Global Regulatory CMC Senior Manager — Submissions
BioSpace
Takeda in Boston, MA, seeks an experienced Regulatory CMC professional to lead submission planning and execution for clinical and post‑marketing programs. You will work with global teams to align regulatory strategy with product development goals. The role emphasizes regulatory intelligence, risk assessment, and coordination with Health Authorities, with mentorship and collaboration across functions to drive timely approvals. #J-18808-Ljbffr BioSpace
- ...America Pharmaceutical Inc. is seeking a Senior Manager for Quality Control (Biologics) to... ...while ensuring compliance with cGMP and regulatory standards. This pivotal role involves overseeing... ...QC and a proven track record with global regulatory filings. #J-18808-Ljbffr...SeniorRegulatoryContract work
- ...Inc. is seeking a seasoned professional for a role in Global Regulatory Affairs, focusing on Chemistry Manufacturing &... ...successful candidate will lead the development of regulatory CMC strategies and manage submissions critical to product lifecycle. Applicants must hold a...SeniorRegulatory
- SoTalent seeks a Senior Manager, Global Regulatory Affairs (CMC) to drive regulatory strategy and submissions for clinical development and post-approval. The role collaborates with development, QA, analytical, and manufacturing teams, ensuring alignment with global requirements...Regulatory
- ...seeking an experienced Associate Director / Director in Global Regulatory Affairs CMC to lead regulatory strategy and execution. This role involves... ...for complex pharmaceutical products and guiding major submissions. The ideal candidate will have over 10 years of experience...Regulatory
- ...Katalyst CRO in Boston is seeking a Regulatory Affairs professional to lead CMC strategies for investigational products. The candidate will interact with Health Authorities and manage regulatory submissions to ensure compliance and success. With a foundation in regulatory...SeniorRegulatory
$137k - $215.27k
...role This role is within the Global Regulatory Affairs (GRA) Chemistry Manufacturing & Controls (CMC) and Devices organization, and... ...of robust and accurate submissions. Develops constructive relationships... ..., plans, executes and manages regulatory submissions according...SeniorRegulatoryMinimum wageFull timeTemporary workLocal areaWorldwide- A leading biotechnology company in Boston is seeking a Senior Manager for Regulatory Affairs Operations. In this hybrid role, you will lead global regulatory submissions and collaborate across teams to ensure timely delivery of regulatory documents. The ideal candidate...SeniorRegulatory
- Cardinal Health is seeking a Scientist III CMC to lead regulatory strategy for client Rx and non-Rx programs. This senior-level role requires the ability to develop regulatory... ..., and provide strategic input on complex submissions. The successful candidate will also mentor...SeniorRegulatoryRemote job
$177k - $278.08k
JobRx, Inc. is seeking a Regulatory Affairs professional in Boston, MA to manage regulatory CMC strategy for pharmaceutical products. The role requires 10+ years of... ...with a strong focus on leading major submissions and ensuring regulatory compliance. This position...Regulatory- Takeda is seeking a Director Regulatory Site CMC in Boston, MA, to lead regulatory change management activities and ensure compliance with global HA requirements. The ideal candidate has over 10 years of biopharmaceutical/device industry experience and a strong understanding...Regulatory
- ...Massachusetts is seeking a Director, CMC QA responsible for quality... ...(cGMPs) and effective vendor management. The ideal candidate will... ...QA environment and support global clinical development programs... ...through robust quality systems and regulatory adherence. #J-18808-Ljbffr...Regulatory
- ...Job Description The Senior Manager Regulatory Affairs, Chemistry, Manufacturing and Controls (CMC) works with internal and external... ...strategy for regulatory submissions, including INDs/CTAs and amendments... ...as product development, Global Regulatory Product Teams and...SeniorRegulatoryWork at officeLocal areaRemote work
$100.5k - $145.17k
Job Title: Global Submission Manager Location: Morristown, NJ About the job The Global Submission Manager applies global expertise in managing... ..., from standard to complex. Represent GRO on Global Regulatory Teams (GRTs) for assigned products, per the GRA BluePrint...Regulatory$245k - $335k
A biopharmaceutical company in Cambridge is seeking a Senior Director of Global Quality Control. The role involves leading the global QC function across an outsourced model, ensuring compliance with regulatory standards, and providing strategic oversight for QC activities...SeniorRegulatory- Vertex Pharmaceuticals in Boston seeks a Senior Director, Quality Systems to lead quality management and systems across global operations. The ideal candidate will have a strong background in regulatory compliance, operational excellence, and quality oversight. This role...SeniorRegulatory
$270k - $285k
