Associate Director, Regulatory Affairs CMC Strategy Lead
Anagram Therapeutics, Inc.
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-functional teams to ensure compliant, timely filings while navigating evolving regulatory requirements.
Lead regulatory strategy, guide teams through Module 3, and drive inspections readiness in a fast-paced biotech setting.
#J-18808-Ljbffr- ...strategic, tactical and operational regulatory CMC leadership to support... ...regulatory CMC submission strategies, and conducting regulatory CMC... .... Responsibilities: The Associate Director, Regulatory Affairs CMC will be responsible for leading regulatory CMC activities for...Suggested
$154.4k - $242.55k
...This role is within the Global Regulatory Affairs (GRA) Chemistry Manufacturing & Controls (CMC) and Devices organization, and... ...minimal supervision, develops and leads the execution of regulatory CMC... ...and/or post-approval strategies for assigned products. RA CMC member...SuggestedMinimum wageLocal areaRemote workWorldwide$166.4k - $249.6k
...Chemistry Manufacturing Controls Associate Director executes multi-product global regulatory CMC strategies for investigational and marketed products. This role leads the preparation and filing of... ...Chemistry, Pharmacy, Regulatory Affairs for Drugs, Biologics or Medical...SuggestedFull timeSummer workRemote workFlexible hours2 days per week- ## Associate Director, Regulatory Affairs CMCApplyremote type: Site Basedlocations: South Boston... ...CRISPR Therapeutics is a leading biopharmaceutical company... .... As the Regulatory CMC lead for these programs, you... ...implement innovative Regulatory strategies where little precedent...SuggestedContract workRemote work
- Anagram Therapeutics, Inc. in Natick, MA is seeking an Associate Director to lead regulatory CMC activities across a broad portfolio for clinical and commercial programs. You will plan submission strategies, coordinate cross-functional teams, and ensure submissions meet...Suggested
$180k - $205k
...Associate Director, Regulatory Affairs Seaport Therapeutics is a clinical-stage therapeutics... ...The Company has a proven strategy of advancing clinically... ...Director, Regulatory Affairs to lead regulatory project teams... ...clinical, nonclinical, CMC, and commercial functions....Work at office- Moderna is seeking an Associate Director, Global Regulatory Affairs, CMC, to lead and oversee regulatory activities for CMC and Quality, coordinating worldwide submissions and agency communications. The role requires 10+ years in pharma/biotech with strong EU/ROW regulatory...Work at officeWorldwide
$230k - $250k
...Director, Global Regulatory Affairs - Strategy Lead Olema Oncology is a clinical-stage biopharmaceutical company committed to transforming the standard of care and improving outcomes for patients living with breast cancer and beyond. With our transformation into a fully...Work at officeFlexible hours2 days per week$207k - $253k
...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...Full time- ...DetailExperience Level Associate DirectorDegree Type Bachelor... ...Points Lead impactful regulatory projects ensuring compliance... ...Job DescriptionAssociate Director of Regulatory Affairs OverviewThe Associate Director... ...employees and agents.Shape strategies based on emerging trends...Work at office
$154.4k - $242.55k
...for the delivery of global regulatory strategies to support development and... ...Responsible for developing and leading the global regulatory... ...represent the Global Regulatory Affairs (GRA) function in senior... ...comments and supporting trade association working groups.Education &...Minimum wageLocal areaRemote work- Celldex Therapeutics, Inc. is seeking a Senior Director, Regulatory Science and CMC Development Strategy to lead early-stage CMC regulatory strategy and provide regulatory... ...This senior leader reports to the VP, Regulatory Affairs and partners with Manufacturing and Quality to...
