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- ...Centessa Pharmaceuticals is seeking a Senior Director, Regulatory CMC in the US to provide strategic and operational leadership for Regulatory... ...programs. You will drive regulatory readiness, oversee submissions, and manage external partners to enable timely registrations...Suggested
- ...Anagram Therapeutics, Inc. in Natick, MA is seeking an experienced Associate Director to lead Regulatory Affairs CMC across development and lifecycle stages. You will plan submission strategies, prepare CMC documents for INDs/NDAs/BLAs, and collaborate with cross-...Suggested
$203.16k - $263.84k
Overview The Senior Director, Regulatory Science and CMC Development Strategy is a senior Regulatory Affairs leader responsible for early-stage CMC regulatory... ...responses, and other development-stage regulatory submissions. Manufacturing, Quality, and Site Readiness Partner...Suggested$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$195k - $330k
...make an impact:Lead the development and execution of global regulatory CMC strategies for degrader programs across all stages of development,... ...timelines.Author, review, and approve CMC content for regulatory submissions, including INDs/CTAs, briefing documents, NDA/MAA modules,...Suggested$258.83k - $293.48k
...we are strengthening our workforce strategy to ensure we have the right talent,... ...time, in the right way. The Senior Director of Regulatory Affairs CMC provides highly strategic, tactical... ...registrations and post-approval submissions, along with managing the day-to-day...Minimum wageFull timeWork at officeLocal areaFlexible hours3 days per week- Celldex Therapeutics, Inc. is seeking a Senior Director, Regulatory Science and CMC Development Strategy to lead early-stage CMC regulatory strategy and provide regulatory science across the Celldex portfolio. This senior leader reports to the VP, Regulatory Affairs and...
$155k - $190k
...What You’ll Do: The Associate Director/Director, Program Management... ...teams, including clinical, regulatory, non‑clinical, and technical... ...and lead the execution of submission strategies in alignment with corporate... ...Regulatory, Clinical, Quality, CMC, Medical Writing) Oversee...Full timeLocal areaFlexible hours3 days per week$154.4k - $242.55k
...This role is within the Global Regulatory Affairs (GRA) Chemistry Manufacturing & Controls (CMC) and Devices organization, and... ...and/or post-approval strategies for assigned products. RA CMC... ...development of robust and accurate submissions.Develops constructive relationships...Minimum wageLocal areaRemote workWorldwide$170.9k - $231.3k
OverviewThe Associate Director, Regulatory Affairs CMC Development is responsible for developing and implementing global CMC regulatory strategies for development-stage programs. This role will... .... Experience with regulatory submissions and health authority interactions...Full timeTemporary workWork at officeLocal areaFlexible hours$180k - $245k
...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...$190.4k - $285.6k
...DescriptionGeneral Summary:The Director, Chemistry Manufacturing Controls (CMC) leads a Regulatory CMC team responsible for... ...and executing global regulatory strategies across multiple investigational... ...making, document preparation, and submission execution.Key Duties and...Full timeSummer workRemote workFlexible hours2 days per week- Noema Pharma AG in the Boston area is seeking a Director of Regulatory Affairs to provide strategic and operational leadership across... ...commercialization programs. You will shape regulatory strategy and lead submissions for INDs, NDAs, MAAs and related supplements while...
- ...This role is within the Global Regulatory Affairs (GRA) Chemistry Manufacturing & Controls (CMC) and Devices organization, and... ...and/or post-approval strategies for assigned products. RA CMC... ...development of robust and accurate submissions. Develops constructive relationships...Worldwide
$196.7k - $353.4k
...Role:Moderna, Inc. is seeking a Sr. Director of Regulatory Strategy to lead Regulatory Strategy programs... ...format and accountability for regulatory submissions and related supplements and... ...technical data in partnership with RA CMC and verifies accuracy of clinical data...Permanent employmentFull timeWork at officeWork from home- ...Takeda's Global Regulatory Affairs - CMC team in Cambridge, MA is seeking a Regulatory CMC professional to lead regulatory submissions for investigational, registration and post-approval programs... ...CMC content, develop regulatory strategies, collaborate with cross-functional...
