Director Regulatory Site CMC (Hybrid) - Post-Approval
$174.5k - $274.23kBioSpace
A leading biopharmaceutical company is seeking a Director Regulatory Site CMC in Boston, MA. The role focuses on regulatory change control and post-approval activities, ensuring compliance across diverse modalities. Candidates should have over 10 years of experience in the biopharmaceutical industry, with a strong background in global HA requirements and regulatory strategy. This hybrid position offers a competitive salary range between $174,500 and $274,230 alongside comprehensive benefits. #J-18808-Ljbffr BioSpace
$184.6k - $277k
...General Summary The CMC Quality Compliance Director is responsible... ...and external sites including evaluating... ...interpret cGMP regulatory guidelines and... ...at the time of posting. This role is eligible... ...Designation Hybrid-Eligible Or On-... ...The company has approved medicines that treat...WebsiteWork experience placementSummer workRemote workFlexible hours2 days per week$190.4k - $285.6k
...DescriptionGeneral Summary:The Director, Chemistry Manufacturing Controls (CMC) leads a Regulatory CMC team... ..., review, and approval of CMC content for... ...job at the time of posting. This role is eligible... ...more.Flex Designation:Hybrid-Eligible Or On-Site EligibleFlex...WebsiteFull timeSummer workRemote workFlexible hours2 days per week$174.5k - $274.23k
...therapies to patients worldwide. The Director Regulatory Site CMC ensures efficient and compliant... ...management of regulatory change control and post‑approval activities at the site level.... ...position is currently classified as “hybrid” following Takeda’s Hybrid and Remote...WebsiteMinimum wageTemporary workLocal areaRemote workWorldwide$242k - $313.5k
.... Job Summary The Senior Director, Regulatory Affairs CMC - Biologics provides senior... ...through BLA filing and post‑approval lifecycle management, serving... ...Arrangement & Location Hybrid - This position follows a... ...minimum of two (2) days on‑site per week — currently designated...WebsiteLocal areaFlexible hours2 days per week- 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...SuggestedFull time
- ...Summary:The Associate Director, CMC Quality Compliance and... ...compliance of external sites including evaluating,... ...and Skills:Knowledge of regulatory requirements and... ...international travel possible Hybrid-Eligible RolesIn this... ...job at the time of posting. This role is eligible...WebsiteFull timeSummer workRemote workFlexible hours2 days per week
$166.4k - $249.6k
...Manufacturing Controls (CMC) Associate Director leads and executes global regulatory CMC strategies... ...job at the time of posting. This role is eligible... ...more. Flex Designation Hybrid-Eligible Or On-Site Eligible Flex... ...diseases. The company has approved medicines that treat...WebsiteSummer workRemote workFlexible hours2 days per week- ...Associate Director, Regulatory Affairs CMC Founded over a decade ago, CRISPR Therapeutics is a leading... ...marking a historic milestone with the approval of CASGEVY® (exagamglogene autotemcel... ...employees work at least three days on-site, creating a collaborative work environment...WebsiteContract workRemote work
$275k - $315k
...and experienced Senior Director of Regulatory Affairs to lead and... ...through BLA submission and approval. You will manage a... ...office and follows a hybrid schedule, with three in... ...Clinical, Nonclinical, CMC, Biostatistics, Clinical... ...directly at the tumor site. FICERA specifically...WebsiteFull timeTemporary workWork at officeLocal area3 days per week$182k - $275k
...-quality, science-based, and compliant regulatory CMC deliverables for assigned program(s), in... ...applications, marketing applications, post-approval submissions, and health authority responses... ..., Massachusetts. Rhythm operates in a hybrid-work model. Candidates applying must be...Work at office$177k - $278.08k
...This role is within the Global Regulatory Affairs (GRA) Chemistry Manufacturing & Controls (CMC) and Devices organization, and... ..., registration and post-approval strategies for their assigned... ...position is currently classified as "hybrid" following Takeda's Hybrid and...Minimum wageTemporary workLocal areaRemote workWorldwide$224.9k - $404.6k
...be based at Norwood MA site and will be responsible... ...for managing a team of CMC experts that prepare and... ...correspondence and regulatory applications. This position... ...facilitate review and approval of submissions at the expert... ...at the time of this posting. An individual’s...WebsitePermanent employmentFull timeWork at officeWork from home$207k - $253k
...the first and only medication approved by both the FDA and European... ...strategic, tactical and operational regulatory CMC leadership to support... ...applications, market registrations and post-approval submissions, along... ...through our Madrigal Careers site. Please be aware...WebsiteMinimum wageFull timeLocal areaFlexible hours- ...Switzerland GmbH in Cambridge, MA is seeking an Associate Director, Regulatory Affairs CMC to lead the development and execution of global... ...and proven regulatory leadership. The position allows for hybrid work arrangements, reflective of Alnylam's commitment to...
