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

Regulatory Strategy Lead — US & Canada

BioSpace

AbbVie in the United States is seeking a Senior Manager Regulatory Affairs to lead regulatory strategy for US and Canada, ensuring timely submissions and compliance across therapeutic areas. The role requires collaboration across Regulatory, Clinical Development, Legal, and Commercial teams. The position supports a hybrid work schedule with in-office and remote days and will operate from major US sites including Cambridge, MA, Lake County IL, Florham Park NJ, or Irvine CA as needed. #J-18808-Ljbffr BioSpace

Vacancy posted 3 days ago
Similar jobs that could be interesting for youBased on the Regulatory Strategy Lead — US & Canada in Cambridge, MA vacancy
  • AbbVie is seeking a Senior Manager Regulatory Affairs to lead Global Regulatory Strategy for US & Canada. You will shape regulatory plans for on-market and development products and ensure compliance with US/Canada requirements, coordinating with global teams. You will liaison... 
    Regulatory

    Regulatory Jobs

    Cambridge, MA
    4 days ago
  • AbbVie's Senior Manager Regulatory Affairs, Global Reg Strategy US & Canada, is responsible for developing and implementing regulatory strategy for US and Canada, ensuring alignment with GRPT and regulatory requirements. The role interfaces with FDA and coordinates submissions... 
    Regulatory

    AbbVie

    Cambridge, MA
    1 day ago
  • AbbVie Inc. in the United States seeks a Senior Manager Regulatory Affairs to lead regulatory strategy for US & Canada, ensuring alignment with GRPT and business needs. You will gather data to support filings and enable commercialization while liaising with Health Authorities... 
    Regulatory

    AbbVie Inc.

    Cambridge, MA
    1 day ago
  • $124.5k - $236.5k

    Senior Manager Regulatory Affairs, Global Reg Strategy US & Canada Full-time Salary Min: 124500 Salary Max: 236500 Workday Global Grade: 19 Compensation: USD...  ...Therapeutic Area and supports the Manager (Global Regulatory Lead (GRL), Associate Director, or Director), in the... 
    Regulatory
    Full time
    Work at office
    Remote work

    AbbVie

    Cambridge, MA
    1 day ago
  • Alnylam seeks an Associate Director of Regulatory Affairs Strategy to lead regulatory strategy for early programs, coordinate submissions, and oversee US interactions with health authorities. The role requires cross-functional collaboration, multidisciplinary team involvement... 
    Regulatory
    2 days per week

    Regulatory Jobs

    Cambridge, MA
    5 days ago
  • Keurig Dr Pepper seeks a Manager, HR Compliance to lead compliance strategy across the U.S. and Canada, including governance, policy development, and risk...  ...mitigation. This role partners with Legal Counsel, audits, regulatory reporting, HR policy development, and employee... 
    Regulatory

    Keurig Dr Pepper

    Burlington, MA
    1 day ago
  • Sarepta Therapeutics is seeking a regulatory affairs professional for a US-based remote role. You will lead regulatory activities for clinical trials, coordinate submissions...  ...-functional teams to implement regulatory strategies and ensure compliance with evolving guidelines... 
    Regulatory
    Remote job

    Regulatory Jobs

    Cambridge, MA
    5 days ago
  •  ...in Cambridge, MA seeks an Associate Director to define and lead global regulatory strategies for complex programs, providing strategic and tactical...  ...FDA and global regulatory requirements. The role oversees US FDA submissions, stakeholder communications, and staff mentorship... 
    Regulatory

    Takeda

    Cambridge, MA
    2 days ago
  • Takeda is seeking a Global Regulatory Labeling Strategy Lead for Plasma-Derived Therapies to drive strategic labeling across CCDS, US and EU labels while coordinating with internal stakeholders to ensure regulatory compliance and successful product evolution. This role... 
    Regulatory
    Remote job

    Regulatory Jobs

    Cambridge, MA
    4 days ago
  •  ...Therapeutics is seeking a Senior Director, Brand Lead – US who will be responsible for developing and executing the US brand strategy and commercial plan for ficerafusp alfa,...  ...programs Partner with Medical Affairs, Regulatory, Legal/Compliance, Market Access,... 
    Regulatory
    Work at office
    Local area
    3 days per week

    Bicara Therapeutics, Inc.

