Global Regulatory Affairs Executive Director
Initial Therapeutics, Inc.
Beeline Medicines is seeking an Executive Director, Regulatory Affairs to lead global regulatory strategy for assigned programs. You will serve as the Global Regulatory Leader and US Regulatory Lead, guiding IND/CTA/NDA/MAA submissions and lifecycle management across regions. The role requires extensive experience with regulatory submissions, health authority interactions, and cross-functional leadership. Hybrid work schedule with on-site expectations and potential for expanded leadership #J-18808-Ljbffr Initial Therapeutics, Inc.
$238k - $374k
...true to the best of my knowledge.Job DescriptionExecutive Director, Global Regulatory Affairs CMC Early DevelopmentAre you looking for a patient-... ...that will inspire you and support your career? Join us as Executive Director, Global Regulatory Affairs CMC Early Development...SuggestedMinimum wageTemporary workLocal areaRemote work$238k - $374k
..., we 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...SuggestedMinimum wageTemporary workWork at officeLocal areaRemote workWorldwide$170k - $267.5k
...Who we are looking forThe Global Head of Market Surveillance Compliance is a senior leadership... ...-enabled, and aligned with applicable regulatory expectations across jurisdictions. The... .... You will help us build resilience and execute day to day deliverables at our best....SuggestedFull timeTemporary workFlexible hours- Treeline in the United States is seeking an experienced Associate Director / Director of Regulatory Affairs to lead global regulatory activities and ensure compliance with applicable laws and guidelines. This hands-on role will influence regulatory strategy, prepare and...Suggested
- A leading pharmaceutical company is looking for a Director of Regulatory Affairs to provide strategic and operational leadership in developing and... ...communication and leadership skills. This role is vital for supporting ongoing global clinical studies. #J-18808-Ljbffr Noema Pharma AGSuggested
$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...Permanent employmentFull timeWork at officeWork from home$200k - $265k
...direct impact.The OpportunityLeads the global regulatory strategy, submission planning, and health... ..., ensuring regulatory activities are executed in accordance with global regulatory requirements... ...Accountable for the Global Regulatory Affairs team supporting nemolizumab and for...Full timeTemporary workWork experience placementWork at officeWorldwide$178.5k
Posting Description MANAGING DIRECTOR, GLOBAL STRATEGIC ALLIANCES, Computer Science and Artificial Intelligence, will establish the goals... ...experience in relating to and negotiating with senior corporate executives; ability to manage multiple objectives and tasks and meet...Full timeVisa sponsorshipNight shift$180k - $245k
...Therapeutics is seeking an experienced and strategic Director of Regulatory Affairs to lead and support global regulatory efforts across our development programs... ...candidate will be responsible for developing and executing regulatory strategies that support global product...$177k - $278.08k
...changing therapies to patients worldwide.This role is within the Global Regulatory Affairs (GRA) Chemistry Manufacturing & Controls (CMC) and Devices... ...develops the regulatory CMC strategy and leads the execution of regulatory CMC investigational, registration and post-approval...Minimum wageTemporary workLocal areaRemote workWorldwide$177k - $278.08k
...bring life-changing therapies to patients worldwide.The Director Global Regulatory Affairs, Neuroscience is responsible for developing innovative global... ...to ensure the global regulatory strategy is updated and executed, ensuring global regulatory compliance and/or oversees...Minimum wageTemporary workLocal areaRemote workWorldwide$182k
...Instagram ( , X ( and YouTube. ( Job Description The Director Regulatory Affairs Global Regulatory Lead (GRL II), Global Regulatory Strategy, is... ...assessments and regulatory recommendations to executive management. Proactively informs AST and cross functional...Local areaWorldwide- ...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...
$167k - $300.7k
...The Role Moderna, Inc. is seeking a Director of Regulatory Strategy to support select programs within the rare... ...Director will be a strategic leader within Global Regulatory Science, responsible for developing and executing regulatory plans for assigned programs, and...Permanent employmentWork at officeWork from home- ...Head of Global Regulatory Advertising and Promotion About the Company Industry shaping biopharmaceutical company Industry Biotechnology... ...Advertising and Promotion to lead the development and execution of the global regulatory strategy for advertising and...
$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- 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
- ...or Philadelphia, PA Key Responsibilities Represent Global Labeling on product-specific Global Regulatory Teams and other cross-functional product, development... ...biopharmaceutical industry in fields of Regulatory Affairs, Pharmacovigilance, and/or Medical Writing/Communications...Local area
- 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...
- ...Manufacturing Controls Manager to oversee regulatory CMC submissions and strategic... ...development and manufacturing teams to shape global CMC strategies for investigational and marketed... ...a strong background in regulatory affairs, cGMP, and experience with Veeva for submissions...Remote work
- 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...
- ...Pharmaceuticals Incorporated in Boston, MA, is seeking a Regulatory Strategy Associate Director to oversee the global regulatory strategy for development programs and... ...will have a strong understanding of regulatory affairs frameworks and a minimum of 8 years experience in...
- 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...
- 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...
- 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...
- 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
- 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...
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