Regulatory CMC Lead, Gene Therapy — Global Submissions
$170k - $220kSolid Biosciences
A genetic medicine company in Boston is seeking an Associate Director of Regulatory CMC to lead regulatory strategy and bridge development with regulatory roles. This hybrid position requires strong regulatory affairs experience in biotechnology, excellent communication skills, and the ability to work collaboratively across teams. The ideal candidate will handle CMC content for clinical trials and engage with agency interactions. The role offers competitive compensation between $170,000 and $220,000 along with extensive benefits. #J-18808-Ljbffr Solid Biosciences
- ...Inc. is seeking an Associate Director, Regulatory Affairs CMC to lead regulatory CMC efforts for a portfolio of gene-based medicines. You will collaborate with... ...CMC topics, prepare high-quality submissions, and guide global teams through INDs, CTAs, #J-18808-Ljbffr...RegulatoryContract workWorldwide
- Lilly is seeking an experienced Regulatory CMC leader to develop and implement global CMC strategies for gene therapy programs. You will lead the preparation of CMC sections for IND/CTA, BLA/MAA submissions and serve as the primary liaison with major health authorities...Regulatory
- ...Boston, is seeking an Associate Director for Regulatory Affairs CMC to oversee regulatory strategies for innovative gene therapies. This leadership role requires extensive... ...guidelines, with a proven record of successful submissions. This position promotes a collaborative...RegulatoryRemote workFlexible hours
$177k - $278.08k
...delivers transformative therapies to patients. By... ...This role is within the Global Regulatory Affairs (GRA) Chemistry... ...Manufacturing & Controls (CMC) and Devices... ...the GRA CMC Franchise Lead for TAK-079 Independently... ...global registrational submissions of a complex drug product...RegulatoryMinimum wageFull timeTemporary workLocal areaRemote workWorldwide- ...seeking an Associate Director, Global Submission Management in Boston to lead a portfolio of global regulatory submissions across... ...including Pulmonary or Cell & Gene Therapy areas. You will partner with... ...Global Regulatory Strategy, CMC, Labeling, Publishing, and Advertising...Regulatory
- A public Biotech company in Boston is seeking a Regulatory Affairs CMC Manager/Senior Manager to support biologic products' global development and registration. The ideal candidate will lead the submission of regulatory documentation, ensuring compliance with FDA and EMA...Regulatory
- Takeda is seeking a senior Regulatory CMC lead in Boston, hybrid: you will own global CMC strategy and drive major submissions across development and lifecycle. You will collaborate with Regulatory, Development, and Commercial teams, negotiate with Health Authorities, and...Regulatory
- Moderna is seeking an Associate Director, Global Regulatory, CMC to coordinate regulatory CMC activities across product lifecycles and develop... ...guide product teams and prepare CMC/Quality regulatory submissions with stakeholders to drive timely approvals. The role requires...Regulatory
- Genetix Biotherapeutics is looking for a Director, Regulatory CMC to lead global regulatory strategies for gene therapy products. This full-time hybrid position based in Somerville, Massachusetts involves managing post-approval regulatory strategies and ensuring compliance...RegulatoryFull time
$212k - $333.19k
...delivers transformative therapies to patients. By focusing... ...As Senior Director and Regulatory Platform Lead GRA CMC, Device and Drug‑Device Combinations... ...implementation. Globally influence and serve as a... ...aspects of global regulatory submissions (e.g., Core Dossiers,...RegulatoryMinimum wageFull timeTemporary workLocal areaWorldwideNight shift$238k - $374k
...and delivers transformative therapies to patients. By focusing R... ....As Executive Director, Global Regulatory Affairs CMC Devices and Drug-Device Combination... ...).How you will contribute:Leads and develops a team of... ...strategy and major submissions for an assigned portfolio...RegulatoryMinimum wageTemporary workWork at officeLocal areaRemote workWorldwide$211.5k - $258.5k
...and delivering category‑leading precision therapies to transform the lives of... ...Summary The Director, Regulatory Strategy - Global Regulatory Lead is responsible... ...-IND planning, IND/CTA submission strategy, Phase I/II/III... ...with clinical, CMC, and non‑clinical development...RegulatoryLocal areaFlexible hours2 days per week$177k - $278.08k
...innovation and delivers transformative therapies to patients. By focusing R&D efforts... ...worldwide.Join Takeda as a Director, Global Regulatory Lead Oncology where you will be part of... ...global regulatory strategy and lead major submissions for high-impact oncology programs.How...RegulatoryMinimum wageTemporary workLocal areaRemote workWorldwide- ...biopharmaceutical company in Boston is seeking a Regulatory Affairs Specialist to coordinate the preparation of regulatory submission packages. The ideal candidate will have at... ...drugs, and a strong understanding of CMC requirements. Key responsibilities include managing...Regulatory
