Biologics CMC Regulatory Senior Director - Hybrid
Beeline Medicines Corporation
Beeline Medicines Corporation is seeking a Senior Director, Regulatory Affairs CMC – Biologics to lead the CMC regulatory strategy for monoclonal antibodies and other large molecules. You will drive submissions, interact with FDA/EMA, and align cross‑functional teams across Process Development, Analytical Sciences, and Quality to ensure regulatory compliance from IND/CTA through post‑approval lifecycle. The role demands 12+ years of CMC regulatory experience, advanced education in a #J-18808-Ljbffr Beeline Medicines Corporation
- 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...Senior
$242k - $313.5k
...mediated diseases can live life fully. Job Summary The Senior Director, Regulatory Affairs CMC - Biologics provides senior‑level scientific and strategic... ...regulatory infrastructure. Work Arrangement & Location Hybrid - This position follows a hybrid work schedule,...SeniorLocal areaFlexible hours2 days per week- Vor Bio seeks an exceptional and highly motivated Director/Sr Director Regulatory CMC to lead development and implementation of robust regulatory CMC... ...with a track record in regulatory submissions for biologics, strong interaction with FDA sCDER, and ability to guide...Senior
- Beeline Medicines is seeking a Senior Director, Regulatory Affairs CMC - Biologics to lead regulatory strategy for biologics assets from early development through BLA filing and post‑approval lifecycle management. You will collaborate with Process Development, Analytical...Senior
- Vertex is seeking an Associate Director of CMC to lead global regulatory strategies for biologics, author submissions, and interface with health authorities, leveraging... ...the ability to lead cross-functional teams in a hybrid Boston-area setting. #J-18808-Ljbffr Vertex...Suggested
$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... ...manufacturing readiness and supply continuity.This is a hybrid role to be based at our Headquarters in Cambridge, MA.What...Full timeTemporary workLocal area- Rhythm Pharmaceuticals, Inc. is seeking an experienced Regulatory CMC professional to execute high-quality, compliant CMC deliverables for... ...with global requirements. The role is based in Boston with a hybrid-work model and may require some travel. #J-18808-Ljbffr Rhythm...Senior
$166.4k - $249.6k
...Chemistry Manufacturing Controls (CMC) Associate Director leads and executes global regulatory CMC strategies across... ...commercial products focusing on biologics. This role is accountable for authoring... ...and so much more.Flex Designation:Hybrid-Eligible Or On-Site EligibleFlex...Full timeSummer workRemote workFlexible hours2 days per week$137k - $215.27k
...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...SeniorMinimum wageTemporary workLocal areaRemote workWorldwide- Regulatory Affairs CMC, Manager/Senior Manager Currently partnering with a public Biotech who are currently expanding and seeking an experienced Regulatory... ...to support the global development and registration of biologic products across all stages of the product lifecycle....Senior
$184.6k - $277k
...Description General Summary The CMC Quality Compliance Director is responsible for... ...Monitor and interpret cGMP regulatory guidelines and trends in the... ...more. Flex Designation Hybrid-Eligible Or On-Site Eligible... ...insight into causal human biology, including APOL1-mediated...Work experience placementSummer workRemote workFlexible hours2 days per week- A leading biotechnology company in Boston is seeking a Regulatory Strategy Senior Director to oversee global regulatory strategies for development programs... ...at least 12 years of relevant experience. This role is hybrid, requiring three days onsite per week. #J-18808-Ljbffr...Senior3 days per week
$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... ...agencies. Extensive experience in the development of biologics and combination biologic/device products is a must....SeniorContract workWorldwideFlexible hours$147.5k - $221.3k
...General Summary: The Associate Director, CMC Quality Compliance and... ...Knowledge and Skills: Knowledge of regulatory requirements and inspection... ...travel possible. Hybrid-Eligible Roles: In this Hybrid... ...deep insight into causal human biology, including APOL1-mediated kidney...Summer workRemote workFlexible hours2 days per week- Vertex Pharmaceuticals Incorporated is seeking an Associate Director of Chemistry Manufacturing Controls (CMC) to lead global regulatory strategies for biologics. You will author, review, and deliver high-quality regulatory submissions and serve as the primary CMC interface...
