Global Regulatory Affairs CMC Director - Lead Submissions
$177k - $278.08kDormont Manufacturing Co
Takeda in Boston, MA, is looking for a Regulatory CMC Lead with extensive experience in biopharmaceuticals to develop regulatory strategies and manage global submissions. The ideal candidate possesses 10+ years in the field and strong leadership skills. This hybrid position offers a competitive salary ranging from $177,000 to $278,080, along with comprehensive benefits such as insurance and retirement plans. #J-18808-Ljbffr Dormont Manufacturing Co
$137k - $215.27k
...looking for a professional in Boston, MA, to contribute to Global Regulatory Affairs CMC. The role requires 6+ years of regulatory CMC or Device... ...Responsibilities include executing regulatory strategies and managing submissions. The position offers a hybrid work model, with a salary...Suggested$137k - $215.27k
Takeda is seeking a Regulatory Affairs professional in Boston, MA to lead regulatory CMC initiatives for various pharmaceutical products. The role requires a minimum... ...principles. You will manage regulatory submissions and foster relationships with health authorities...Suggested$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 experience with a strong focus on leading major submissions and ensuring regulatory compliance. This position...Suggested- Responsibilities Lead development and implementation of regulatory strategies for pure device and... ...Maintain and communicate CMC/quality guidance and regulations... ...matter expert for global Human Factors regulation... ...device-related global submissions and compliance activities...SuggestedNight shift
$212k - $333.19k
...to patients worldwide. As Senior Director and Regulatory Platform Lead GRA CMC, Device and Drug‑Device... ...prospective and proactive implementation. Globally influence and serve as a key... ...related aspects of global regulatory submissions (e.g., Core Dossiers, INDs, CTAs,...SuggestedMinimum wageFull timeTemporary workLocal areaWorldwideNight shift- ...seeking a seasoned professional for a role in Global Regulatory Affairs, focusing on Chemistry Manufacturing & Controls. The successful candidate will lead the development of regulatory CMC strategies and manage submissions critical to product lifecycle. Applicants must...
- A leading pharmaceutical company is looking for a Director of Regulatory Affairs to provide strategic and operational leadership in developing... ...will prepare regulatory submissions, interact with health... ...vital for supporting ongoing global clinical studies. #J-18808-Ljbffr...
- ...Executive Director, Global Regulatory Affairs Cmc Early Development Are you looking for a patient-focused... ...global Cmc regulatory strategies and submissions for small molecule and biologic products... ...China). Accountabilities Leads and develops a team of regulatory...
$238k - $374k
...Executive Director, Global Regulatory Affairs CMC Early Development Join us as Executive Director, Global Regulatory... ...CMC regulatory strategies and submissions for small molecule and biologic... ...across major regions. Responsibilities Lead and develop a team of regulatory...Temporary workLocal areaRemote work- Dormont Manufacturing Co is seeking a Regulatory Affairs professional in Boston, MA. The role focuses on executing regulatory strategies and... ...over 10 years of experience, including leadership in regulatory CMC. We offer a competitive salary range and comprehensive...
$137k - $215.27k
...worldwide. This role is within the Global Regulatory Affairs (GRA) Chemistry Manufacturing & Controls (CMC) and Devices organization, and... ...: With some supervision, leads the execution of regulatory... ...development of robust and accurate submissions. Develops constructive...Minimum wageFull timeTemporary workLocal areaRemote workWorldwide$238k - $374k
...patients worldwide. As Executive Director, Global Regulatory Affairs CMC Devices and Drug‑Device Combination... ...China). How you will contribute Leads and develops a team of regulatory leaders... ...regulatory strategy and major submissions for an assigned portfolio of medical...Temporary workWork at officeLocal areaRemote workWorldwide$142.5k - $256.5k
The Role: The Associate Director, Global Regulatory-CMC will be responsible for coordinating regulatory... ...CMC regulatory strategies for global submissions (e.g. IND/CTA/BLA/MAA) and identify... ...conform to health authority guidelines Lead Regulatory CMC discussions and...Permanent employmentWork at officeWork from home$154.4k - $242.55k
...worldwide. This role is within the Global Regulatory Affairs (GRA) Chemistry Manufacturing & Controls (CMC) and Devices organization, and... ...supervision, develops and leads the execution of regulatory... ...of robust and accurate submissions. Develops constructive relationships...Minimum wageTemporary workLocal areaRemote workWorldwide- Takeda is seeking a Senior Director, Global Regulatory Lead for Oncology in Boston, MA. This role involves leading global regulatory strategy for... ...projects, with responsibilities that include overseeing FDA submissions and ensuring compliance with regulatory requirements....