- Katalyst CRO in Boston is seeking a Regulatory Affairs professional to lead CMC strategies for investigational products. The candidate will interact with Health Authorities and manage regulatory submissions to ensure compliance and success. With a foundation in regulatory...Regulatory
- Beeline Medicines in Boston is seeking an Executive Director, Regulatory Affairs to lead global regulatory strategy for assigned programs. This role... ...Affairs & Quality and will manage global regulatory submissions (IND/CTA/NDA/MAA) and interactions with health authorities...RegulatoryWorldwide
$212k - $333.19k
...a Senior Director, Global Program Lead- Neuroscience in our... ...simultaneously driving regulatory approval as well as... ...such as Cell Therapy or Gene Therapy, large scale... ...large-scale Phase III/submission projects and global... ...Pharmaceutical Sciences (CMC) Subteam, etc. to the...RegulatoryMinimum wageTemporary workWork at officeLocal areaRemote work- Moderna is seeking an Associate Director, Global Regulatory, CMC to coordinate CMC regulatory activities across product lifecycles and to develop... .... You will guide product teams, prepare CMC and Quality submissions, and manage multiple projects in a fast-paced environment...Regulatory
- Merida Biosciences in Cambridge, MA is seeking an Associate Director of Regulatory Operations to lead global submission planning and lifecycle management across development programs. This hands-on role drives document readiness, eCTD publishing, cross-functional coordination...Regulatory
$154.4k - $242.55k
...Job DescriptionThe Plasma-Derived Therapies (PDT) R&D Organization is dedicated... ...and Precision MedicineThe Global Regulatory Labeling Strategy Lead (Associate Director), Plasma-Derived... ...regulatory team members in evolving submission and negotiation plans. Formulating...RegulatoryMinimum wageTemporary workLocal area- Develop and implement comprehensive global regulatory CMC strategies for assigned gene therapy programs, including IND/CTA, BLA/MAA, and post-approval submissions Lead and manage the preparation, authoring, and review of high-quality CMC sections for all regulatory submissions...RegulatoryFor contractorsWork at office
- ...Anagram Therapeutics, Inc. is seeking an Associate Director of Regulatory Affairs CMC to lead regulatory CMC activities across our portfolio through... ...INDs/BLAs, prepare compilations, review dossiers for submission readiness, and guide cross-functional teams to ensure compliance...Regulatory
- ...Merida Biosciences is seeking an Associate Director of Regulatory Affairs Operations. This hands-on leader will drive regulatory submission planning, execution, and lifecycle management across development programs, partnering with Regulatory Affairs leadership and cross...Regulatory
$100k - $143k
Relaytherapeutics in Cambridge, Massachusetts is looking for a motivated regulatory professional to join their regulatory team. In this role, you... ...pipeline, contributing to IND, CTA, NDA, and MAA submissions. Ideal candidates will have a B.S. or M.S., 2+ years of relevant...Regulatory$204k - $245k
...company that’s pursuing curative gene therapies to give patients and their... ...radical care. The Director, Regulatory CMC is responsible for leading execution of global CMC regulatory strategies for... ...role in supporting post‑approval submissions, inspection readiness, and ongoing...RegulatoryFull timeWork at officeFlexible hours3 days per week- ...Associate Director, Regulatory Affairs... ...Therapeutics is a leading biopharmaceutical... ...transformative gene-based medicines... ...CRISPR-based therapy, approved for eligible... ...the Regulatory CMC lead for these... ...with CMC and global development... ...requirements for submission to US and ex-US...RegulatoryContract workRemote work
$122.25k - $176.58k
...Job Title: CMC Demand & Supply Leader... ...function, in the Global CMC Project Management... ...in respect to Regulatory and Quality requirements... ...Lead collaborative work... ...PCS) and Regulator submission/approval plans.... ...Immuno-inflammation, Gene Therapy, Rare Diseases, Pharmaceutical...RegulatoryFull time- Noema Pharma in Watertown, MA is seeking a Director of Regulatory Affairs to lead regulatory strategy and oversight for multiple development programs, from IND through potential NDA/MAA submissions, and to guide cross-functional teams toward compliant execution. The ideal...Regulatory
$232.5k - $335.83k
Job Title: Global Brand Lead, Transplant (Solid Organ Transplant)Location: Morristown, NJ, Cambridge... ...-established anti-thymocyte globulin therapy, alongside a promising pipeline in... ...Access, Corporate Affairs, Digital, Regulatory, and regional commercial teams.Main ResponsibilitiesA...RegulatoryFull timeLocal area$177k - $266k
...to serve as an Early Stage CMC Program Lead. This role is responsible for... ...program objectives and regulatory expectations. The Program Lead... ...CMC content for regulatory submissions (e.g. authoring and... ...documentation and strategy comply with global regulatory guidelines....RegulatoryFull timeContract workTemporary workShift work
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