$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...$275k - $315k
...strategic and experienced Senior Director of Regulatory Affairs to lead and execute... ...regulatory strategy for our biologics pipeline. Reporting to the... ...Boston office and follows a hybrid schedule, with three in-office... ...(Clinical, Nonclinical, CMC, Biostatistics, Clinical Operations...SeniorFull timeTemporary workWork at officeLocal area3 days per week- Rhythm Pharmaceuticals Inc. in Boston, MA seeks an experienced Regulatory CMC professional to drive high-quality regulatory chemistry, manufacturing, and controls deliverables. You will support global filing strategies, coordinate with Global Regulatory Affairs, Technical...
$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 cutting... ...a scientific discipline (e.g., Biochemistry, Molecular Biology, Chemistry, Pharmacy, Chemical Engineering) is required...SeniorFor contractorsWork at officeFlexible hours- ...Job Description The Senior Manager Regulatory Affairs, Chemistry, Manufacturing and Controls (CMC) works with internal and external... ...to patients to deliver biologics products to patients, including... ...company. This role will work a hybrid work schedule (3 days in...SeniorWork at officeLocal areaRemote work
$190.4k - $285.6k
...DescriptionGeneral Summary:The Director, Chemistry Manufacturing Controls (CMC) leads a Regulatory CMC team responsible... ....Serves as senior Regulatory CMC representative... ...Degree in Chemistry, Biology, Pharmacy, Regulatory... ...more.Flex Designation:Hybrid-Eligible Or On-Site...Full timeSummer workRemote workFlexible hours2 days per week- ...Job Description Job Description Senior AI Scientist – Drug Discovery & Computational Biology (Hybrid - Boston, MA, USA) We are looking to hire a candidate with the mentioned skill sets and experience for one of our clients within the Healthcare Industry. This is...Senior
- EMD Serono, Inc. is seeking a Senior Director to lead a team in regulatory review of promotional materials for U.S. prescription drugs. This role ensures... ...of 10 years of relevant experience. Position offers a hybrid work model based in Boston, MA. #J-18808-Ljbffr EMD Serono...Senior
- Develop and implement comprehensive global regulatory CMC strategies for assigned gene therapy... ...providing strategic recommendations to senior leadership Stay current with evolving global... ...(e.g., Biochemistry, Molecular Biology, Chemistry, Pharmacy, Chemical Engineering...SeniorFor contractorsWork at office
- ...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
...every challenge with radical care. The Director, Regulatory CMC is responsible for leading execution... ...compliance activities. This is a full‑time hybrid position (3 days a week) in our... ...life sciences (biochemistry, chemistry, biology, biochemical engineering, or related field...Full timeWork at officeFlexible hours3 days per week$238k - $374k
...Job DescriptionExecutive Director, Global Regulatory Affairs CMC Early DevelopmentAre you... ...submissions for small molecule and biologic products through Phase 2... ...Affairs CMC in senior-level governance and in interactions... ...currently classified as “hybrid” in accordance with...Minimum wageTemporary workLocal areaRemote work- Vertex is seeking a Chemistry Manufacturing Controls Manager in Boston to lead regulatory CMC submissions for investigational and commercial products. You will partner with global teams to shape regulatory CMC strategies and coordinate responses with agencies. The role...Remote job
$174.5k - $274.23k
...therapies to patients worldwide. The Director Regulatory Site CMC ensures efficient and compliant management... ...—including small molecules, biologics, and external manufacturing sites—the... ...position is currently classified as “hybrid” following Takeda’s Hybrid and Remote...Minimum wageTemporary workLocal areaRemote workWorldwide$220k - $290k
...the U.S. and are exploring regulatory pathways for Europe and Japan... ...short and long‑term plans. The Senior Director, Regulatory Affairs has... ...which supports product (drugs, biologics and devices) development,... ...development program. Guide CMC, nonclinical and clinical personnel...SeniorTemporary workFor contractorsWork at officeWeekday work
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Biologics CMC Regulatory Senior Director - Hybrid. Be the first to apply!
- regulatory cmc manager Boston, MA
- regulatory operations manager Boston, MA
- regulatory manager Boston, MA
- director global regulatory affairs Boston, MA
- operations compliance manager Boston, MA
- manager regulatory affairs Boston, MA
- head compliance Boston, MA
- compliance manager Boston, MA
- compliance director Boston, MA
- senior director regulatory affairs Boston, MA


