Director, CMC Regulatory Strategy & Submissions
$207k - $253kMadrigalpharma
Madrigalpharma in Waltham is looking for a Director, Regulatory Affairs CMC to drive regulatory strategies for clinical trials and market approvals. Key responsibilities include leading CMC regulatory dossier development and engaging with Health Authorities. The ideal candidate has a BS in life sciences, over 12 years of experience including regulatory CMC, and excellent communication skills. This full-time role offers a salary between $207,000 and $253,000 annually, along with equity opportunities and competitive benefits. #J-18808-Ljbffr
$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$196k - $240k
...A biotechnology firm in Waltham, MA, is seeking a Director of Regulatory Affairs – CMC. This strategic role includes leading global regulatory strategies and mentoring team members. Candidates should have 10+ years of experience in biotech/pharmaceutical industries and...Suggested$172k - $187k
...Job Description Regulatory Affairs Chemistry, Manufacturing... ..., and Controls (CMC), plays a critical... ...experienced Associate Director, Regulatory Affairs CMC... ...Lead regulatory CMC strategy and execution for assigned... ..., review and submission of high-quality CMC sections...SuggestedWork at officeLocal area$207k - $253k
## Director, Regulatory Affairs CMCApplylocations: MA - Waltham - Officetime... ...strengthening our workforce strategy to ensure we have the right... ...and operational regulatory CMC leadership to support clinical... ...registrations and post-approval submissions, along with managing the day...SuggestedMinimum wageFull timeLocal areaFlexible hours$159k - $195k
...Role Summary: The Associate Director, Regulatory Chemistry Manufacturing and Control (CMC) is accountable for executing global CMC regulatory strategies for our programs in early and late... ...and management of global submissions, maintenance of product compliance...SuggestedLocal area$196k - $240k
...Facebook . Role Summary The Director, Regulatory Affairs – Chemistry, Manufacturing, and Controls (CMC) is responsible for defining... ...executing global CMC regulatory strategies for Dyne programs across all... ...aligned CMC regulatory submissions worldwide. The Director serves...Local areaWorldwide$160k - $196k
...Associate Director, Regulatory Operations Global Submission Management page is loaded## Associate Director, Regulatory... ...we are strengthening our workforce strategy to ensure we have the right talent... ...including Regulatory Strategy, CMC, Clinical, Labeling, and vendors to...Minimum wageFull timeLocal areaRemote workFlexible hours$170.9k - $231.3k
## Associate Director, Regulatory Affairs, CMCUnited StatesApply NowFind out... ..., Regulatory Affairs CMC Development is responsible... ...implementating global CMC regulatory strategies for development-stage... ...Experience with regulatory submissions and health authority interactions...Full timeTemporary workWork at officeLocal areaFlexible hours- ...Job Description As Executive Director, Global Regulatory Affairs CMC Early Development you will provide strategic... ...robust, fit‑for‑phase regulatory strategies for small molecule and biologic... ...CMC regulatory strategy and key submissions/health authority interactions for...Temporary workLocal area
$177k - $278.08k
...This role is within the Global Regulatory Affairs (GRA) Chemistry Manufacturing & Controls (CMC) and Devices organization, and... ...develops the regulatory CMC strategy and leads the execution of regulatory... ...of global registrational submissions of complex drug product or...Minimum wageTemporary workLocal areaRemote workWorldwide- ...experienced and strategic Director of Regulatory Affairs to lead and support... ...developing and executing regulatory strategies that support global product... ...background is preferred. CMC experience is a plus.... ...expectations. Lead the preparation, submission, and maintenance of...
- ...position is responsible for preparation of CMC submissions for Biologics products. This position will also assist the Regulatory CMC team with special projects as assigned. • Responsible for implementing regulatory strategies, including filing of all appropriate regulatory...