- Repertoire Immune Medicines is seeking an experienced Director of Regulatory Affairs to lead global regulatory strategy for Phase 1/2 oncology programs, based in... ...guidance while partnering with Clinical Development, CMC, and Quality to advance innovative therapies for patients...Work at office3 days per week
$142.5k - $256.5k
The RoleModerna is looking for an Associate Director, Global Regulatory Affairs, CMC, to join our team. This pivotal... ...products. The successful candidate will lead and support all regulatory... ...implementing effective CMC regulatory strategies for international submissions (e....Permanent employmentFull timeWork at officeWork from home$166.4k - $249.6k
...Summary:The Chemistry Manufacturing Controls (CMC) Associate Director leads and executes global regulatory CMC strategies across investigational and commercial products... ...degree in Biology, Chemistry, Pharmacy, Regulatory Affairs, or related life science field (advanced...Full timeSummer workRemote workFlexible hours2 days per week$175.35k - $219.2k
...About the Job: The Associate Director, Regulatory Affairs is responsible for supporting the regulatory... ...activities, the development of regulatory strategy, and contributing the regulatory... ...incumbent will be responsible for leading a team of 3-5 employees. This...$153.6k - $241.34k
...Associate Director, Global Regulatory Affairs – GI & Inflammation Apply for the role at TakedaPharmaceutical Nordics... ...strategic and tactical advice, leads cross‑functional initiatives, and... ...Accountabilities Lead global regulatory strategies for complex or highly complex...Full timeTemporary workRemote work$190k - $210k
...Associate Director, Global Regulatory Affairs, Compliance Responsibilities Translate applicable laws, regulations, and guidance into practical regulatory compliance strategies supporting development and business objectives. Support high-quality, timely execution of regulatory...Flexible hours$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 strategy and for providing... ...partners closely with the Regulatory CMC lead, Manufacturing, and Quality to strengthen...- ...Job Description Job Description Associate Director, Regulatory Affairs Location: Boston, MA (Hybrid or East... ...and pragmatic regulatory strategy. Role Overview We are seeking... ...across multidisciplinary teams including CMC, clinical, and nonclinical functions...Permanent employmentFull time
$142.5k - $256.5k
The Role Moderna is looking for an Associate Director, Global Regulatory Affairs, CMC, to join our team. This pivotal... ...products. The successful candidate will lead and support all regulatory... ...implementing effective CMC regulatory strategies for international submissions (e....Permanent employmentWork at officeLocal areaWork from home$180k - $245k
...seeking an experienced and strategic Director of Regulatory Affairs to lead and support global regulatory... ...developing and executing regulatory strategies that support global product development... ...immunology background is preferred. CMC experience is a plus.ResponsibilitiesDevelop...$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... ...Biology, Pharmacy, Regulatory Affairs, Pharmaceutical Sciences, Engineering...Full timeSummer workRemote workFlexible hours2 days per week$242k - $313.5k
...Senior Director, Regulatory Affairs CMC – Small Molecule About Beeline Medicines... ...and delivering category-leading precision therapies to transform... ...executing CMC regulatory strategies from early clinical... ...‑site comparability, and associated regulatory filing updates...Local area2 days per week$207k - $253k
## Director, Regulatory Affairs CMCApplylocations: MA - Waltham - Officetime... ...dysfunction-associated steatohepatitis (MASH... ...our shared purpose: leading the fight against MASH... ...our workforce strategy to ensure we have the... ...operational regulatory CMC leadership to support...Minimum wageFull timeLocal areaFlexible hours- ...applications for Advisor/Sr. Advisor - Global Regulatory Affairs (GRA) – CMC Platform Regulatory Scientist. This role provides global regulatory strategies and technical CMC support across... ...global CMC regulatory strategies, leading preparation of CMC submissions, guiding...
- ...Moderna Therapeutics is seeking an Associate Director of Global Regulatory Affairs, CMC, to oversee CMC and Quality agency correspondence and regulatory applications for global products. You will lead regulatory activities, ensure high-quality CMC sections, and manage...Work at office
- ...Centessa Pharmaceuticals is seeking a Senior Director, Regulatory CMC in the US to provide strategic and operational leadership for Regulatory CMC activities across small molecule programs. You will drive regulatory readiness, oversee submissions, and manage external...
$154.4k - $242.55k
...patients worldwide.Join Takeda as Associate Director, Global Regulatory Lead Oncology where you will be part of... ...define and lead global regulatory strategies for oncology programs, oversee major... ...broad concepts within regulatory affairs and implications across the...Minimum wageLocal areaRemote workWorldwide$136.51k - $204.77k
...Job Title: Associate Director, CMC Lead Introduction to role: Are you ready to lead early-stage CMC strategy that turns precision radioconjugate science into first-in-human... ...readiness. IND/IMPD Readiness: Lead CMC regulatory strategy; guide and contribute to...Hourly payTemporary work
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