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- ...CRISPR Therapeutics, based in Boston, is seeking an Associate Director for Regulatory Affairs CMC to oversee regulatory strategies for innovative gene therapies. This leadership role requires extensive experience in CMC regulatory requirements for biologics and gene therapies...RegulatoryRemote workFlexible hours
$147.5k - $221.3k
Job DescriptionGeneral Summary:The Associate Director, CMC Quality Compliance and Inspection Readiness, is responsible for inspection... ...and governance forumsKnowledge and Skills:Knowledge of regulatory requirements and inspection expectations globallyExperience in...RegulatoryFull timeSummer workRemote workFlexible hours2 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...RegulatoryFull timeSummer workRemote workFlexible hours2 days per week$224k - $336k
Position: Executive Director, Process Development & CMC Lead Location: Danbury, CTJob Id: 11298... ...-phase development experience, including Phase 3 execution, regulatory submissions, process validation, PPQ strategy, and commercial launch...RegulatoryRemote workMonday to FridayShift work$184.6k - $277k
Job DescriptionGeneral Summary:The CMC Quality Compliance Director is responsible for inspection readiness and compliance of internal... ...manufacturing/testing sites. Monitor and interpret cGMP regulatory guidelines and trends in the regulatory space and incorporate into...RegulatoryFull timeWork experience placementSummer workRemote workFlexible hours2 days per week$190.4k - $285.6k
Job DescriptionGeneral Summary:The Director, Chemistry Manufacturing Controls (CMC) leads a Regulatory CMC team responsible for developing and executing global regulatory strategies across multiple investigational and commercial products in the small molecule portfolio....RegulatoryFull timeSummer workRemote workFlexible hours2 days per week$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 on complexity, through all stages of a products lifecycle. The Associate Director will be responsible for developing...RegulatoryPermanent employmentFull timeWork at officeWork from home- Piper Companies is seeking a Senior Director, Quality & CMC Regulatory Strategy to guide regulatory strategy from development through lifecycle management for biotechnology and pharmaceutical clients. The role focuses on leading global CMC activities, client liaison, and...RegulatoryRemote job
$132k - $172k
...paths as we move toward a common goal of elevating science and service for rare patients.Position Summary:The Senior Manager, CMC Regulatory Affairs is responsible for providing strategic and operational regulatory leadership for Chemistry, Manufacturing, and Controls...RegulatoryFull timeTemporary workRemote work$132k - $172k
...paths as we move toward a common goal of elevating science and service for rare patients.Position Summary:The Senior Manager, CMC Regulatory Affairs is responsible for providing strategic and operational regulatory leadership for Chemistry, Manufacturing, and Controls...RegulatoryFull timeTemporary workRemote workWorldwide- ...patient advocacy and care. Discover more here.Who we are looking forThis is what you will doCurrently seeking a Regulatory Affairs (RA) Manager with strong CMC pre and post approval experience to support Chiesi’s Global Rare Diseases (GRD) global portfolio of commercial...RegulatoryHourly payWork at officeLocal areaRemote workRelocation packageFlexible hours
$193.1k - $289.7k
Job DescriptionGeneral Summary:The CMC Statistics Director (Scientific Fellow) provides strategic and technical leadership for the... ...continued process verification (CPV), stability, quality control, and regulatory submissions. This individual will establish and lead the CMC...RegulatoryFull timeSummer workRemote workFlexible hours2 days per week$246.98k - $299.29k
...personal lives. Read more: careers.bms.com/working-with-us.The GRS-CMC Director is responsible for overseeing management of multiple... .... Develop and communicate strategic direction based on global regulatory guidelines and experience. Seeks opportunities for external...RegulatoryHourly payFull timeTemporary workPart timeFor contractorsSummer workLive inWork at officeLocal areaRemote workFlexible hoursShift work$148.5k - $257.4k
...people who are determined to make life better for people around the world.This role provides strategic, tactical and operational regulatory CMC leadership across therapeutic modalities and manufacturing technologies to expedite development of the small molecule portfolio...RegulatoryRemote workRelocation packageFlexible hours$177k - $278.08k
...possible in order to bring life-changing therapies to patients worldwide.This role is within the Global Regulatory Affairs (GRA) Chemistry Manufacturing & Controls (CMC) and Devices organization, and will contribute to the team’s delivery of critical functions as follows...RegulatoryMinimum wageTemporary workLocal areaRemote workWorldwide$150k - $195k