    Boston, MA
    2 days ago
  • Sanofi in the US seeks a senior medical leader to head the One...  ...will build and execute medical strategy across Rare Disease and Rare Blood...  ...healthcare systems. You will lead talent, budget, and...  ...decisions, and ensure compliance with regulatory standards while partnering with... 
    Regulatory
    Home office

    Sanofi

    Cambridge, MA
    1 day ago
  • $155k - $213.5k

     ...the recruiter directly. About This Role The US Lifecycle Management Lead is a senior individual contributor accountable for...  ...launches are supported by robust supply, quality, regulatory, and flow‑of‑goods strategies. You will partner closely with Asset Leaders and... 
    Regulatory
    Full time
    Temporary work
    Local area

    Biogen

    Cambridge, MA
    4 days ago
  • Job title: US Neurology and Immunology Asset/Indication Lead Location: Cambridge, MA About The Job Sanofi's specialty...  ..., value-based contracting strategies, etc. Set HEOR evidence generation...  ...Neurology and Immunology launch assets Regulatory & Compliance Knowledge Apply... 
    Regulatory
    Contract work

    BioSpace

    Cambridge, MA
    4 days ago
  •  ...Job Description Strategy Lead, Business Strategy \n \n MassMutual is a Fortune 100 financial...  ...industry trends, competitive dynamics, regulatory developments, emerging technologies, and...  ...the application process, please contact us and share the specifics of the... 
    Regulatory
    Temporary work

    MassMutual

    Boston, MA
    5 days ago
  • ## Senior Director, US Market Access Strategy, Povetacicept (POVE)Applylocations: Boston, MAtime type:...  ...Director, US Market Access Strategy to lead market access initiatives for **...  ...’t and commercial payers, policy, and regulatory environment* Pharmacy and medical benefit... 
    Regulatory
    Contract work
    Summer work
    Remote work
    Relocation
    Flexible hours
    2 days per week
    3 days per week

    Vertex Pharmaceuticals

    Boston, MA
    2 days ago
  •  ...applicable law. Job Purpose The Director – US RA CMC Team Leader & Innovation, Global CMC Regulatory Affairs is responsible for leading the CMC Regulatory Affairs team with a...  ...management, and post-approval regulatory strategy for FDA and internationally approved... 
    Regulatory

    Dechra

    Boston, MA
    1 day ago
  • $109.24k - $163.87k

     ...Reports to: Senior Director, Global Regulatory Strategy About Alexion  For over 30 years, Alexion...  ...of people living with rare diseases. We lead with breakthrough science, deep disease...  ...The Senior Manager, Regulatory Affairs US lead will be responsible for leading,... 
    Regulatory
    Temporary work
    Work at office
    Boston, MA
    5 days ago
  • Sanofi's HEVA team in Cambridge, MA is seeking a Systemic Mastocytosis/Emerging Indication HEOR Strategy Specialist to lead US-focused HEOR for AYVAKIT and new assets. You will design economic models, conduct RWE studies, and prepare payer dossiers to support US access... 

    Sanofi Group

    Cambridge, MA
    4 days ago
  • $177k - $278.08k

     ...Purpose: Defines, develops and leads global strategies to maximize global regulatory success towards achievement of program...  ...solutions. Accountable for all US FDA submissions and approvals of...  .... Knowledge of FDA, EU, Canada, ROW and post-marketing a plus.... 
    Regulatory
    Minimum wage
    Full time
    Local area
    Remote work

    Regulatory Toolkit

    Boston, MA
    4 days ago
  • The Director, Medical Strategy - Rare Emergency Medicine will serve as a key member of the US Medical team, responsible for developing...  ...Development, Commercial, Regulatory, Market Access, and other key...  ...commercialization and post-marketing. Lead efforts to seek expert... 
    Regulatory
    Immediate start

