Senior Regulatory CMC Director
Rhythm Pharmaceuticals, Inc
Rhythm Pharmaceuticals, Inc. is seeking an experienced Regulatory CMC professional to execute high-quality, compliant CMC deliverables for assigned programs. This individual contributor role collaborates with Global Regulatory Affairs, Technical Operations, and Quality to ensure timely, complete submissions and alignment with global requirements. The role is based in Boston with a hybrid-work model and may require some travel. #J-18808-Ljbffr Rhythm Pharmaceuticals, Inc
$195k - $330k
...ll make an impact:Lead the development and execution of global regulatory CMC strategies for degrader programs across all stages of... ...amendments/supplements.Provide strategic regulatory CMC guidance to senior leadership regarding health authority interactions, submission...Senior$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. It can change the course of disease. By advancing telitacicept, a first‑and potentially best‑in‑class dual BAFF/APRIL...SeniorContract workWorldwideFlexible hours$163.5k - $281.6k
.... Responsibilities Develop and implement comprehensive global regulatory CMC strategies for assigned gene therapy programs, including IND/CTA... ...strategies and providing strategic recommendations to senior leadership. Stay current with evolving global regulatory requirements...SeniorFull timeFor contractorsWork at officeFlexible hours- Job-ID32387836Reference26-00886 Job Description: This role is within the Global Regulatory Affairs (GRA) Chemistry Manufacturing & Controls (CMC) and Devices organization, and will contribute to the team's delivery of critical functions as follows: This role is within...Senior
$195k - $330k
...an impact:Act as the global regulatory strategy lead for Kymera’s IRF... ...working closely with Clinical, CMC, Nonclinical, Quality, and... ...recommendations to program teams and senior leadership.Manage and support... ...preferred but not required.Director: 8-10 years of Regulatory...SeniorFlexible hours$275k - $315k
...OverviewBicara Therapeutics is seeking a strategic and experienced Senior Director of Regulatory Affairs to lead and execute US regulatory strategy for our... ...guidance to cross-functional teams (Clinical, Nonclinical, CMC, Biostatistics, Clinical Operations, Medical Affairs, and...SeniorFull timeTemporary workWork at officeLocal area3 days per week$218.06k - $327.09k
Job Title: Senior Director, Regulatory Affairs Strategy - Cell Therapy Available locations: Gaithersburg, MDBoston, MASouth San Francisco, CASanta... ...presentations and aligning regulatory objectives with clinical, CMC, safety and commercial strategies.Evidence and Decision-...SeniorHourly payFull timeTemporary workStart working todayWork at officeFlexible hours3 days per week- Senior Manager - Regulatory Affairs Operations Location - Cambridge, MA (Hybrid) Oncology Biotech | Global... .... The Role Reporting into the Director of Regulatory Affairs Operations, you... ...functionally with Regulatory Strategy, Clinical, CMC, and external partners to ensure...Senior
$182k - $275k
...overcome barriers, together.Opportunity OverviewThis role is responsible for executing high-quality, science-based, and compliant regulatory CMC deliverables for assigned program(s), in alignment with strategies established by Global Regulatory Affairs and Technical...Work at office$241k - $332k
About This Role:As the Head of Regulatory CMC - Biologics & Advanced Therapy Medicinal Products (ATMP), you will lead a dynamic team within the PO&T function, driving the regulatory strategy for biologics and ATMPs in Biogen’s portfolio. Your role encompasses global, regional...Full timeTemporary workLocal area$177k - $278.08k
...possible in order to bring life-changing therapies to patients worldwide.This role is within the Global Regulatory Affairs (GRA) Chemistry Manufacturing & Controls (CMC) and Devices organization, and will contribute to the team’s delivery of critical functions as follows...Minimum wageTemporary workLocal areaRemote workWorldwide$190.4k - $285.6k
Job DescriptionGeneral Summary:The Director, Chemistry Manufacturing Controls (CMC) leads a Regulatory CMC team responsible for developing and executing global regulatory... ...to cross-functional stakeholders.Serves as senior Regulatory CMC representative on governance...Full timeSummer workRemote workFlexible hours2 days per week$238k - $374k
...true to the best of my knowledge.Job DescriptionExecutive Director, Global Regulatory Affairs CMC Early DevelopmentAre you looking for a patient-focused... ...principles.Represents Global Regulatory Affairs CMC in senior-level governance and in interactions with global health...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... ...regulations.Represents Global Regulatory Affairs in senior-level governance and in interactions with global...Minimum wageTemporary workWork at officeLocal areaRemote workWorldwide- Moderna is seeking a leader to manage a team of CMC experts in Norwood, MA, overseeing regulatory correspondence and applications, shaping product strategy, and guiding regulatory activities to produce high-quality CMC sections for submissions. You will lead interactions...
