Director, Global Regulatory Strategy
BioSpace
A global biopharmaceutical company is seeking a Director of Regulatory Affairs to lead the Global Regulatory Strategy. This role involves developing strategies for securing market approval, ensuring compliance with regulatory requirements, and mentoring team members. Candidates should have a Bachelor's degree in life sciences and over 7 years of regulatory experience, along with strategic leadership skills. This position is crucial in coordinating cross-functional teams and managing projects to navigate complex regulations. #J-18808-Ljbffr BioSpace
$180k - $245k
...Therapeutics is seeking an experienced and strategic Director of Regulatory Affairs to lead and support global regulatory efforts across our development programs... ...for developing and executing regulatory strategies that support global product development and registration...Suggested$196.7k - $353.4k
The RoleModerna is seeking an individual to lead development and execution of global regulatory strategy for programs in its oncology portfolio. This leader will shape regulatory pathways for novel, first-in-class therapeutics and drive successful global development and...SuggestedPermanent employmentFull timeWork at officeWork from home$182k
...@abbvie on LinkedIn, ( Facebook, Instagram ( , X ( and YouTube. ( Job Description The Director Regulatory Affairs Global Regulatory Lead (GRL II), Global Regulatory Strategy, is responsible for developing and implementing global strategies to secure and maintain market...SuggestedLocal areaWorldwide$167k - $300.7k
...The Role Moderna, Inc. is seeking a Director of Regulatory Strategy to support select programs within the rare, autoimmune and oncology portfolios... ...markets. The Director will be a strategic leader within Global Regulatory Science, responsible for developing and executing...SuggestedPermanent employmentWork at officeWork from home- Vertex Pharmaceuticals Inc is seeking a Director of Chemistry Manufacturing Controls (CMC) to lead a Regulatory CMC team responsible for global regulatory strategies and submissions across small molecule programs. The role emphasizes strategic leadership, Health Authority...Suggested
- ...experienced labeling professional to join our labeling strategy team. This team is responsible for developing... ...or Philadelphia, PA Key Responsibilities Represent Global Labeling on product-specific Global Regulatory Teams and other cross-functional product, development...Local area
$189k - $246k
Travere Therapeutics, located in Boston, is seeking a Director of Regulatory Affairs Strategy. The role involves developing and executing global regulatory strategies for Phase 2 and Phase 3 drug development programs. As the regulatory lead, you will ensure compliance,...Remote job- Akebia Therapeutics in Cambridge, MA is seeking a Director of Regulatory Affairs - Labeling. This high-visibility role shapes global labeling strategy and partners cross-functionally to ensure labeling complies with FDA and global requirements. You will influence senior...Work at officeRelocation
- Overview Moderna Therapeutics is seeking an Associate Director of Regulatory Strategy to support programs within the oncology franchise in one of... ...vaccines based on messenger RNA technology in the US and other global markets. Responsibilities Serve as the global...
- ...company in Cambridge, MA, seeks an experienced Associate Director of Regulatory Strategy to lead oncology therapeutic programs. This role requires... ...particularly in oncology, to ensure alignment between US and global strategies. Exceptional communication skills and...
$211.5k - $258.5k
...for patients - realizing a world where people with immune‑mediated diseases can live life fully. Job Summary The Director, Regulatory Strategy - Global Regulatory Lead is responsible for developing and leading the integrated global regulatory strategies for the company...Local areaFlexible hours2 days per week$200k - $265k
...opportunity to gain new and challenging work experiences and create an unparalleled, direct impact.The OpportunityLeads the global regulatory strategy, submission planning, and health authority engagement for Nemolizumab across all approved and development-stage...Full timeTemporary workWork experience placementWork at officeWorldwide- ...Takeda is looking for a Director, Global Regulatory Lead Oncology in Boston, MA. This role encompasses setting the global regulatory strategy and overseeing all regulatory activities for high-impact oncology programs. You will collaborate with cross-functional teams to...