    SERB Pharmaceuticals

    Cambridge, MA
    2 days ago
  • $177k - $278.08k

     ...Takeda as a Director, Global Regulatory Lead Oncology where you will be part...  ...will set global regulatory strategy and lead major submissions for...  .... Accountable for all US FDA submissions and approvals...  ...is a must. Knowledge of EU, Canada, ROW is a plus. Experience... 
    Regulatory
    Minimum wage
    Full time
    Local area
    Remote work
    Worldwide

    Regulatory Toolkit

    Boston, MA
    4 days ago
  • Stealth Co is seeking a part-time Regulatory Affairs Consultant to guide global regulatory strategy for novel therapeutics. You will advise leadership and work with...  ...internal teams to align regulatory and clinical plans, lead IND submissions, and plan FDA interactions in a... 
    Regulatory
    Remote job
    Part time
    Flexible hours

    Stealth Co

    Cambridge, MA
    4 days ago
  • Scholar Rock is seeking an Associate Director, Regulatory Strategy in the greater Boston area to lead the development and execution of regulatory plans for clinical and pipeline programs. This role represents regulatory affairs on cross-functional teams and directs submissions... 
    Regulatory

    Scholar-Rock

    Cambridge, MA
    2 days ago
  •  ...Inc. seeks a senior Business Engagement Lead to partner with Clinical Development and...  ...role emphasizes stakeholder management, regulatory compliance, and collaboration with product...  ...enable faster submissions and better outcomes for patients. #J-18808-Ljbffr Jobleads-US
    Regulatory

    Jobleads-US

    Boston, MA
    1 day ago
  • ClinLab Solutions Group in Watertown, MA is expanding its regulatory capacity. The Global Regulatory Lead will take ownership of regulatory strategy and execution for an assigned program, reducing reliance on external consultants and closing timeline gaps created by competing... 
    Regulatory

    ClinLab Solutions Group

    Watertown, MA
    3 days ago
  • Takeda is seeking a Director, Global Regulatory Lead Oncology to set global regulatory strategy and lead major submissions for high-impact oncology programs. You will serve as GRL on GPTs, coordinate with global teams, and ensure FDA submissions and other major filings... 
    Regulatory

    USA - 3316 Takeda Development Center Americas, Inc.

    Cambridge, MA
    5 days ago
  •  ...biopharma company focused on muscle biology, is seeking an Associate Director, Regulatory Strategy in the greater Boston area. You will shape regulatory strategy for clinical and pipeline programs and lead agency communications to advance anti-myostatin therapies and other... 
    Regulatory

    Regulatory Jobs

    Cambridge, MA
    4 days ago
  • Draper is seeking a Treasury Manager in Cambridge, MA to lead the Treasury function, supervise the Treasury Analyst, and oversee...  ...internal teams and external providers to support financial strategy and regulatory reporting. The ideal candidate has 5-7 years of progressive... 
    Regulatory

    Draper Labs

    Cambridge, MA
    3 days ago
  • Sarepta Therapeutics is seeking a Global Regulatory Lead to drive high quality regulatory documents (INDs, CTAs, NDAs) and lead interactions...  ...periodic international meetings. You will craft regulatory strategies, ensure compliance, and guide teams through FDA engagements,... 
    Regulatory

    Sarepta Therapeutics

    Cambridge, MA
    1 day ago
  •  ...Derived Therapies Procurement to lead end-to-end sourcing, category strategy, and supplier relationships...  ...programs, optimize total cost of ownership, and ensure compliance with regulatory standards across equipment, services, and real estate. #J-18808-Ljbffr Jobleads-US
    Regulatory

    Jobleads-US

    Cambridge, MA
    1 day ago

Do you want to receive more vacancies?

Subscribe and receive similar vacancies to Regulatory Strategy Lead — US & Canada. Be the first to apply!