Director, Regulatory Affairs
Biopharma Careers
Vertex is seeking an Executive Director of Regulatory Strategy to lead global regulatory efforts for its Type 1 Diabetes portfolio. You will guide senior cross-functional teams, shaping strategy and liaising with health authorities while driving program leadership and staff development. The role requires deep regulatory expertise, strategic thinking, and the ability to translate complex requirements into executable plans across global programs and regulatory environments. #J-18808-Ljbffr
$154.4k - $242.55k
...boundaries of what is 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...SuggestedMinimum wageTemporary workLocal areaRemote workWorldwide$170.9k - $231.3k
Overview The Associate Director, Regulatory Affairs CMC Development is responsible for developing and implementating global CMC regulatory strategies for development-stage programs. This role will play a critical part in shaping regulatory strategies for emerging therapeutic...SuggestedFull timeTemporary workWork at officeLocal areaFlexible hours$154.4k - $242.55k
...leads global strategies to maximize global regulatory success towards achievement of program... ....Accountabilities:The Associate Director will be responsible for complex or highly... ...understanding broad concepts within regulatory affairs and implications across the organization...SuggestedMinimum wageTemporary workLocal areaRemote work$170.9k - $231.3k
OverviewThe Associate Director of Regulatory Affairs Strategy will work on assigned programs with the respective Global Regulatory Portfolio Lead, Global Regulatory Lead and cross-functional team to lead and define the regulatory strategy, facilitate submission of data...SuggestedFull timeTemporary workLocal areaWorldwideFlexible hours2 days per week$238k - $374k
...that all 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?...SuggestedMinimum wageTemporary workLocal areaRemote work$238k - $374k
...push the 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...Minimum wageTemporary workWork at officeLocal areaRemote workWorldwide$231.9k - $365k
Job DescriptionOur Regulatory Affairs team in General Medicine advances medical innovation to patients by establishing clear, timely, and robust... ...and professionalism.Position Description:The Executive Director, Regulatory Affairs Liaison reports to the Vice President (VP...Full timeFor contractorsLocal areaWorldwideFlexible hours$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... ...in Chemistry, Biology, Pharmacy, Regulatory Affairs, Pharmaceutical Sciences, Engineering, or...Full timeSummer workRemote workFlexible hours2 days per week$180k - $245k
OverviewMonte Rosa Therapeutics is seeking an experienced and strategic Director of Regulatory Affairs to lead and support global regulatory efforts across our development programs, with a focus on immunology. The ideal candidate will be responsible for developing and...$215k - $235k
...self. At Arbor, our people embrace these qualities, so if this sounds like you then please read on!About the Role: The Director of Regulatory Affairs is responsible for leading regulatory strategy and execution for Abror’s development programs across the portfolio, spanning...- ...Chief Medical OfficerPosition SummaryThis individual will lead regulatory strategy and execution for growing clinical-stage oncology... ...strategically, work independently, and help build Regulatory Affairs capabilities as the clinical pipeline grows.Key ResponsibilitiesDevelop...2 days per week3 days per week
$218.06k - $327.09k
Job Title: Senior Director, Regulatory Affairs Strategy - Cell Therapy Available locations: Gaithersburg, MDBoston, MASouth San Francisco, CASanta Monica, CAIntroduction to role: Are you ready to set the global regulatory vision for pioneering cell therapies and turn breakthrough...Hourly payFull timeTemporary workStart working todayWork at officeFlexible hours3 days per week- ...The Associate Director of Regulatory Affairs CMC will be responsible for developing, implementing and advising on global Regulatory CMC strategies for new and late stage programs to secure approval of the manufacturing process and control testing for initial clinical...
$170.9k - $231.3k
...Overview The Associate Director of Regulatory Affairs Strategy will work on assigned programs with the respective Global Regulatory Portfolio Lead, Global Regulatory Lead and cross-functional team to lead and define the regulatory strategy, facilitate submission...Full timeTemporary workLocal areaWorldwideFlexible hours2 days per week$175.35k - $219.2k
...About the Job: The Associate Director, Regulatory Affairs is responsible for supporting the regulatory function and its activities, the development of regulatory strategy, and contributing the regulatory approval process (including US FDA and other regulatory authorities...- ...Zugo-cel CAR-T franchise at CRISPR. Reporting to the Head of Regulatory Affairs, you will work closely with cross-functional teams and... ...track record of significant accomplishments: ~ Associate Director: ~12+ Years of relevant experience with a bachelor's degree...Contract workRemote work
- ...Alnylam Switzerland GmbH in Cambridge, MA is seeking an Associate Director, Regulatory Affairs CMC to lead the development and execution of global regulatory strategies for innovative therapeutics, particularly in CMC Development. This role combines scientific expertise...
