Senior CMC Regulatory Lead — Associate Director
Relay Therapeutics
Relay Therapeutics is recruiting for an Associate Director/Director, CMC Regulatory in Cambridge, MA. You will lead regulatory CMC strategies for small molecule programs, develop global submission plans, and coordinate cross-functional teams to ensure regulatory success. You will manage complex IND/IMPD/NDAs, contribute to regulatory intelligence, and oversee responses to RFIs with minimal supervision, driving high-quality submissions and robust compliance. #J-18808-Ljbffr Relay Therapeutics
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$161.5k - $218.5k
OverviewThe Associate Director, Downstream, Emerging Modalities... ...purification as well as lead program(s) with the... ...transition by leading CMC team as necessary for... ...Formulation Development, Regulatory, Technical Operations,... ...-functional teams and senior leadership.This role...SuggestedFull timeTemporary workLocal areaFlexible hours- 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...SuggestedWork at officeWorldwide
$145 - $170 per hour
...Search Open Jobs View our latest job openings and see how Eastridge can help you find your next opportunity. Senior Regulatory CMC Lead Compensation: $145.00 - $170.00 Loading... Eastridge Workforce Solutions is committed to connecting skilled professionals with...SeniorHourly payFull timeTemporary workLocal areaRemote workMonday to FridayShift work$154.4k - $242.55k
...patients worldwide.This role is within the Global Regulatory Affairs (GRA) Chemistry Manufacturing & Controls (CMC) and Devices organization, and will contribute to... ...follows: With minimal supervision, develops and leads the execution of regulatory CMC investigational,...SuggestedMinimum 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... ...applications, and health authority briefing packages.Lead or help to lead the interpretation of regulatory...Full timeTemporary workWork at officeLocal areaFlexible hours$166.4k - $249.6k
Job DescriptionGeneral Summary:The 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 regulatory CMC submissions and manages...Full timeSummer workRemote workFlexible hours2 days per week$166.4k - $249.6k
...Description General Summary: The 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 regulatory CMC submissions and manages...Summer workRemote workFlexible hours2 days per week- ...Job Description Job Description Primary Responsibilities 1. Global Regulatory CMC Strategy Lead and drive the global Regulatory CMC strategy for biologic ADC programs. Provide strategic guidance for global MAA/BLA preparation and submission activities. Ensure...SeniorWork at officeRemote workFlexible hours
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- ## Associate Director, Regulatory Affairs CMCApplyremote type: Site Basedlocations: South Boston, MAtime... ...decade ago, CRISPR Therapeutics is a leading biopharmaceutical company focused on... ...therapies to patients. As the Regulatory CMC lead for these programs, you will...Contract workRemote work
- ...patients worldwide. This role is within the Global Regulatory Affairs (GRA) Chemistry Manufacturing & Controls (CMC) and Devices organization, and will contribute to... ...follows: With minimal supervision, develops and leads the execution of regulatory CMC investigational,...Worldwide
$237.7k - $356.5k
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...team, 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, accountable for developing and leading the execution of regulatory CMC...$237k
...Vertex Pharmaceuticals seeks a Senior Director to lead Chemistry, Manufacturing, and Controls strategy for Type 1 Diabetes... .... The role involves developing integrated CMC plans across development, scale-up, regulatory submission, and commercialization while partnering...Senior$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$166.4k - $249.6k
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...the role:We are seeking an experienced and visionary Senior Director, Small Molecule CMC Advisor to lead the analytical development strategy for our small... ...on the development of a holistic control strategy.Regulatory Submissions: Author, review, and defend analytical...SeniorMinimum wageLocal areaRemote work$195k - $330k
...focused on building an industry-leading pipeline of oral small... ...make an impact:Drive end-to-end CMC program management for mid to... ...product, analytical, quality, regulatory, and supply chain workstreams... ...years of CMC experience; Sr. Director level requires commensurate additional...Senior$212k - $333.19k
...you to shine? Join us as a Senior Director, Global Program Lead- Neuroscience in our... ...development and LCM projects associated with an asset from... ...to simultaneously driving regulatory approval as well as launch... ...Pharmaceutical Sciences (CMC) Subteam, etc. to the GPT...SeniorMinimum wageWork at officeLocal areaRemote work$154.4k - $242.55k
...Pharmaceutical Sciences and Precision MedicineThe Global Regulatory Labeling Strategy Lead (Associate Director), Plasma-Derived Therapies Business Unit (PDT BU) is... ...and succeedAble to influence without authority at senior level (TET/TET-1, GLOC)Demonstrates agile leadership...Minimum wageLocal area$154.4k - $242.55k
...empower you to shine? Join us as an Associate Director, Global Biomarker Lead, Inflammation, GI2 TAU based in Cambridge, MA reporting to the Senior Director, Head Inflammation Biomarkers... ...and documents submitted to Regulatory Agencies.• Establish and maintain scientific...Minimum wageLocal area- ...StatesCompany: Sarepta TherapeuticsPosted: 2026-10-23Sarepta Therapeutics is seeking an Associate Director, Medical Writing to independently plan, develop, and deliver high-quality clinical and regulatory documents for our pipeline in Duchenne and beyond. This fully remote US-...Remote work
$167k - $286k
...Company: Wave Life SciencesPosted: 2026-10-25Associate Director/Director, Platform and Pipeline Medical Affairs Lead Cambridge, MA, United States Job Description Wave... ...the burden of disease. Description: The Director/Associate Director, Platform and Pipeline Medical Affairs...Full timeContract workTemporary workSummer workWork at officeLocal area$161.6k - $242.4k
Job DescriptionGeneral Summary:The Regulatory Labeling Associate Director will be responsible for strategic labeling and for... ...and associated business processes.Leads label working groups and representing labeling at senior labeling governance meetings.Develops and...Full timeSummer workWork at officeRemote workFlexible hours2 days per week- Moderna seeks a Senior Manager, GRS Integration in Cambridge, MA to lead regulatory planning and execution for multiple programs. You will partner with GRLs, Country Regulatory Leads, and CMC teams to translate strategy into integrated plans, manage risks, and ensure timely...Senior
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$161.6k - $242.4k
## Regulatory Labeling Associate DirectorApply: Boston, MA: Full time: Posted Today: REQ... ...Labeling Associate Director will be responsible for strategic... ...associated business processes.* Leads label working groups and representing labeling at senior labeling governance meetings...Full timeSummer workWork at officeRemote workFlexible hours2 days per week$204k - $281k
About This Role:As the CMC Asset Lead, you will be an integral part of the PO&T Nephrology team, focusing on the development and launch of Biogen's nephrology assets. Your initial focus will be on overseeing a critical asset in clinical development for multiple indications...Full timeTemporary workLocal area
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