- ...seeks a Chemistry Manufacturing Controls Manager to oversee regulatory CMC submissions and strategic interactions with agencies.... ...partner with development and manufacturing teams to shape global CMC strategies for investigational and marketed products, while supporting...Remote work
- 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...
$200k - $300k
A biopharmaceutical company in Cambridge is seeking a Director or Senior Director of Regulatory Strategy. This role involves developing and implementing global regulatory strategies for clinical programs and leading interactions with regulatory authorities. Candidates should...- Moderna, Inc. is seeking a Director of Regulatory Strategy to lead global regulatory plans for assigned programs in rare, autoimmune and oncology portfolios. You will shape strategy, communicate risks and opportunities, and negotiate with health authorities in the US and...
- Beeline Medicines in Boston is seeking a Director, Regulatory Strategy - Global Regulatory Lead to shape integrated global regulatory plans for early-stage immunology and inflammation programs, including lupus. You will guide development teams and coordinate across FDA...
- Vertex Pharmaceuticals in Boston seeks a Director, CMC to lead global regulatory strategies for the small molecule portfolio, overseeing submissions and Health Authority interactions. The role drives governance, mentors Regulatory CMC staff, and champions AI-enabled capabilities...
- ...United States is seeking an experienced Associate Director / Director of Regulatory Affairs to lead global regulatory activities and ensure compliance with applicable... .... This hands-on role will influence regulatory strategy, prepare and manage submissions, and navigate...
- Discover International is seeking an Associate Director or Director to lead Global Regulatory Affairs on an initial contract. You will drive regulatory strategy, lead FDA interactions and manage submissions for multiple development programs, with potential conversion to...Remote jobPermanent employmentContract work
- Monte Rosa Therapeutics, Inc is seeking a Director of Regulatory Affairs based in Boston. This strategic role involves developing and executing regulatory strategies to support global product development, particularly in immunology. The successful candidate will have at...
- Relay Therapeutics in Cambridge, MA is seeking a motivated regulatory professional to join their dynamic team. You will support innovative regulatory strategies and manage global submissions including IND, CTA, NDA, and MAA. The ideal candidate has a B.S./M.S. with 2+ years...
- Vertex Pharmaceuticals Incorporated in Boston, MA, is seeking a Regulatory Strategy Associate Director to oversee the global regulatory strategy for development programs and marketed products. The ideal candidate will have a strong understanding of regulatory affairs frameworks...
$154.4k - $242.55k
...changing therapies to patients worldwide.This role is within the Global Regulatory Affairs (GRA) Chemistry Manufacturing & Controls (CMC) and... ...CMC investigational, registration and/or post-approval strategies for assigned products. RA CMC member on the Global Regulatory...Minimum wageTemporary workLocal areaRemote workWorldwide$154.4k - $242.55k
...DescriptionObjective / Purpose: Defines, develops and leads global strategies to maximize global regulatory success towards achievement of program objectives for... ...regional counterparts.Accountabilities:The Associate Director will be responsible for complex or highly complex or...Minimum wageTemporary workLocal areaRemote work$190k - $210k
...treatment paradigm and access a $15 billion global market opportunity. Our follow-... .... About the Role Associate Director, Global Regulatory Affairs, Compliance As the... ...the Senior Director, Global Regulatory Strategy, you will play a key role in advancing...Full timeWork at officeFlexible hours2 days per week$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 and...Hourly payFull timeTemporary workWork at officeWorldwideFlexible hours3 days per week$268.2k - $402.2k
Job DescriptionGeneral Summary:The Executive Director, Regulatory Strategy will serve as a seasoned regulatory leader with expert technical and tactical... ...the development and implementation of innovative global regulatory strategies for product development and commercialization...Full timeSummer workLocal areaRemote workFlexible hours2 days per week$238k - $374k
...true to the best of my knowledge.Job DescriptionExecutive Director, Global Regulatory Affairs CMC Early DevelopmentAre you looking for a... ...leadership to deliver innovative, compliant global CMC regulatory strategies and submissions for small molecule and biologic products...Minimum wageTemporary workLocal areaRemote work
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