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
$174.5k - $274.23k
A leading biopharmaceutical company is seeking a Director Regulatory Site CMC in Boston, MA. The role focuses on regulatory change control and post... ...in global HA requirements and regulatory strategy. This hybrid position offers a competitive salary range between $174,50...$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- ...franchise at CRISPR. Reporting to the Head of Regulatory Affairs, you will work closely with cross-... ...to patients. As the Regulatory CMC lead for these programs, you will have... ...record of significant accomplishments: ~ Associate Director: ~12+ Years of relevant experience...Contract workRemote work
- ...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...
- ...The Associate Director of Regulatory Affairs CMC will be responsible for developing, implementing and advising on global Regulatory CMC strategies for new and late stage programs to secure approval of the manufacturing process and control testing for initial clinical...
$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$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- ...Pharmaceuticals Inc. in Needham/Boston, MA, is seeking an Associate Director/Director of Development Program Management, CMC, to lead strategic and operational planning for... ...dashboards, and risk logs, and drive governance. Hybrid work with some travel required; compensation...Remote job
- Biogen, Inc. seeks an experienced CMC Asset Lead at Associate Director level to guide end-to-end asset leadership for clinical programs. You will chair... ...development, manufacturing, quality, supply chain and regulatory CMC, driving strategic planning and risk management in...
$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- ...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
$204k - $245k
...Director, Regulatory CMC Somerville, Massachusetts About Genetix Biotherapeutics At Genetix... ...compliance activities. This is a full-time hybrid position (3 days a week) in our... ...relevant experience in CMC regulatory affairs for biologics or gene therapy products...Full timeWork at office3 days per week$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- 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
- ...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....
$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$170.9k - $231.3k
OverviewThe Associate Director of Regulatory Affairs Strategy will work on assigned programs with the respective Global Regulatory Portfolio Lead, Global... ...intelligence for the internal teams.This is a hybrid role with onsite presence 2 days a week in either Cambridge...Full timeTemporary workLocal areaWorldwideFlexible hours2 days per week$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$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
$142.5k - $256.5k
Role Overview The Associate Director, Global Regulatory-CMC will coordinate regulatory CMC activities for one or more products throughout their lifecycle, develop global regulatory CMC strategies, collaborate with stakeholders, and manage multiple projects to support the...$163k - $225k
...PO&T) Division is looking to hire a CMC Asset Lead. This Associate Director level Asset Lead is a member of the... ...of corporate partners. This is a hybrid role based in Cambridge, MA. What You... ...chain, device (if applicable) and regulatory CMC, in the development of and delivery...Temporary workLocal area$275k - $315k
...seeking a strategic and experienced Senior Director of Regulatory Affairs to lead and execute US regulatory... ...based in our Boston office and follows a hybrid schedule, with three in-office days... ...functional teams (Clinical, Nonclinical, CMC, Biostatistics, Clinical Operations,...Full timeTemporary workWork at officeLocal area3 days per week- ....comLocation: Watertown, MA - Hybrid, 2-3 days/week onsiteReports to... ...individual will lead regulatory strategy and execution for growing... ...Development, Clinical Operations, CMC, Quality, and external regulatory... ..., and help build Regulatory Affairs capabilities as the clinical...2 days per week3 days per week
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