$195k - $330k
...and heard.How you’ll make an impact:Act as the global regulatory strategy lead for Kymera’s IRF5 degrader program, developing... ...required; advanced degree preferred but not required.Director: 8-10 years of Regulatory Affairs experience. Senior Director: 10-12+ years of...Flexible hours$281k - $344k
...patients – realizing a world where people with immune‑mediated diseases can live life fully. Job Summary: The Executive Director, Regulatory Affairs will report to the Senior Vice President, Regulatory Affairs & Quality and serve as the Global Regulatory Lead to provide...For contractorsLocal areaFlexible hours2 days per week$275k - $315k
Position OverviewBicara Therapeutics is seeking a strategic and experienced Senior Director of Regulatory Affairs to lead and execute US regulatory strategy for our biologics pipeline. Reporting to the VP, Regulatory Affairs, you will serve as the primary US regulatory...Full timeTemporary workWork at officeLocal area3 days per week- ...’s research and development is focused on understanding and meeting patient needs using our novel therapies. Tasks The Director of Regulatory Affairs provides strategic and operational leadership to the development and commercialization of products for one or more of the...Work at officeLocal area
- ...Vertex Pharmaceuticals LLC is seeking a Director of Regulatory Affairs CMC in Boston. The role leads a Regulatory CMC team, shaping global strategies for small molecule programs and coordinating Health Authority interactions across development and commercialization. Hybrid...
- ...Bausch Health Companies Inc. is seeking a Senior Director of Advertising & Promotion – Regulatory Affairs to lead and participate in reviews of promotional labeling for prescription, OTC, and cosmetics in the US, with support for Canada. The role ensures materials comply...
- ...S&P Global Energy seeks an Associate Director, Regulatory Research Associates to lead evaluation of state utility regulation and market developments across the U.S. energy sector. You will shape datasets, build analytical frameworks, and deliver high-impact insights to...
$196.7k - $353.4k
...The Role Moderna Therapeutics is seeking a Sr. Director of Regulatory Strategy to support oncology programs to be based in its Cambridge headquarters... ...Sr. Director will be a strategic leader within Regulatory Affairs, responsible for developing and executing regulatory plans...Permanent employmentWork at officeLocal areaWork from home$163.5k - $281.6k
...best to work that truly matters for patients, we invite you to join us. Responsibilities Develop and implement comprehensive global regulatory CMC strategies for assigned gene therapy programs, including IND/CTA, BLA/MAA, and post-approval submissions. Lead and manage the...Full timeFor contractorsWork at officeFlexible hours$210.9k - $316.3k
...through compliant, compelling promotion. The Director, Advertising and Promotion serves as the U.S. promotional regulatory lead for assigned products and is accountable... ...The Director leads and represents Regulatory Affairs on Promotional Review Committees, ensuring that...Work at officeFlexible hours3 days per week- ...investments, we push the boundaries of what is possible in order to bring life‑changing therapies to patients worldwide. The Director, Regulatory Site CMC ensures efficient and compliant management of regulatory change control and post‑approval activities at the site...Local areaWorldwide
- ...Noema Pharma in Massachusetts is seeking a Director of Regulatory Affairs to lead regulatory strategy and execution across clinical programs, reporting to SVP Regulatory Affairs. You will drive IND/NDA submissions, interact with FDA, and build regulatory capabilities...
$163.5k - $281.6k
...matters for patients, we invite you to join us. Eli Lilly and Company is seeking a highly experienced and strategic Director/Senior Director, Regulatory CMC to lead and execute regulatory CMC strategies for our cutting‑edge gene therapy portfolio. This role will be critical...Full timeFor contractorsWork at officeFlexible hours
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