...Somerville, Massachusetts, is looking for a Senior Director, Regulatory CMC. This role is pivotal in defining and executing global CMC regulatory strategies for gene therapy... ...driving CMC activities, regulatory submissions, and mentoring team members. The ideal candidate...SeniorRegulatoryFull time- ...Partner in Boston, MA, to serve as a Workforce Capability Architect for the global QMS. This role involves designing training processes, developing role-based training models, and ensuring regulatory compliance across quality systems. Ideal candidates will have 8-12 years...SeniorRegulatory
- ...Executive Director of Chemistry, Manufacturing, and Control for Biologics to manage CMC professionals and ensure compliance with global regulatory strategies. This senior role involves overseeing submissions for high-quality CMC for biologics products and requires extensive...SeniorRegulatory
- Travere Therapeutics is looking for a Senior Manager in CMC Regulatory Affairs to provide strategic regulatory leadership in... ...biologics. This role involves developing global CMC regulatory strategies, managing submissions, and working closely with cross-functional teams...SeniorRegulatoryRemote job
- Takeda is seeking an experienced Regulatory CMC Leader in Boston to independently develop regulatory CMC strategy and lead regulatory submissions across the product lifecycle. You will partner with regulatory, development, and commercial teams to drive compliant, timely...Regulatory
$250k - $280k
...Talent Solutions has been retained by a global biopharmaceutical company specializing in... ...recruit a Global Market Access Director/Senior Director. This position reports to the... ...working cross‑functionally with Medical, Regulatory, and Commercial teams. Develop and steer...SeniorRegulatoryTemporary workWork at officeWork from homeWorldwide- Title: Director / Senior Director, Global Regulatory Lead Location: San Francisco, CA or Boston, MA -> hybrid... ...in leading the company’s first NDA submission and partnering closely with... ...Partner cross-functionally with Clinical, CMC, Commercial, and Executive Leadership...SeniorRegulatoryRelocation3 days per week
- Regulatory Affairs CMC, Manager/Senior Manager Currently partnering with a public Biotech who are currently expanding... ...CMC Manager to support the global development and registration of biologic... ...as they prepare for a BLA submission. Key Responsibilities Lead the preparation...SeniorRegulatory
- Senior Manager, Global Regulatory Affairs (CMC) | Regulatory Strategy | CMC Submissions | Pharmaceutical R&D Role Overview Senior regulatory role within global R&D (Chemistry, Manufacturing & Controls - CMC) Responsible for executing regulatory strategy across clinical...SeniorRegulatory
- ...of Aktis’ proprietary pipeline. The Senior Manager, Global Radiopharmaceutical Manufacturing, leads... ...regulations, and applicable global regulatory requirements. Support audits,... ...manufacturing input into regulatory submissions, including IND/IMPD updates and responses...SeniorRegulatoryContract work
$134.62k - $201.25k
The Senior Manager, Quality Control (Biologics) will execute... ...product meets cGMP, regulatory, and company standards... ...integrity. It also supports global regulatory filings (... .../MAA) by delivering submission‑ready analytical... ...and review Module 3 (CMC) sections, ensuring alignment...SeniorRegulatoryContract workTemporary workLocal areaFlexible hours$134.62k - $201.25k
The Senior Manager, Quality Control (Small Molecules) will... ...product release, and regulatory compliance. This role... ...during FDA, EMA, and global authority inspections.... ...ANDA, and post‑approval submissions through preparation, review... ...Manufacturing, QA, CMC, Regulatory Affairs, and...SeniorRegulatoryContract workTemporary workLocal areaFlexible hours$129.4k - $194.2k
...Workforce Capability Architect for the global QMS, responsible for designing how processes... ...with documentation, systems, and change management. Responsibilities Process-to-... ...prevent disconnect from executable tasks or regulatory requirements and eliminate redundant or...SeniorRegulatoryRemote work2 days per week- Responsibilities Lead the global occupational and environmental toxicology strategy across... ..., hazardous waste, and chemical management. Assist in the development of an Industrial... ...Serve as a technical representative during regulatory inspections, client audits, due...SeniorRegulatory
$245k - $335k
...high unmet need. As a global leader in the biology of... ...experienced and motivated Senior Director of Global... ...specification lifecycle management, and stability. Provide... ...Analytical Development and CMC teams to support method... ...expectations, and regulatory obligations (FDA, EU, and...SeniorRegulatoryContract work
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Global Regulatory CMC Senior Manager — Submissions. Be the first to apply!
- compliance director Boston, MA
- director quality compliance Boston, MA
- healthcare compliance manager Boston, MA
- quality regulatory manager Boston, MA
- regulatory affairs manager pharmaceutical Boston, MA
- senior director regulatory affairs Boston, MA
- senior regulatory manager Boston, MA
- quality compliance manager Boston, MA
- sr. manager regulatory compliance Boston, MA
- corporate compliance manager Boston, MA


