Associate Director, CMC Regulatory Affairs — Hybrid
Jobleads-US
Alnylam Switzerland GmbH in Cambridge, MA is seeking an Associate Director, Regulatory Affairs CMC to lead the development and execution of global regulatory strategies for innovative therapeutics, particularly in CMC Development.
This role combines scientific expertise with strong leadership and project management skills, requiring 8-10 years of industry experience and proven regulatory leadership. The position allows for hybrid work arrangements, reflective of Alnylam's commitment to flexibility.
#J-18808-Ljbffr Jobleads-US- Job DescriptionGeneral Summary:The Associate Director, CMC Quality Compliance and Inspection Readiness... ...and Skills:Knowledge of regulatory requirements and inspection expectations... ...including international travel possible Hybrid-Eligible RolesIn this Hybrid-Eligible...SuggestedFull timeSummer workRemote workFlexible hours2 days per week
$154.4k - $242.55k
...patients worldwide.This role is within the Global Regulatory Affairs (GRA) Chemistry Manufacturing & Controls (CMC) and Devices organization, and will contribute to... ...world.This position is currently classified as "hybrid" following Takeda's Hybrid and Remote Work policy...SuggestedMinimum wageTemporary workLocal areaRemote workWorldwide$170.9k - $231.3k
Overview The Associate Director, Regulatory Affairs CMC Development is responsible for developing and implementating global CMC regulatory strategies for... ...evolving global regulatory landscape.This position is hybrid and primarily located in our Cambridge, MA or Philadephia...SuggestedFull timeTemporary workWork at officeLocal areaFlexible hours$166.4k - $249.6k
...Chemistry Manufacturing Controls (CMC) Associate Director leads and executes global regulatory CMC strategies across... ...Chemistry, Pharmacy, Regulatory Affairs, or related life science field (... ...and so much more.Flex Designation:Hybrid-Eligible Or On-Site EligibleFlex...SuggestedFull timeSummer workRemote workFlexible hours2 days per week- ...DescriptionGeneral Summary:The CMC Quality Compliance Director is responsible for... ...compliance including processes and associated governance across all GMP... ...and interpret cGMP regulatory guidelines and trends in the... ...Travel may be required#LI-hybrid #LI-JS1Pay Range:$184,600...SuggestedFull timeWork 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 responsible for developing... ...Biology, Pharmacy, Regulatory Affairs, Pharmaceutical Sciences,... ...so much more.Flex Designation:Hybrid-Eligible Or On-Site EligibleFlex...Full timeSummer workRemote workFlexible hours2 days per week- ...Associate Director Of Regulatory Affairs Cmc Hybrid Role The Associate Director of Regulatory Affairs CMC will support development CMC team activities for an emerging portfolio of biologics products. This position will oversee CMC Health Authority submissions, collaborating...
- ...Associate Director, Regulatory Affairs CMC Founded over a decade ago, CRISPR Therapeutics is a leading biopharmaceutical company focused on developing transformative gene-based medicines for serious human diseases. The Company has evolved from a pioneering research...Contract workRemote work
$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$238k - $374k
...-changing therapies to patients worldwide.As Executive Director, Global Regulatory Affairs CMC Devices and Drug-Device Combination Product, you will provide... ...the world.This position is currently classified as "hybrid" following Takeda's Hybrid and Remote Work policy.#LI-...Minimum wageTemporary workWork at officeLocal areaRemote workWorldwide- Vertex Pharmaceuticals Incorporated is seeking a Chemistry Manufacturing Controls Manager to lead regulatory CMC activities for both investigational and commercial products. The role involves reviewing CMC sections, developing global strategies, and coordinating with cross...
