 1002Salary Range: $175,000.00 To $195,000.00 AnnuallyReporting to the Chief Regulatory Officer, the Associate Director, Regulatory Affairs will serve as a key member of the Regulatory organization, responsible for developing and executing global Chemistry, Manufacturing, and Controls (CMC) regulatory strategies for clinical-stage gene therapy programs. This individual will partner cross-functionally with CMC, Technical Operations, Quality, and Clinical teams to ensure timely, compliant, and high-quality regulatory submissions and lifecycle management activities.Key Responsibilities include but are not limited to:Develop and execute global CMC regulatory strategies across all phases of development (IND/CTA through BLA/MAA and lifecycle management)Provide strategic input on manufacturing changes, comparability approaches, and control strategiesAnticipate regulatory risks and propose mitigation strategies aligned with agency expectations (FDA, EMA, PMDA, MHRA)Lead preparation and authorship of CMC sections (Module 2.3, 3) for:INDs / CTAs / AmendmentsBriefing documents and health authority interactionsBLA/MAA submissions and supplements/variationsEnsure alignment of CMC documentation with overall regulatory strategy and program timelinesOversee document quality, consistency, and compliance with global regulatory requirementsServe as CMC regulatory lead for agency interactions (e.g., Type B/C meetings, Scientific Advice)Prepare and review CMC briefing materials and response documentsSupport inspection readiness activities, including coordination with Quality and Manufacturing teamsProvide regulatory guidance on manufacturing process development, analytical methods, specifications, and stability strategiesEnsure alignment across regions and maintain awareness of evolving regulatory expectations for advanced therapiesQualifications:Bachelor's degree in life sciences or related field required; advanced degree (MS, PhD, PharmD) preferred.~8–12+ years of regulatory affairs experience in biotech/pharma.Experience supporting biologics and/or gene/cell therapy products strongly preferred.Direct experience with IND/CTA submissions and global regulatory interactions required.Deep knowledge of CMC development for biologics/ATMPs, Module 3 structure and expectations, and comparability and change management strategies.Familiarity with global regulatory frameworks (FDA, EMA, ICH guidelines)Proven ability to operate effectively in a small, fast-paced biotech environmentStrong cross-functional leadership and influencing skills without direct authorityExcellent written and verbal communication skills, with the ability to translate complex CMC topics into clear regulatory strategiesCompensation Range and Benefits:For this role, the anticipated base salary range: $175,000 to $195,000, based on the candidate's professional experience level. The final salary offered for this position may take into account a number of factors including, but not limited to skills, education, and experience.Ray Therapeutics also offers annual performance-based bonus, annual equity awards and a comprehensive benefits package.J-18808-Ljbffr","company":"Evolving Solution Services","rawCompany":"evolving solution services","city":"Berkeley","state":"CA","isRemote":false,"isActive":false,"createdAt":"2026-05-27T00:33:26.901Z","occupations":[{"code":"11-9199.01","title":"Regulatory Affairs Managers","slug":"regulatory-affairs-managers"},{"code":"13-1041.07","title":"Regulatory Affairs Specialists","slug":"regulatory-affairs-specialists"},{"code":"11-9199.02","title":"Compliance Managers","slug":"compliance-managers"}],"industries":[{"code":"541714","title":"Research and Development in Biotechnology (except Nanobiotechnology)","slug":"research-and-development-in-biotechnology-except-nanobiotechnology"},{"code":"541715","title":"Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology)","slug":"research-and-development-in-the-physical-engineering-and-life-sciences-except-nanotechnology-and-biotechnology"},{"code":"325414","title":"Biological Product (except Diagnostic) Manufacturing","slug":"biological-product-except-diagnostic-manufacturing"}],"jobPosting":{"@context":"https://schema.org","@type":"JobPosting","title":"Associate Director, Regulatory Affairs, CMC","description":"If you are unable to complete this application due to a disability, contact this employer to ask for an accommodation or an alternative application process.Associate Director, Regulatory Affairs, CMCFull Time Professional Berkeley, CA, US4 days ago Requisition ID: 1002Salary Range: $175,000.00 To $195,000.00 AnnuallyReporting to the Chief Regulatory Officer, the Associate Director, Regulatory Affairs will serve as a key member of the Regulatory organization, responsible for developing and executing global Chemistry, Manufacturing, and Controls (CMC) regulatory strategies for clinical-stage gene therapy programs. This individual will partner cross-functionally with CMC, Technical Operations, Quality, and Clinical teams to ensure timely, compliant, and high-quality regulatory submissions and lifecycle management activities.Key Responsibilities include but are not limited to:Develop and execute global CMC regulatory strategies across all phases of development (IND/CTA through BLA/MAA and lifecycle management)Provide strategic input on manufacturing changes, comparability approaches, and control strategiesAnticipate regulatory risks and propose mitigation strategies aligned with agency expectations (FDA, EMA, PMDA, MHRA)Lead preparation and authorship of CMC sections (Module 2.3, 3) for:INDs / CTAs / AmendmentsBriefing documents and health authority interactionsBLA/MAA submissions and supplements/variationsEnsure alignment of CMC documentation with overall regulatory strategy and program timelinesOversee document quality, consistency, and compliance with global regulatory requirementsServe as CMC regulatory lead for agency interactions (e.g., Type B/C meetings, Scientific Advice)Prepare and review CMC briefing materials and response documentsSupport inspection readiness activities, including coordination with Quality and Manufacturing teamsProvide regulatory guidance on manufacturing process development, analytical methods, specifications, and stability strategiesEnsure alignment across regions and maintain awareness of evolving regulatory expectations for advanced therapiesQualifications:Bachelor's degree in life sciences or related field required; advanced degree (MS, PhD, PharmD) preferred.~8–12+ years of regulatory affairs experience in biotech/pharma.Experience supporting biologics and/or gene/cell therapy products strongly preferred.Direct experience with IND/CTA submissions and global regulatory interactions required.Deep knowledge of CMC development for biologics/ATMPs, Module 3 structure and expectations, and comparability and change management strategies.Familiarity with global regulatory frameworks (FDA, EMA, ICH guidelines)Proven ability to operate effectively in a small, fast-paced biotech environmentStrong cross-functional leadership and influencing skills without direct authorityExcellent written and verbal communication skills, with the ability to translate complex CMC topics into clear regulatory strategiesCompensation Range and Benefits:For this role, the anticipated base salary range: $175,000 to $195,000, based on the candidate's professional experience level. The final salary offered for this position may take into account a number of factors including, but not limited to skills, education, and experience.Ray Therapeutics also offers annual performance-based bonus, annual equity awards and a comprehensive benefits package.J-18808-Ljbffr","datePosted":"2026-05-27T00:33:26.901Z","dateModified":"2026-05-27T00:33:26.901Z","hiringOrganization":{"@type":"Organization","name":"Evolving Solution Services","sameAs":"https://jobsearcher.com"},"jobLocation":{"@type":"Place","address":{"@type":"PostalAddress","addressLocality":"Berkeley","addressRegion":"CA","addressCountry":"US"}},"identifier":{"@type":"PropertyValue","name":"JobSearcher","value":"768ea8192cb7b22d1f5563be"},"url":"https://jobsearcher.com/jobs/768ea8192cb7b22d1f5563be"}}