$204k - $245k
...Director, Regulatory CMC Somerville, MA At Genetix Biotherapeutics every role... ...regulatory strategies for approved and late-stage gene therapy... ...development and delivery of post-approval regulatory strategies... .... This is a full-time hybrid position (3 days a week) in...Full timeWork at officeFlexible hours3 days per week$238k - $374k
...patients worldwide.As Executive Director, Global Regulatory Affairs CMC Devices and Drug-Device... ...and minimizing time to approval/clearance.Establish best practices... ...evidence, labeling/UDI, post-market signals).... ...currently classified as "hybrid" following Takeda's Hybrid...Minimum wageTemporary workWork at officeLocal areaRemote workWorldwide$200k - $220k
Director/ Senior Director, Regulatory CMC Join Us in Tackling Autoimmune Disease at Its Root At Vor, we believe science can do more than manage symptoms... ...submissions from early development to pre‑ and post‑approval submissions and product lifecycle management in the area...WebsiteContract workWorldwideFlexible hours$211.5k - $258.5k
Job Summary The Director, Regulatory Strategy - Global Regulatory... ...& Location Hybrid - This position follows... ...minimum of two (2) days on-site per week — currently... ...alignment with clinical, CMC, and non-clinical... ...from pre‑IND through post‑approval. Extensive experience...WebsiteLocal areaFlexible hours2 days per week$170.9k - $231.3k
Overview The Associate Director, Regulatory Affairs CMC Development is responsible for developing and implementating... ...landscape.This position is hybrid and primarily located in our Cambridge... ...to pay for this role at the time of posting. Base pay will be determined based on...WebsiteFull timeTemporary workWork at officeLocal areaFlexible hours- Alkermes in Boston is seeking an Associate Director of Regulatory Affairs, Advertising and Promotion who... ...and review promotional materials. Hybrid work arrangement requires 60% office presence with at least 3 days/week on site at MA office. #J-18808-Ljbffr AlkermesWebsiteWork at office3 days per week
- Beeline Medicines seeks a Senior Director, Regulatory Affairs CMC - Biologics to lead regulatory science for biologics assets, including monoclonal antibodies, from IND/CTA through BLA and post‑approval lifecycle. You will collaborate with Process Development, Analytical...
$241k - $332k
About This Role:As the Head of Regulatory CMC - Biologics & Advanced... ...strategic oversight to ensure timely approvals and lifecycle progression.... ...supply continuity.This is a hybrid role to be based at our Headquarters... ....Provide oversight for post-approval lifecycle activities...Full timeTemporary workLocal area$163.5k - $281.6k
...Company is seeking a highly experienced and strategic Director/Senior Director, Regulatory CMC to lead and execute regulatory CMC strategies for our... ...therapy programs, including IND/CTA, BLA/MAA, and post-approval submissions.Lead and manage the preparation, authoring...For contractorsWork at officeFlexible hours- Lindt is seeking a Compliance and Internal Controls leader in the United States for a hybrid role with three days on site in the Stratham, NH corporate office or our Boston office. You will oversee the company’s compliance framework, risk assessments, control testing and...WebsiteWork at office
$238k - $374k
...true to the best of my knowledge.Job DescriptionExecutive Director, Global Regulatory Affairs CMC Early DevelopmentAre you looking for a patient-focused... ...strategies.This position is currently classified as “hybrid” in accordance with Takeda’s Hybrid and Remote Work policyTakeda...Minimum wageTemporary workLocal areaRemote work- Vertex Pharmaceuticals Incorporated seeks a Chemistry Manufacturing Controls Manager to oversee regulatory CMC submissions and strategic interactions with agencies. You will partner with development and manufacturing teams to shape global CMC strategies for investigational...Remote work
$224.9k - $404.6k
Moderna is seeking a regulatory CMC expert to manage a team at their Norwood, MA site. This key leadership role involves overseeing the product strategy for all portfolio products, managing regulatory submissions, and ensuring adherence to quality standards. Ideal candidates...Website- Position Summary The Director of Regulatory Affairs at MBX Biosciences will lead... ...support the development and approval of MBX’s clinical stage and... ...Schedule This role operates in a hybrid work model, with an... ...expectation of an average of three on‑site days per week at the...Website3 days per week
$281k - $344k
...Summary: The Executive Director, Regulatory Affairs will report to the Senior... ...any future marketing approvals globally and developing and... ...Arrangement & Location: Hybrid - This position follows a hybrid... ...minimum of two (2) days on-site per week - currently designated...WebsiteFor contractorsLocal areaFlexible hours2 days per week- 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...For contractorsWork at office
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