Director, Regulatory Affairs
Kinsley Power Systems
Agios Pharmaceuticals seeks a Director/Sr. Director for Regulatory Labeling Strategy to provide strategic regulatory guidance. You will oversee labeling activities and ensure compliance with FDA regulations. This role involves collaboration with Legal, Commercial, and Medical teams, as well as reviewing promotional materials. The ideal candidate possesses significant experience in regulatory affairs and will contribute to innovative medicine development. Offers hybrid remote work options and a competitive benefits package. #J-18808-Ljbffr
$170.9k - $231.3k
OverviewThe Associate Director of Regulatory Affairs Strategy will serve as US Regional Lead or Global Regulatory Lead for our early/mid/late-stage CNS programs. The role will lead the regulatory strategy and facilitate submission of data packages to the US. The role is...SuggestedFull timeTemporary workLocal areaFlexible hours2 days per week$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
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
...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$276k - $414k
Job Title: Executive 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 direction for first-in-class cell therapies...SuggestedHourly payFull timeTemporary workWork at officeWorldwideFlexible hours3 days per week$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$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?...Minimum wageTemporary workLocal areaRemote work$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$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...$168k - $252k
...Job Description General Summary The Regulatory Strategy Associate Director will be responsible for overseeing the development of regional or global... ...This role requires advanced understanding of regulatory affairs frameworks in the US, Europe, or other international markets...Summer workRemote workFlexible hours2 days per week$142.5k - $256.5k
...The Role The Associate Director, Global Regulatory Advertising and Promotion will be responsible for ensuring compliance with regulatory requirements... ...This role will serve as a key liaison between Regulatory Affairs, Legal, Medical, and Commercial teams to provide strategic...Work at officeWork from home$200k - $240k
...Associate Director, Regulatory Affairs Operations At Merida Biosciences, we are pioneering true precision medicines for antibody-driven diseases. We specifically target pathogenic antibodies and their cellular sources with bespoke Fc biotherapeutics engineered to selectively...Work at officeLocal area$210.4k - $331.1k
Job DescriptionDepartment- Global Regulatory Affairs and Clinical Safety - Vaccine & Infectious DiseaseBrief Description of Position-The Regulatory Affairs Headquarters Principal Scientist is responsible for development and implementation of global regulatory strategy...Full timeFor contractorsLocal areaWorldwideFlexible hours$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- ...matters for patients – realizing a world where people with immune‑mediated diseases can live 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...For contractorsLocal area2 days per week
- ...The Director of Regulatory Affairs provides strategic and operational leadership to the development and commercialization of products for one or more of the Company’s clinical programs. Reporting to the SVP, Regulatory Affairs, the right experienced candidate will be...
$189k - $246k
...Department: 107000 Regulatory Location: San Diego, USA- Remote Position Summary The Director, Regulatory Affairs Strategy is responsible for developing and executing global regulatory strategies for Phase 2 and Phase 3 development programs to support successful clinical...Temporary workLocal areaRemote workWeekend work- ...Job Title: Executive Director, Global Regulatory Affairs Department: Regulatory Affairs Reports To: Vice President, Regulatory Affairs / Sr. Vice President, Regulatory Affairs Location: Boston, MA Date Prepared: March 27, 2026 Job Summary The Executive Director, Global...
- ...evolving clinical‑stage pipeline. This individual will work closely with the CMC, Quality Assurance, Clinical Drug Supply, and Regulatory Affairs teams to ensure the successful planning, development, and delivery of CMC regulatory strategy across programs. The ideal...Flexible hours
$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- ...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...
- ...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...
- ...Veeva Systems, Inc. in Boston, MA seeks a Mastery-level Regulatory Information Management leader focused on growing the Regulatory product market share. You will bridge complex regulatory requirements with modern software solutions and act as the ultimate authority on...
$220k - $290k
...innovative combination therapy in the U.S. and are exploring regulatory pathways for Europe and Japan. We are continuing to... ...the Corporation’s short and long‑term plans. The Senior Director, Regulatory Affairs has foresight, is action oriented, a problem‑solver, is a...Temporary workFor contractorsWork at officeWeekday work- ...Executive Director, Regulatory Affairs About the Company Innovative biotechnology (BioTech) company specializing in precision therapies for autoimmune & inflammatory diseases Industry Biotechnology Type Privately Held, VC-backed Founded...
$210.4k - $331.1k
...Job Description Regulatory Affairs Headquarters Principal Scientist is responsible for the development and implementation of global regulatory strategy for their assigned projects in the Vaccines and Infectious Disease therapeutic area. Responsibilities Serve as the single...For contractorsWorldwide$183.55k - $275.32k
...Director/Sr. Director, Regulatory Labeling Strategy, Advertising, and Promotion, Regulatory Who we are: At Agios, we are fueled by connections to transform... .... Director: 10+ years of experience in Regulatory Affairs within the biopharmaceutical industry. 7+ years experience...Temporary workLocal areaRemote workWork from homeFlexible hours3 days per week- ...Beeline Medicines is seeking an Executive Director, Regulatory Affairs to lead global regulatory strategy for multiple programs. The role oversees IND/CTA/NDA/MAA submissions, health authority interactions, and lifecycle management. Hybrid work with on-site days is expected...
- ...Job Description Job Description Associate Director, Regulatory Affairs Location: Boston, MA (Hybrid or East Coast, USA) Employment Type: Full-time, Permanent About the Company Our client is a growing consultancy supporting innovative biotechnology and pharmaceutical...Permanent employmentFull time
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