Director, Global Regulatory Affairs — US/EU Submissions Strategy
HUTCHMED
HUTCHMED is seeking a (Sr.) Director of Regulatory Affairs to establish and lead the Regulatory Affairs function. This role involves supporting the global product team in developing registration strategies for product approvals in both the US and EU. The ideal candidate will provide regulatory guidance leveraging their expertise, manage submissions, and develop timelines in coordination with global partners. Requirements include a BS in health sciences, advanced degree preferred, and a proven track record in regulatory filings. #J-18808-Ljbffr HUTCHMED
- EmergencyMD is seeking a regulatory CMC specialist to provide global regulatory support throughout the product lifecycle in Morristown, New Jersey. The role involves managing high-quality CMC regulatory submissions and ensuring timely execution of corporate goals. The ideal...Suggested
- ...role, you will contribute to global regulatory strategies for medical device and combination... ...of experience in regulatory affairs and your educational... ...preparing high-quality regulatory submissions and supporting compliance activities. Join us to make a significant impact...SuggestedWorldwide
- ...company based in New Jersey is seeking a professional in Global Medical Affairs. This role requires accountability for deliverables,... ...to develop sound medical rationale and support regulatory submissions. Join us to make a significant impact in the medical domain. #J...Suggested
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- ...providing strategic regulatory leadership and... ...management of regulatory submissions, including clinical... ...Head of Regulatory Affairs. Key... ...to and help shape global and U.S. regulatory strategies aligned with development... ...applications in the US (NDA submission experience...Suggested
- ...providing strategic regulatory advice and... ...all of Altimmune's US regulatory applications... ...relevant US regulatory submissions, responses, and... ..., Regulatory Affairs. Essential Functions... ...development of regulatory strategy and writing of... ...regulations and global regulatory...Local areaRemote work
- ...information about AbbVie, please visit us at . Follow @abbvie on... .... Job Description The Director Regulatory Affairs Global Regulatory Lead (GRL II), Global Regulatory Strategy, is responsible for... ...addition to the US, such as EU or Japan. Strong global drug...Full timeLocal areaWorldwide
$225k - $305k
...you’ll guide the strategy, compliance, and impact... ...team overseeing US Advertising and... ..., ensuring timely submissions. Develop and implement... ...as the senior regulatory representative on... ...within the Regulatory Affairs area and with... ...framework and procedures globally, including how...Work at office- Bristol Myers Squibb is seeking a Director, US Regulatory Lead to oversee regulatory strategy and execution for the Immunology and Cardiovascular therapeutic... ...manage Health Authority interactions and lead NDA submissions. With responsibilities that include providing strategic...
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...like you. Why Join Us? At Pacira, every... ...and implements regulatory projects in support... ...area of clinical strategy. The position will... ...responsibilities may be global, regional, or... ...assigned. Regulatory Affairs Clinical-... ...including for regulatory submissions documents and HA...For contractorsLocal areaFlexible hours- Position: The Director will direct, manage... ...and implement regulatory projects in... ...across clinical strategy areas. The position... ...may be global, regional, or local... ...including regulatory submission documents and... ...regulatory affairs strategies, tactics... ...in the US pharmaceutical...Local area
- ...Bassman International is leading a search for a Senior Director, Global Regulatory Clinical Strategy. This role focuses on overseeing global regulatory... ...15+ years of experience in pharmaceutical Regulatory Affairs, providing strategic guidance and complex regulatory solutions...
- Job Title: Director, US Regulatory Affairs - Advertising and Promotion (Hybrid) Location: Cambridge, MA... ...opportunities. We are an innovative global healthcare company with one purpose:... ...Develops and implements regulatory strategies for marketed products within their product...
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## Director, Regulatory CMC - Cell TherapyMadison - Giralda - NJ... ...job**Working with Us** Challenging. Meaningful... ...direction based on global regulatory guidelines... ...oversee preparation of CMC submissions while ensuring... ...effective global regulatory strategies in coordination with...Hourly payFull timeTemporary workPart timeFor contractorsSummer workLive inWork at officeLocal areaRemote workFlexible hoursShift work- ...Talent for the United States to lead the integrated talent agenda for the US business unit, in partnership with the North America Head of Talent & Culture and aligned with the global HR strategy. You will drive talent strategy, performance reviews, succession planning,...