- ...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...
$177k - $278.08k
...patients worldwide. Join Takeda as a Director, Global Regulatory Lead Oncology where you will be part of... ...regulatory strategy and lead major submissions for high‑impact oncology programs.... ...understanding broad concepts within regulatory affairs and implications across the...Minimum wageFull timeTemporary workLocal areaWorldwide$212k - $333.19k
...worldwide. Join Takeda as a Senior Director, Global Regulatory Lead - Oncology, where you will be part of... ...manner. Accountable for US FDA submissions and approvals of project(s) of responsibility... ...broad concepts within regulatory affairs and implications across the...Minimum wageTemporary workLocal areaWorldwide$208.2k - $327.14k
A leading global R&D organization is seeking a Senior Director, Global Regulatory Lead - Oncology. This role involves leading global regulatory strategy and engaging with... ...including a strong background in regulatory submissions. The position is based in Boston, MA, and...- ...Rosa Therapeutics is seeking a Regulatory Operations Manager in Boston,... ...with proficiency in eCTD submissions and vendor oversight. The candidate... ..., maintain compliance with global standards, and prepare... ...position offers an opportunity to lead cross-functional teams and contribute...
- Takeda Pharmaceuticals International GmbH is seeking a Director, Regulatory Site CMC based in Cambridge, MA. This full-time position with a hybrid... ...managing post-approval changes, collaborating with teams globally, and promoting efficient regulatory operations. #J-18808...Full time
- ...biopharmaceutical company in Boston is seeking a Regulatory Affairs Specialist to coordinate the preparation of regulatory submission packages. The ideal candidate will have at... ...drugs, and a strong understanding of CMC requirements. Key responsibilities include managing...
$177k - $278.08k
Takeda is seeking a Director, Global Regulatory Lead Oncology to oversee regulatory activities for oncology programs in Boston, MA. This role involves managing FDA submissions and setting global regulatory strategies. Ideal candidates will have 8+ years of pharmaceutical...- ...biotechnology company in Boston is seeking a Regulatory Affairs professional to coordinate and prepare document packages for regulatory submissions. The role involves providing regulatory... ...Affairs experience, particularly with CMC requirements for Small Molecule drugs....Work at office
- Page Mechanical Group, Inc. is looking for an Executive Director of Regulatory Operations and Submission Management. This strategic role oversees the global regulatory processes ensuring high-quality submissions and compliance across the product lifecycle. The ideal candidate...
$204k - $245k
...challenge with radical care. The Director, Regulatory CMC is responsible for leading execution of global CMC regulatory strategies for... ...in supporting post-approval submissions, inspection readiness, and... ...experience in CMC regulatory affairs for biologics or gene therapy...Full timeWork at officeFlexible hours3 days per week$174.5k - $274.23k
A leading biotechnology company is seeking a Director, Global Regulatory Lead, GI & Inflammation. The role involves defining global regulatory strategies, leading teams... ..., with a strong background in regulatory affairs. This position is classified as hybrid, offering...$238k - $374k
...JobRx, Inc. is seeking an Executive Director of Global Regulatory Affairs in Boston, MA. This leadership role requires over 20 years of industry experience, with significant expertise in regulatory submissions for medical devices and combination products. You will oversee...$224.9k - $404.6k
Initial Therapeutics, Inc. is seeking a CMC Regulatory Manager based in Norwood, MA. The role involves leading a team of CMC experts to develop and implement regulatory strategies, ensure submission readiness, and manage interactions with health authorities. Ideal candidates...- Allergan is seeking a Director of Regulatory Affairs to develop and implement global regulatory strategies to secure product approvals. The role involves leading the Global Regulatory Product Team and requires strong leadership experience within the pharmaceutical sector...
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