$187.5k - $275k
...for serious diseases. Regulatory affairs collaborates cross... ...successful regulatory strategies. Verve is located in... ...The Senior Director, Regulatory Affairs is... ...regulatory strategy, submissions, and compliance activities... ...clinical, nonclinical, and CMC regulatory strategy including...Full timeWork at officeFlexible hours3 days per week$177k - $278.08k
...This role is within the Global Regulatory Affairs (GRA) Chemistry Manufacturing & Controls (CMC) and Devices organization, and... ...develops the regulatory CMC strategy and leads the execution of regulatory... ...of global registrational submissions of complex drug product or...Minimum wageFull timeTemporary workLocal areaRemote workWorldwide$238k - $374k
...patients worldwide. As Executive Director, Global Regulatory Affairs CMC Devices and Drug-Device Combination... ...innovative and robust regulatory strategies for medical devices and drug-device... ...regulatory strategy and major submissions for an assigned portfolio of medical...Minimum wageTemporary workWork at officeLocal areaRemote workWorldwide$145k - $207k
...Associate Director, CMC Regulatory Cambridge, MA The Opportunity: As part of the Pharmaceutical... ...will play a key role in regulatory strategy development and execution of assigned... .... Develop and execute CMC global submission plans and timelines in accordance...$177k - $278.08k
...therapies to patients worldwide. The Director Regulatory Site CMC ensures efficient and compliant... ...understand and communicate regulatory strategy to drug development, registration, and... ...including record evaluations and regulatory submissions (considering possible strategic...Minimum wageFull timeTemporary workLocal areaRemote workWorldwide- ...is seeking a seasoned professional for a role in Global Regulatory Affairs, focusing on Chemistry Manufacturing & Controls... ...candidate will lead the development of regulatory CMC strategies and manage submissions critical to product lifecycle. Applicants must hold a BS...
- Noema Pharma is seeking a Director of Regulatory Affairs to lead the development and commercialization of products in clinical programs. This... ...pharmaceutical industry. The Director will develop regulatory strategies, interact with health authorities such as the FDA, and...Local area
- ...Description JOB TITLE: Executive Director, Regulatory Operations and Submission Management DEPARTMENT: Regulatory... ...Affairs, Medical Writing, CMC/Technical Operations, Quality, Clinical... ...and lead the Regulatory Operations strategy and execution to deliver compliant,...
- ...Reporting to the Head of Regulatory Affairs, you will work... .... As the Regulatory CMC lead for these... ...innovative Regulatory strategies where little precedent... ...accomplishments: Associate Director: 12+ Years of relevant... ...eCTD requirements for submission to US and ex-US regulatory...Full timeContract workRemote work
- ...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...
$212k - $333.19k
...to patients worldwide. As Senior Director and Regulatory Platform Lead GRA CMC, Device and Drug-Device... ...and combination product regulatory strategies particularly pertaining to the development... ...aspects of global regulatory submissions (e.g., Core Dossiers, INDs, CTAs,...Minimum wageTemporary workLocal areaRemote workWorldwideNight shift- ...Reporting to the Senior Director, Regulatory Affairs, the Associate Director... ...alignment with the corporate strategy for Viridian's Thyroid Eye Disease... ...and review regulatory submissions including INDs, CTAs, amendments... ..., work with Regulatory CMC and Regulatory Operations teams...Temporary workWork at officeLocal areaImmediate start3 days per week
$99.2k - $165.4k
Job Summary The Manager, Regulatory Program Management & Submission Strategy (RPMSS) provides comprehensive regulatory program management support that ensures alignment with and execution of Pfizer Oncology’s regulatory strategies and submission deliverables. This position...Permanent employmentH1bLocal areaVisa sponsorshipWork visaRelocation package2 days per week- ...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
- ...Alnylam Switzerland GmbH in Cambridge, MA is seeking an Associate Director, Regulatory Affairs CMC to lead the development and execution of global regulatory strategies for innovative therapeutics, particularly in CMC Development. This role combines scientific expertise...
$228k - $313.5k
Pioneering Medicines is seeking an Executive Director, CMC to drive portfolio-level CMC strategy and execution. This senior leadership role will oversee CMC across the full portfolio, engage with cross-functional teams, and build a strategic CDMO network. The ideal candidate...$183.55k - $275.32k
...Director/Sr. Director, Regulatory Labeling Strategy, Advertising, and Promotion, Regulatory Who we are: At Agios, we are fueled by connections to transform... ...trends. Ensure timely and accurate FDA 2253 submissions of US promotional materials. Interface with regulatory...Temporary workLocal areaRemote workWork from homeFlexible hours3 days per week$250k - $310k
...Role Summary The Executive Director, Regulatory Affairs serves as a visionary... ...long‑term program regulatory strategy, collaborates on regulatory... ...lifecycle Oversee preparation and submission of major regulatory filings... ...clinical, nonclinical, and CMC development is critical Deep...Local area
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