- The (Sr.) Director, Regulatory Affairs role will establish Regulatory... ...She will support the global product team in the... ...global registration strategies for our pipeline which... ...product/s within US and EU. The ideal candidate... ...approval and timely submission of regulatory filings...
$260k - $295k
Overview Join to apply for the Senior Director, Global Commercial Strategy role at Shionogi Inc. (U.S.) . The... ...functional teams dispersed across Japan, US and Europe to create value for... ...reimbursement, health outcomes, clinical, regulatory, and project management....Full timeWork at officeLocal area2 days per week3 days per week- Job title: Director, US Advertising and Promotion, Global Regulatory Affairs Location: Morristown, NJ / Cambridge, MA About The Job As the Director, US Advertising... ..., labeling, product defense, and development strategies for assigned product(s). The Director is responsible...
- Hatch Global Search is seeking a Tax Manager to oversee tax operations, ensuring compliance at federal, state, and local levels. The... ...position offers a dynamic global environment and opportunities for professional growth in tax strategies. #J-18808-Ljbffr Hatch Global SearchLocal area
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...bms.com/working-with-us. Position Director, US Regulatory Lead, GRS Position... ...oversee regulatory strategy and execution for Immunology... ...upcoming NDA submission. The incumbent may also serve as Global Regulatory Lead (GRL... ...experience in regulatory affairs (e.g. > 4-7 years),...Full timeTemporary workRemote work$188.45k - $228.35k
## Director, Global S&OP Capability OwnerMadison - Giralda - NJ - USFind... ...with this job**Working with Us** Challenging. Meaningful. Life... ...and executing the overall strategy for continued excellence across... ....* Ensure compliance with regulatory requirements and company...Hourly payFull timeTemporary workPart timeFor contractorsSummer workLive inWork at officeLocal areaRemote workFlexible hoursShift work$166k - $203k
...The Associate Director, Regulatory Affairs (Advertising and Promotion... ...review and approval of US promotional materials... ...regulatory compliance/strategy related to... ...responsible for all submission types made to OPDP/APLB... ...Medical Affairs, Legal, Global Regulatory Affairs, Labeling...Work at officeLocal areaWorldwide- Novartis seeks a Director of US Market Access Strategy (Neuroscience) to lead access launches from East Hanover, NJ or Cambridge, MA with remote options... ...needs dictate. The role requires coordinating with US/Global product teams, developing a 3-5 year access plan, and partnering...Remote work
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$225k - $275k
Sr Director of Regulatory Affairs - North America Location: Morristown, NJ, US, 07960 Description Overview As Senior... ...Category Regulatory strategies into effective local... ...management, and submission readiness, working in... ...regulatory pathways, and global dossier expectations...Work at officeLocal areaRemote work2 days per week- Eacademy Sanofi is seeking a Director for US Regulatory Affairs focused on Advertising and Promotion. This hybrid role demands a strong regulatory... ...cross-functional teams and develop innovative regulatory strategies. Enjoy a comprehensive benefits package, including health...
- ...responsible for providing global regulatory CMC support throughout... ...(e.g., regulatory strategies, preparing CMC filings and submissions to regulatory applications... ...the Head of Regulatory Affairs. Essential Functions Responsible... ...FDA Regulations, EU Directives, and global...Local area
$302.01k - $390.83k
...The Executive Director, Head of Precision Medicine Regulatory is responsible... ...wide regulatory strategy for precision... ...through global registration and... ...Global Regulatory Affairs Oncology and... ...requirements (such as US FDA and EU IVDR).... ...to premarket submission, IVD partnering...Full timeFor contractorsWork at officeLocal areaFlexible hours- ...Morristown, New Jersey, is seeking a strategic regulatory leader to oversee U.S. regulatory... .... This individual will lead regulatory submissions and serve as the primary liaison with... ...least 6 years of experience in regulatory affairs within the biotech or pharmaceutical...Work at office
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