$204k - $245k
...Director, Regulatory CMC Somerville, Massachusetts About Genetix Biotherapeutics At Genetix Biotherapeutics every role has meaning, every team member is respected, and every day is a chance to make a difference. When you join Genetix, you're not just landing...Full timeWork at office3 days per week$210k - $235k
...across functions and geographies. The Director, Regulatory Strategy provides global regulatory leadership... ...partner to R&D, Clinical, Quality, CMC, Commercial, and represents the... ...Serve as a key regulatory advisor to senior leadership and cross‑functional governance...SeniorRemote workWorldwideFlexible hours- ...-ID31521196Reference25-04484 The Global Regulatory Affairs (GRA) is responsible for obtaining... ...Reg Nonclinical / Clinical Associate Director will lead, conceive, communicate and execute... ..., influence and negotiate with senior Nonclinical / Clinical leaders on product...Senior
$166.4k - $249.6k
Job DescriptionGeneral Summary:The Chemistry Manufacturing Controls (CMC) Associate Director leads and executes global regulatory CMC strategies across investigational and commercial products focusing on biologics. This role is accountable for authoring, reviewing, and...Full timeSummer workRemote workFlexible hours2 days per week- Job DescriptionGeneral Summary:The CMC Quality Compliance Director is responsible for inspection readiness and compliance of internal and external... ...manufacturing/testing sites. Monitor and interpret cGMP regulatory guidelines and trends in the regulatory space and...Full timeWork experience placementSummer workRemote workFlexible hours2 days per week
- ...options through rigorous science and a collaborative, mission-driven culture. Primary Responsibilities The Director/Senior Director, Regulatory CMC (Chemistry, Manufacturing, and Controls) is a pivotal regulatory role responsible for developing and executing...Remote workFlexible hours
- 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...
$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-approval activities, ensuring compliance across diverse modalities. Candidates should have over 10 years of experience in...- ...investments, we push the boundaries of what is possible in order to bring life‑changing 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....Local areaWorldwide
- 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...Full time
- Scorpion Therapeutics is seeking a senior Regulatory CMC leader to plan, prepare, and execute regulatory activities for small molecule and ASO programs, partnering with cross-functional teams and external vendors. The role focuses on IND/IMPD/NDA/BLA submissions, health...SeniorRemote job
- Biogen, Inc. seeks a Senior Manager, CMC Operations to oversee external development and manufacturing from IND-enabling studies through Phase 2 across multiple programs. You will serve as the CMC Pharma interface to CDMOs and partner with R&D, Quality, Supply Chain, and...Senior
$210k - $320k
...Overview:Beam is seeking a highly talented and motivated Sr. Director / Director of CMC, to lead our advancing portfolio of in-vivo and ex-vivo... ...analytical changes, and secondary suppliers.Work directly with regulatory and key stakeholders on the development and implementation...SeniorFull time- Centessa Pharmaceuticals in the US seeks a Senior Director of Drug Product in CMC to lead nonclinical and clinical formulation development and manage... ...oral, subcutaneous, and intravenous delivery, and guide regulatory documentation. #J-18808-Ljbffr Centessa...Senior
$12.08k - $14.58k
...What’s the opportunity? We are seeking a highly skilled Senior Manager/Associate Director, Regulatory Operations to support and help drive regulatory success... ...Affairs, Medical Writing, Clinical Development, CMC, Quality, and external partners to ensure high-quality,...SeniorShift work
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Senior Regulatory CMC Director. Be the first to apply!
- regulatory & compliance manager Boston, MA
- director global regulatory affairs Boston, MA
- head compliance Boston, MA
- senior director regulatory affairs Boston, MA
- associate director compliance Boston, MA
- compliance manager Boston, MA
- regulatory affairs director Boston, MA
- regulatory cmc manager Boston, MA
- regulatory affairs manager pharmaceutical Boston, MA
- compliance director Boston, MA


