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 Anagram Therapeutics, Inc.
- Associate Director - Regulatory Affairs CMC Location: Natick, MA About the role: This role provides strategic, tactical... ...regulatory CMC submission strategies, and conducting regulatory CMC intelligence... ...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$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...SuggestedSummer 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
$166.4k - $249.6k
...Vertex Pharmaceuticals seeks an Associate Director in CMC Regulatory Affairs to lead global regulatory strategies for investigational and marketed products. The role involves preparing and filing regulatory submissions, managing health authority interactions, and providing...- 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...
- 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
$180k - $205k
...patient needs. The Company has a proven strategy of advancing clinically validated... ...are seeking a strategic, hands-on Associate Director, Regulatory Affairs to lead regulatory project teams and... ...teams across clinical, nonclinical, CMC, and commercial functions. Serve as...Work at office$154k - $215k
...positive Phase 3 results for our lead candidate, it’s an... ...more: Position Summary The Associate Director, Regulatory Affairs will serve as a regulatory... ...and executing regulatory strategies that enable efficient multinational... ...Partner with Clinical, CMC, Quality, Research, and...Local areaRemote workVisa sponsorshipWork visa$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$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- ...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
- 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
$200k - $221k
...Associate Director, Regulatory Affairs, AD Promo United States - Remote Location: This position may be... ...& Promotion will be the regulatory lead for advertising and promotional activities... ...Medical Affairs, Legal, Regulatory Strategy, and Regulatory Operations to build...Work at officeLocal areaRemote work$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$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$175.35k - $219.2k
About the Job: The Associate Director, Regulatory Affairs is responsible for supporting the regulatory function... ..., the development of regulatory strategy, and contributing the regulatory approval... ...incumbent will be responsible for leading a team of 3-5 employees. This...- ...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
$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...$258.83k - $293.48k
...for metabolic dysfunction-associated steatohepatitis (MASH), a... ...by our shared purpose: leading the fight against MASH.... ...strengthening our workforce strategy to ensure we have the right... ...right way. The Senior Director of Regulatory Affairs CMC provides highly strategic...Minimum wageFull timeWork at officeLocal areaFlexible hours3 days per week$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- 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 multiple...Work at office
$186.23k - $279.35k
...Seaport, Boston Reports to: Senior Director, Global Regulatory Strategy About Alexion For over 30... ...people living with rare diseases. We lead with breakthrough science, deep disease... ...: The Director, Regulatory Affairs US lead will be accountable for the...Temporary workWork at office$147.5k - $221.3k
Job DescriptionGeneral Summary:The Associate Director, CMC Quality Compliance and Inspection Readiness... ...and Skills:Knowledge of regulatory requirements and inspection expectations... ...as six sigma or leanProven ability to lead improvement projects and project teams...Full timeSummer workRemote workFlexible hours2 days per week$122.25k - $176.58k
Job Title: CMC Demand & Supply LeaderLocation: Framingham... ...to integrate Project Strategy, Clinical and CMC... ...Projects in respect to Regulatory and Quality requirements... ...alignment scenario with associated risks and costs to... ...and budget definition.Co-lead Demand & Supply Sub Team...Full time$142.5k - $256.5k
The RoleThe Global Regulatory CMC Lead will be responsible for coordinating regulatory CMC activities for one or more products, depending... ...Lead will be responsible for developing global regulatory CMC strategies and collaborating with key stakeholders to execute the...Permanent employmentFull timeWork at officeWork from home$200k - $265k
...ambition to become the leading dermatology company... ...OpportunityLeads the global regulatory strategy, submission planning,... ...Global Regulatory Affairs team supporting... ...FDAIdentify and assess risks associated with product... ...clinical, non-clinical, and CMC development...Full timeTemporary workWork experience placementWork at officeWorldwide$242k - $313.5k
...Senior Director, Regulatory Affairs CMC – Small Molecule Cambridge, Massachusetts... ...and delivering category-leading precision therapies to transform... ...executing CMC regulatory strategies from early clinical... ...-site comparability, and associated regulatory filing updates...Contract workFor contractorsWork at officeLocal area2 days per week$145 - $170 per hour
...find your next opportunity. Senior Regulatory CMC Lead Compensation: $145.00 - $170.00 Loading... ...our client’s global Regulatory Affairs team. Created/Revised Date : September... ...focus on Module 3, global regulatory strategy, and FDA/EMA interactions. Local Boston...Hourly payFull timeTemporary workLocal areaRemote workMonday to FridayShift work
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