$143k - $233k
...this position will play a key role in regulatory strategy development and execution of assigned Chemistry, Manufacturing and Control (CMC) programs. Your Role: With minimal supervision... ....Develop and execute CMC global submission plans and timelines in accordance with...- ...CMC Regulatory Affairs ManagerThis position is responsible for preparation of CMC submissions for Biologics products. This position will also assist the Regulatory CMC team with... ...Responsible for implementing regulatory strategies, including filing of all appropriate regulatory...
$210k - $320k
...wide range of therapeutic editing strategies that Beam is using to advance a... ...diseases.Position Overview: The Regulatory Director/Sr. Director Regulatory CMC will be responsible for preparing... ...applications, as well as govern CMC submissions and regulatory compliance support...Full timeShift work3 days per week1 day per week- ## Associate Director, Regulatory Affairs CMCApplyremote type: Site Basedlocations... .... As the Regulatory CMC lead for these programs, you... ...innovative Regulatory strategies where little precedent exists... ...knowledge of eCTD requirements for submission to US and ex-US regulatory...Contract workRemote work
- ..., tactical and operational regulatory CMC leadership to support clinical... ...and post-approval submissions, along with managing the daily... ...regulatory CMC submission strategies, and conducting regulatory... ...Responsibilities: The Associate Director, Regulatory Affairs CMC will...
- ...Therapeutics, based in Waltham, MA, seeks a Senior Director, Biostatistics to provide strategic,... ...statistical activities from protocol development to regulatory submissions, ensuring scientifically rigorous, innovative strategies aligned with corporate goals. Ideal...
$228k - $313.5k
...We are seeking an Executive Director, CMC (Chemistry, Manufacturing &... ...driving portfolio-level CMC strategy and execution across multiple... ...Development, Product Development and Regulatory CMC. Accountability for all... ...other than candidates. The submission of unsolicited resumes by...Contract work$242k - $313.5k
...Senior Director, Regulatory Affairs CMC – Small Molecule About Beeline Medicines: Beeline Medicines... ...and executing CMC regulatory strategies from early clinical development through... ...CMC sections of global regulatory submissions in ICH CTD format, including INDs,...Local area2 days per week$182k - $275k
...high-quality, science-based, and compliant regulatory CMC deliverables for assigned program(s), in alignment with strategies established by Global Regulatory Affairs and... ...finalize high-quality CMC regulatory documents and submissions, including core dossiers, INDs, IMPDs, MAAs,...Work at office- ...Reporting to : VP, Regulatory Affairs & Quality About... .... The role As Director, Regulatory Affairs,... ...deliver global regulatory strategy for Hemab's... ...high-quality regulatory submissions and approvals, working... ...scientific, clinical and CMC data into clear regulatory...Remote work
- ...are seeking an experienced Regulatory Affairs CMC leader to provide... ...executing global CMC regulatory strategies that support clinical development... ...be hired at either the Director or Senior Director level.... ...and support for global submissions, including clinical trial...
$175k - $260k
...6. Description Of Role As the Senior Director, Regulatory CMC, you will provide strategic and operational... ...and execute global CMC regulatory strategies, partner with internal and external... ..., and oversee CMC regulatory submissions across our portfolio. The ideal candidate...Full time$230k - $260k
...alternative application process. Director, Regulatory CMC .25 Charlestown-HQ, Charlestown, MA... ...organizations and provides leadership on CMC submission content and regulatory compliance. At... ...and executing global Regulatory CMC strategies for the AAV gene therapy portfolio...Temporary workFlexible hours- Takeda in Boston, MA is seeking a Director Regulatory Site CMC to lead site-specific post-approval change management and regulatory submissions across small molecule and biologics. This... ...ability to communicate regulatory strategy to cross-functional teams. The position...
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