$242k - $313.5k
Senior Director, Regulatory Affairs CMC - Biologics About Beeline Medicines: Beeline Medicines is a clinical‑stage biotechnology company focused on... ...infrastructure. Work Arrangement & Location: Hybrid - This position follows a hybrid work schedule, requiring...Local area2 days per week$182k - $208k
...eager to contribute to establishing an engaged, inclusive, and positive company culture. Job Title: Associate Director, Regulatory CMC (Biologics) Location: Hybrid – Waltham, MA . Candidates will be required to be in-office3 days/week. We are seeking an...Full time- ...Job Description Job Description Associate Director, Regulatory Affairs Location: Boston, MA (Hybrid or East Coast, USA) Employment Type: Full-time, Permanent... ...guidance across multidisciplinary teams including CMC, clinical, and nonclinical functions. Monitor...Permanent employmentFull time
$241k - $332k
About This Role:As the Head of Regulatory CMC - Biologics & Advanced Therapy Medicinal Products... ...and supply continuity.This is a hybrid role to be based at our Headquarters in... ...agencies.Active engagement in major industry associations, conferences and forums.Strong...Full timeTemporary workLocal area$182k - $275k
...high-quality, science-based, and compliant regulatory CMC deliverables for assigned program(s), in... ...established by Global Regulatory Affairs and Technical Operations.This individual... ...Boston, Massachusetts. Rhythm operates in a hybrid-work model. Candidates applying must be...Work at office$204k - $245k
...Director, Regulatory CMC Somerville, MA At Genetix Biotherapeutics every role has meaning, every... ...activities. This is a full-time hybrid position (3 days a week) in our Somerville... ...relevant experience in CMC regulatory affairs for biologics or gene therapy products...Full timeWork at officeFlexible hours3 days per week$170k - $230k
Associate Director, Regulatory Affairs CMC Waltham, MA Skyhawk Therapeutics is seeking a hands‑on Associate Director, Regulatory Affairs CMC (RegCMC) to support the development and execution of the global RegCMC strategy for Skyhawk's small molecule pipeline. Working...$136.51k - $204.77k
...Job Title: Associate Director, CMC Lead Introduction to role: Are you ready to lead early-stage... .... IND/IMPD Readiness: Lead CMC regulatory strategy; guide and contribute to authoring... ...what science makes possible. #LI-Hybrid Date Posted 04-Aug-2026...Hourly payTemporary work$142.5k - $256.5k
The Role:The Associate Director, Global Regulatory-CMC will be responsible for coordinating regulatory CMC activities for one or more products, depending on complexity, through all stages of a products lifecycle. The Associate Director will be responsible for developing...Permanent employmentFull timeWork at officeWork from home$174.5k - $274.23k
...bring life‑changing therapies to patients worldwide. The Director Regulatory Site CMC ensures efficient and compliant management of regulatory change... ...the world. This position is currently classified as “hybrid” following Takeda’s Hybrid and Remote Work policy. Takeda...Minimum wageTemporary workLocal areaRemote workWorldwide- ...Pharmaceuticals, Inc. is seeking an experienced Regulatory CMC professional to execute high-quality,... ...collaborates with Global Regulatory Affairs, Technical Operations, and Quality to... ...requirements. The role is based in Boston with a hybrid-work model and may require some travel....
- Genetix Biotherapeutics is looking for a Director, Regulatory CMC to lead global regulatory strategies... ...gene therapy products. This full-time hybrid position based in Somerville,... ...a strong background in CMC regulatory affairs, demonstrating exceptional communication...Full time
$159k - $195k
...LinkedIn and Facebook. Role Summary: The Associate Director, Regulatory Chemistry Manufacturing and Control (CMC) is accountable for executing global CMC... ...proactively mitigate risks Serves as the Regulatory Affairs CMC representative in functional and team...Local area$154.4k - $242.55k
...strategies to maximize global regulatory success towards achievement... ....Accountabilities:The Associate Director will be responsible for complex... ...concepts within regulatory affairs and implications across the... ...is currently classified as “hybrid” in accordance with Takeda’s...Minimum wageTemporary workLocal areaRemote work$170.9k - $231.3k
OverviewThe Associate Director of Regulatory Affairs Strategy will serve as US Regional Lead or Global Regulatory Lead for our early/mid/late-stage CNS... ...regulatory intelligence for the internal teams.This is a hybrid role with a 2 day a week onsite presence in either...Full timeTemporary workLocal areaFlexible hours2 days per week$195k - $215k
...platform is centered on Receptor Associate Proteins (RAPs). RAPs are a... ...highly motivated Associate Director to join its CMC (Chemistry, Manufacturing,... ...implementation, and regulatory ready control strategies to... ...taking advantage of a more hybrid work schedule in Boston - we...Full timeWork at officeLocal areaImmediate start$129k - $203.1k
...critical data assets across the Pharmaceutical CMC (Chemistry, Manufacturing, and Controls)... ...by their ability to synthesize regulatory-compliant business policies and operational... ...: 10% Flexible Work Arrangements: Hybrid Shift: Not Indicated Valid Driving...Full timeFor contractorsLocal areaRelocationVisa sponsorshipFlexible hoursShift work$174.8k - $262.2k
...DescriptionGeneral Summary:Biostatistics Associate Director will perform sophisticated scientific... ...company's Global Medicines Development and Affairs area with minimal guidance and... ...1(k) and so much more.Flex Designation:Hybrid-Eligible Or On-Site EligibleFlex Eligibility...Full timeSummer workRemote workFlexible hours2 days per week- Job DescriptionGeneral Summary:The Associate Director, Medical Writing Science manages the overall... ...for document development for regulatory filings and coordinates the clinical sections... ...those of other departments.This is a hybrid role which allows for 2 days per week...Full timeWork experience placementSummer workWork at officeRemote workRelocation packageFlexible hours2 days per week3 days per week
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