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
$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$163k - $225k
...Operations and Technology (PO&T) Division is looking to hire a CMC Asset Lead. This Associate Director level Asset Lead is a member of the Asset Development... ..., quality, supply chain, device (if applicable) and regulatory CMC, in the development of and delivery on the PO&T...SuggestedFull timeTemporary workLocal area$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...SuggestedFull timeTemporary workWork at officeLocal areaFlexible hours$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- ## 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...SuggestedContract workRemote work
$136.51k - $204.77k
...Associate Director leading chemistry, manufacturing, and controls strategy for early-stage alpha-emitting radioconjugate programs. Will develop... ...-IND portfolio to drive first-in-human readiness Lead CMC regulatory strategy and author IND/IMPD documentation and data...$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... ...-in-human readiness. IND/IMPD Readiness: Lead CMC regulatory strategy; guide and contribute to authoring high-quality...Hourly payTemporary work$163k - $225k
...Biogen seeks an Associate Director CMC Asset Lead to oversee end-to-end chemistry, manufacturing, and controls strategy for clinical immunology programs... ...across process development, manufacturing, quality, and regulatory functions Serve as PO&T representative on R&D Program...$237.7k - $356.5k
Job DescriptionGeneral Summary:The Senior Director, CMC Product Leader (T1D) will lead the Chemistry, Manufacturing, and Controls (CMC) functional team supporting... ..., scale-up, technology transfer, validation, regulatory submission, and commercialization readiness.As the...SeniorFull timeSummer 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
$143k - $233k
...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...$172.2k - $233k
...Alnylam is seeking an experienced leader to serve as Associate Director, CMC Technology Delivery to lead the digital enablement and transformation of end-to... ...from declaration of Development Candidate (DC) to regulatory filings for Investigational New Drug (IND) and New...Full timeContract workTemporary workLocal areaFlexible hours3 days per week$166.4k - $249.6k
Job DescriptionGeneral Summary:The Chemistry Manufacturing Controls (CMC) Associate Director leads and executes global regulatory CMC strategies across investigational and commercial products focusing on biologics. This role is accountable for authoring, reviewing, and...Full timeSummer workRemote workFlexible hours2 days per week$145k - $240k
...immunological diseases, Kymera is focused on building an industry-leading pipeline of oral small molecule degraders to provide a new... ...areas such as Clinical, Translational Medicine, Research, and/or CMC.Demonstrated ability to partner effectively with internal stakeholders...SeniorContract work$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$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$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- ...If so, this may be the role for you.We currently have an exciting opportunity for a highly motivated Associate Director to join our team of translational medicine leads supporting our exciting internal ADC programs.The Translational Medicine function exists within AstraZeneca...Hourly payFull timeTemporary workWorldwide
$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$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$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$169.4k - $266.2k
...Medical Affairs Oncology team, you will report to the Director, Global Scientific Communications Group Lead. This is a hybrid role based in Cambridge, MA.As a... ..., including ideas for sub-analysesCompliance and Regulatory: Excellent understanding of regulatory, compliance...Minimum wageFor contractorsFreelanceLocal areaRemote work$154.4k - $242.55k
...to accelerate access to transformative medicines and make a lasting impact on patients worldwide.Join Takeda as Associate Director, Global Regulatory Lead Oncology where you will be part of the global regulatory team. As Associate Director, Global Regulatory Lead Oncology...Minimum wageLocal areaRemote workWorldwide$155k - $225k
...company committed to establishing the leading, fully integrated platform for... ...Position Overview:Beam is seeking a Senior Manager/Associate Director, Biostatistics to support the statistical... ...of clinical study reports, regulatory documents, publications, manuscripts...SeniorFull time- ...Inc. in Boston is seeking an experienced Associate Director of Medical Writing to independently author and oversee clinical, regulatory, medical, and safety documents across the... ...scientific judgment and regulatory writing expertise, plus the ability to lead#J-18808-Ljbffr
$154.4k - $242.55k
...empowered to deliver your best. The US Oncology Market Access Analytics Lead will leverage data across multiple sources to create analyses,... ...insights and recommendations to Market Access field teams and senior leadership for decision making and strategy developmentProvide...Minimum wageLocal areaRemote work- ...as we are, join our team.KPMG is currently seeking an Associate Managing Director, KDN Solution Lead - AI to join our KPMG Delivery Network organization.... ...responsible AI practices, ethics, bias mitigation, and regulatory complianceExtensive experience in executive...H1bLocal area
$142.5k - $256.5k
The RoleModerna is looking for an Associate Director, Global Regulatory Affairs, CMC, to join our team. This pivotal role will focus on preparing and overseeing... ...of global products. The successful candidate will lead and support all regulatory activities, ensuring the delivery...Permanent employmentFull timeWork at officeWork from home$142.5k - $256.5k
The Role:The Associate Director, Global Regulatory-CMC will be responsible for coordinating regulatory CMC activities for one or more products, depending... ...our founding in 2010, we have aspired to build the leading mRNA technology platform, the infrastructure to reimagine...Permanent employmentFull timeWork at officeWork from home
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