...Summary:The Associate Director, Technical Operations (Small Molecule CMC) will provide technical oversight for small molecule API... ...drug products.This individual will partner closely with Quality, Regulatory Affairs, Clinical, and Supply Chain to ensure alignment, risk...RegulatoryFull timeContract workTemporary workRemote work$238k - $374k
...boundaries of what is possible in order to bring life-changing therapies to patients worldwide.As Executive Director, Global Regulatory Affairs CMC Devices and Drug-Device Combination Product, you will provide strategic leadership and development to global regulatory...RegulatoryMinimum wageTemporary workWork at officeLocal areaRemote workWorldwide$238k - $374k
...information I submit in my employment application is true to the best of my knowledge.Job DescriptionExecutive Director, Global Regulatory Affairs CMC Early DevelopmentAre you looking for a patient-focused company that will inspire you and support your career? Join us as...RegulatoryMinimum wageTemporary workLocal areaRemote work$224.9k - $404.6k
...position will be based at Norwood MA site and will be responsible for managing a team of CMC experts that prepare and oversee CMC and Quality related agency correspondence and regulatory applications. This position will be required to oversee the product strategy for all...RegulatoryPermanent employmentFull timeWork at officeWork from home$167k - $300.7k
...Digital Operations and Strategic Portfolio Management, the Director, CMC Digital Operations and Strategic Portfolio Management will own... ...in accordance with U.S. law. Due to the nature of the work and regulatory requirements, only individuals who qualify as U.S. persons (...RegulatoryPermanent employmentFull timeWork at officeWork from homeShift work- ...through rigorous science and a collaborative, mission-driven culture. Primary Responsibilities The Director/Senior Director, Regulatory CMC (Chemistry, Manufacturing, and Controls) is a pivotal regulatory role responsible for developing and executing regulatory...RegulatoryRemote workFlexible hours
IMMUNEERING CORPORATION
Cambridge, MA12 days ago $121.6k - $194.5k
...and delivery of data products and AI use cases across Moderna's CMC organization. This role operates at the intersection of... ...in accordance with U.S. law. Due to the nature of the work and regulatory requirements, only individuals who qualify as U.S. persons (citizens...RegulatoryPermanent employmentFull timeWork at officeWork from home- ## Associate Director, Regulatory Affairs CMCApplyremote type: Site Basedlocations: South Boston, MAtime type: Full timeposted on: Posted... ...bring multiple novel therapies to patients. As the Regulatory CMC lead for these programs, you will have the opportunity to devise...RegulatoryContract workRemote work
$189.7k - $237.1k
...shybrid modelrequires this role to work in our office three days per week on average . Position Summary Join Acadia as the Director, Regulatory CMC and play a critical role in advancing innovative small molecule therapies from development through commercialization worldwide....RegulatoryWork at officeLocal areaRemote workWorldwideNight shift3 days per week$189.7k - $237.1k
...hybrid model requires this role to work in our office three days per week on average Position Summary Join Acadia as the Director, Regulatory CMC and play a critical role in advancing innovative small molecule therapies from development through commercialization worldwide....RegulatoryWork at officeLocal areaRemote workWorldwideNight shift3 days per week- PATH seeks a Global Head of Chemistry, Manufacturing and Controls (CMC) and Non-clinical Toxicology to lead CMC/NT activities across a program portfolio, ensuring on-time, on-budget delivery and regulatory readiness. The role drives process development, analytics,...RegulatoryRemote job
$207k - $253k
## Director, Regulatory Affairs CMCApplylocations: MA - Waltham - Officetime type: Full timeposted on: Posted 3 Days Agojob requisition id... ...role provides strategic, tactical and operational regulatory CMC leadership to support clinical trial applications, market registrations...RegulatoryMinimum wageFull timeLocal areaFlexible hours- ...engagements. This client-facing consulting role serves as the operational lead for CMC programs, coordinating cross-functional activities across manufacturing, analytical, quality, regulatory, and supply chain functions from early development through commercialization....RegulatoryFull timeContract workWork at office
Syner-G BioPharma Group
Remote17 days ago - Astellas is seeking a CMC leader to drive asset strategy and execution across development, manufacturing, regulatory and lifecycle management. This role requires coordinating with multiple functions to maximize VALUE and ensure launch readiness. Based in Northbrook, IL...RegulatoryRemote work
- ...and YouTube. Job Description The Senior Associate, RA CMC is responsible for ensuring RA-CMC post approval change objectives... ...all key partners in the functional departments in support of regulatory filings. Responsibilities: Manage, compile, and author...RegulatoryFull timeTemporary workWork at officeLocal areaRemote work
AbbVie Inc.
North Chicago, ILa month ago
