CMC Regulatory Science Director - Global Submissions Lead
Moderna Therapeutics
Moderna Therapeutics in Norwood, MA is seeking a Regulatory CMC Lead to manage a team of CMC experts. This role involves overseeing regulatory strategies for a portfolio of products, ensuring compliance with health authority guidelines, and leading interactions with regulators. The ideal candidate will have a MS/PhD degree in a relevant field, extensive experience in the pharmaceutical industry, and a strong background in regulatory CMC. Enjoy a comprehensive benefits package including best-in-class healthcare coverage. #J-18808-Ljbffr Moderna Therapeutics
$142.5k - $256.5k
...The Role The Associate Director, Global Regulatory, CMC will be responsible for... ...regulatory strategies for global submissions (e.g. IND/CTA/BLA/MAA) and... ...authority guidelines Lead Regulatory CMC discussions... ...have been recognized as a Science Magazine Top Biopharma...SuggestedPermanent employmentWork at officeWork from home$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$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- A leading biopharmaceutical company is seeking a Director of Regulatory CMC in Boston, MA. This key role involves managing post-approval change activities, ensuring compliance with global regulations, and leading efforts to standardize processes. Candidates should possess...Suggested
- Takeda in Boston is looking for a GRA CMC Product Lead to oversee regulatory CMC strategies and lead submissions for investigational, registration, and post-approval processes. This role requires a strong background in biopharmaceuticals with 10+ years in the industry...Suggested
$137k - $215.27k
...This role is within the Global Regulatory Affairs (GRA) Chemistry Manufacturing & Controls (CMC) and Devices organization, and... ...follows: With some supervision, leads the execution of regulatory CMC... ...development of robust and accurate submissions. Develops constructive...Minimum wageFull timeTemporary workLocal areaImmediate startRemote workWorldwide$177k - $278.08k
...worldwide. This role is within the Global Regulatory Affairs (GRA) Chemistry Manufacturing & Controls (CMC) and Devices organization, and... ...regulatory CMC strategy and leads the execution of regulatory... ...of global registrational submissions of complex drug product or suite...Minimum wageFull timeTemporary workLocal areaRemote workWorldwide$238k - $374k
...patients worldwide. As Executive Director, Global Regulatory Affairs CMC Early Development you will provide... ...How you will contribute: Leads and develops a team of regulatory leaders... ...CMC regulatory strategy and key submissions/health authority interactions for...Minimum wageFull timeTemporary workLocal areaRemote workWorldwide- ...Role This role is within the Global Regulatory Affairs (GRA) Chemistry Manufacturing & Controls (CMC) and Devices organization, and... ...the regulatory CMC strategy and leads the execution of regulatory... ...aspects of global registrational submissions of complex drug product or...Full timeLocal areaWorldwide
- ...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...
$212k - $333.19k
...patients worldwide. As Senior Director and Regulatory Platform Lead GRA CMC, Device and Drug-Device... ...implementation. Globally influences and serves as... ...aspects of global regulatory submissions (e.g., Core Dossiers,... ...expertise with proposing science-based, data-driven regulatory...Minimum wageFull timeTemporary workLocal areaRemote workWorldwideNight shift$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$212k - $333.19k
...impact on patients worldwide. Join Takeda as a Senior Director, Global Regulatory Lead – Oncology, where you will be part of the global... ...professional and timely manner. Accountable for US FDA submissions and approvals of project(s) of responsibility. May serve...Minimum wageFull timeTemporary workLocal areaRemote workWorldwide$177k - $278.08k
...lasting impact on patients worldwide. Join Takeda as a Director, Global Regulatory Lead Oncology where you will be part of the global regulatory... ...you will set global regulatory strategy and lead major submissions for high-impact oncology programs. How you will...Minimum wageFull timeTemporary workLocal areaRemote workWorldwide$177k - $278.08k
...Purpose: Defines, develops and leads global strategies to maximize global regulatory success towards achievement of... .... Accountabilities: The Director will be responsible for complex... .... Accountable for all US FDA submissions and approvals of project(s) of responsibility...Minimum wageFull timeTemporary workLocal areaRemote work$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...- ...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...
$211.58k - $317.37k
...strategically focussed Regulatory professional... ..., confident to lead, willing to... ...about what science can do, then you... ...Regulatory Affairs Director (SRAD) serves... ...the Franchise Global Regulatory Lead... ...emerging markets, RA CMC, Labelling and members of the submission and execution...Hourly payFull timeTemporary workWork at officeWork from homeWorldwide2 days per week3 days per week- ...Global Regulatory Strategy Lead Act as responsible for establishment of Global Regulatory strategy and... ...create high quality global regulatory submissions that support development strategies for... ...requirements (e.g., PIP/PSP, CMC…) to support global development and regulatory...
$210k - $235k
...At Vor, we believe science can do more than... ...preferred The Senior Director/ Director Regulatory Strategy provides global regulatory... ...Clinical, Quality, CMC, Commercial, and represents... ...~ Develop and lead global, integrated... ...of regulatory submissions. ~...Remote workWorldwideFlexible hours- ...experienced and strategic Director of Regulatory Affairs to lead and support global regulatory efforts... ...background is preferred. CMC experience is a plus.... ...Lead the preparation, submission, and maintenance of regulatory... ...'s degree in health sciences or related field, or an...
$177k - $278.08k
...worldwide. The Director Regulatory Site CMC ensures efficient and... ...experience with global HA requirements, beyond... ...will contribute: Lead site-specific post-approval... ...and regulatory submissions (considering... ...requirements. Apply science- and risk-based approaches...Minimum wageFull timeTemporary workLocal areaRemote workWorldwide- Monte Rosa Therapeutics, Inc is seeking a Director of Regulatory Affairs based in Boston. This... ...executing regulatory strategies to support global product development, particularly in immunology... ...and the ability to manage regulatory submissions and work with health authorities such...
- ...Description: 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...
$150.03k - $224.25k
...critical support in developing global regulatory strategy, planning and... ...marketed prescription drug submissions and manages lifecycle activities... ...with the Global Regulatory Lead. Translates complex pertinent... ...team (GRL, regional leads, CMC-RA, labeling, medical writing...Temporary workWork at officeLocal areaFlexible hours- 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...
$196k - $269.5k
...that maintains its roots as a science-based start-up and pushes our... ...our ambitions, the argenx Global Commercial Team is looking for a Director, Global Indication Lead, Rheumatology. In this key... ...understanding of the legal, regulatory and commercial environment across...Temporary workWork at officeRemote work$285k - $350k
...asset-centric model can lead to improved success... ...The Executive Director, Regulatory CMC will provide strategic leadership for global CMC regulatory activities... ...overseeing high-quality submissions, and ensuring... ...chemistry, pharmaceutical sciences, or a related scientific...Full time- A leading global biopharmaceutical company is seeking a Director of Global Regulatory Affairs. This role is pivotal in developing innovative regulatory strategies for various... ...leading regulatory teams, managing FDA submissions, and ensuring compliance across multiple projects...
$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...
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