Sign up to access all features of our service.
  • Job search
  • Favorites
  • Create a CV
    New
  • Salaries
  • Subscriptions

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

Vacancy posted 1 day ago
Similar jobs that could be interesting for youBased on the Director, Global Regulatory Affairs — US/EU Submissions Strategy in Florham Park, NJ vacancy
  • 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

    EmergencyMD

    Convent Station, NJ
    3 days ago
  •  ...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... 
    Suggested
    Worldwide

    Eacademy Sanofi

    Convent Station, NJ
    1 day ago
  •  ...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

    360 IT Professionals

    Madison, NJ
    1 day ago
  • The Executive Director, Reblozyl Marketing Brand Lead at Bristol Myers Squibb will own the U.S. brand strategy for Reblozyl and coordinate with global teams to drive lifecycle management and market access...  ...marketing, sales, medical affairs, and market access, and guiding... 
    Suggested
    Temporary work

    Bristol Myers Squibb

    Madison, NJ
    1 day ago
  •  ...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

    EPM Scientific

    Convent Station, NJ
    3 days ago
  •  ...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 area
    Remote work

    EmergencyMD

    Convent Station, NJ
    4 days ago
  •  ...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 time
    Local area
    Worldwide

    AbbVie Inc.

    Florham Park, NJ
    2 days ago
  • $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

    JobRx, Inc.

    Madison, NJ
    3 days ago
  • 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... 

    Bristol Myers Squibb

    Madison, NJ
    1 day ago
  • EmergencyMD seeks a professional for regulatory oversight responsibilities including all US regulatory submissions and acting as the liaison with the FDA. A Bachelor's degree...  ...reports to the Vice President of Regulatory Affairs. The ideal candidate should possess excellent... 
    Remote work

    EmergencyMD

    Convent Station, NJ
    1 day ago
  • $203k - $267k

     ...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 contractors
    Local area
    Flexible hours

    Pacira BioSciences, Inc.

    Parsippany, NJ
    1 day ago
  • 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

    Kaye/Bassman International

    Parsippany, NJ
    1 day ago
  •  ...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... 

    Kaye/Bassman International

    Parsippany, NJ
    1 day ago
  • 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... 

    Eacademy Sanofi

    Convent Station, NJ
    1 day ago
  • $199.95k - $242.3k

    ## 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 pay
    Full time
    Temporary work
    Part time
    For contractors
    Summer work
    Live in
    Work at office
    Local area
    Remote work
    Flexible hours
    Shift work

    Bristol-Myers Squibb

    Madison, NJ
    12 hours ago
  •  ...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,... 

    Dormont Manufacturing Co

    East Hanover, NJ
    3 days ago
  • 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... 

    HUTCHMED

    Florham Park, NJ
    2 days ago
  • $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 time
    Work at office
    Local area
    2 days per week
    3 days per week

    Shionogi Inc. (U.S.)

    Florham Park, NJ
    1 day ago
  • 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... 

    BioSpace

    Convent Station, NJ
    1 day ago
  • 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 Search
    Local area

    Hatch Global Search

    Florham Park, NJ
    1 day ago
  • $240.94k - $291.96k

     ...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 time
    Temporary work
    Remote work

    Bristol Myers Squibb

    Madison, NJ
    1 day ago
  • $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 pay
    Full time
    Temporary work
    Part time
    For contractors
    Summer work
    Live in
    Work at office
    Local area
    Remote work
    Flexible hours
    Shift work

    Bristol-Myers Squibb

    Madison, NJ
    3 days ago
  • $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 office
    Local area
    Worldwide

    Biontech

    Berkeley Heights, NJ
    12 hours ago
  • 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

    3M HEALTHCARE

    East Hanover, NJ
    3 days ago
  • Daiichi Sankyo, Inc. is seeking an Executive Director for Oncology R&D, Global Clinical Lead, to oversee multi-program development and strategic regulatory submissions. The role drives clinical strategy, partners with CROs and senior management, and aligns development with... 

    Daiichi Sankyo

    Basking Ridge, NJ
    1 day ago
  • $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 office
    Local area
    Remote work
    2 days per week

    Perrigouk

    Convent Station, NJ
    1 day ago
  • 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... 

    Eacademy Sanofi

    Convent Station, NJ
    1 day ago
  •  ...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

    EmergencyMD

    Convent Station, NJ
    3 days ago
  • $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 time
    For contractors
    Work at office
    Local area
    Flexible hours

    Gilead Sciences

    Parsippany, NJ
    29 days ago
  •  ...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

    EPM Scientific

    Convent Station, NJ
    3 days ago

Do you want to receive more vacancies?

Subscribe and receive similar vacancies to Director, Global Regulatory Affairs — US/EU Submissions Strategy. Be the first to apply!