Global Regulatory Director - GI & Inflammation
$153.6k - $241.34kTakedaPharmaceutical Nordics AB
A leading pharmaceutical company is seeking an Associate Director, Global Regulatory Affairs for GI & Inflammation programs in Boston, MA. This role involves leading regulatory strategies, maintaining compliance, and coordinating with health authorities. The ideal candidate will hold a scientific degree, possess extensive experience in regulatory affairs, and demonstrate strong negotiation and communication skills. The position offers a hybrid work model and a competitive salary ranging from $153,600 to $241,340, along with comprehensive benefits. #J-18808-Ljbffr
- ...Takeda in Boston, MA seeks a Director of Regulatory Strategy to define and lead global regulatory strategies for complex programs, collaborating cross-functionally to ensure compliance and timely submissions. The role leads GRTs, coordinates health authority interactions...Geographic information system
- ...Senior Director, Global Regulatory Lead, GI & Inflammation About the role: The Global Regulatory Leads, Senior Director is responsible for ensuring that the organization gains regulatory approval for new products and product amendments, while maintaining the currency of...Geographic information systemFull timeLocal area
$153.6k - $241.34k
...Associate Director, Global Regulatory Affairs – GI & Inflammation Apply for the role at TakedaPharmaceutical Nordics AB. Job Description Associate Director responsible for regulatory affairs for GI & Inflammation programs. Provides strategic and tactical advice, leads...Geographic information systemFull timeTemporary workRemote work- ...A leading pharmaceutical company in Cambridge is seeking a Senior Director, Global Regulatory Lead for GI & Inflammation. This role is critical in ensuring compliance and securing regulatory approvals for new products. The ideal candidate will have over 12 years of experience...Geographic information system
$154.4k - $242.55k
...to shine? Join us as an Associate Director, Global Biomarker Lead, Inflammation, GI2 TAU based in Cambridge, MA reporting... ...Sub-Team (TST) and partners with GI-DDU research, physician scientists,... ...and documents submitted to Regulatory Agencies.• Establish and maintain scientific...Geographic information systemMinimum wageLocal area- ..., GRA Audits, Inspections and Compliance to lead global GCP audits and inspections, ensuring readiness and regulatory compliance. The role partners with Regulatory Leads... ...improve processes across neuroscience, oncology, GI and other areas. You will drive continuous...Geographic information system
- ...Takeda is seeking an Associate Director, Global Biomarker Lead, Inflammation, GI2 TAU, based in Cambridge, MA. You will drive translational biomarker strategies... ...leading the Translational Sub-Team and partnering with GI‑DDU and cross-functional stakeholders. The role...Geographic information system
$195k - $330k
...ll make an impact:Act as the global regulatory strategy lead for Kymera’s... ...across multiple immunology and inflammation (I/I) indications.Ensure... ...preferred but not required.Director: 8-10 years of Regulatory Affairs... ...working in rheumatology, GI, and/or other immunology or...Geographic information systemFlexible hours- ...AstraZeneca seeks a seasoned Regulatory Leader to guide strategic regulatory activities across development, launch, and lifecycle for assigned... ...products. You will influence authorities and collaborate with global teams to shape regulatory strategies and compliance. With 6+...Local area
- ...A leading pharmaceutical company is looking for a Director of Regulatory Affairs to provide strategic and operational leadership in developing... ...strong communication and leadership skills. This role is vital for supporting ongoing global clinical studies. #J-18808-Ljbffr...
- ...Takeda in Boston, MA is seeking a Director of Global Regulatory Affairs, Neuroscience to lead global regulatory strategy across multiple projects, oversee GRTs, and guide cross‑functional teams toward successful submissions. You will manage US FDA submissions, including...
- ...AstraZeneca plc in Cambridge, MA, invites you to shape regulatory strategy across development, commercialization and life cycle management... ...compliance. The role emphasizes collaboration across global, regional, and local regulatory affairs, coaching staff, and staying...Local area
- ...Olema Oncology seeks a Director, Global Regulatory Strategy Lead to guide innovative regulatory strategies across its oncology portfolio. Based in Boston or San Francisco, you will lead cross-functional teams, oversee submissions (INDs, NDA/BLA), and partner with global...
$186.23k - $279.35k
...person.In this role, you will:Provide strategic and operational regulatory leadership to the development, commercialization and life cycle... ...in product teams. Apply knowledge of current local and global Regulatory trends to identifyfuture regulatory requirements and...Full timeTemporary workWork at officeLocal areaWorldwideFlexible hours3 days per week- ...Amgen seeks an Associate Regulatory Affairs Director to oversee cell therapy regulatory strategy and submissions across global regions. You will partner with senior teams to advance innovative therapies through clinical development and guide cross-functional teams on compliance...
- ...AVEO Oncology is seeking an Executive Director, Global Regulatory Affairs to provide strategic and operational leadership for global regulatory activities across the company’s oncology portfolio. You will be accountable for the development and execution of integrated global...
- AbbVie in Cambridge, MA, seeks a Director Regulatory Affairs Global Regulatory Lead (GRL II) for Neuroscience. You will develop global regulatory strategies, lead the GRPT, oversee dossier development, and ensure compliant submissions across US, EU, and other regions....
- Discover International is seeking a Director, Global Regulatory Affairs — Oncology to lead regulatory strategy and execution for oncology programs. You will partner with global clinical development teams to navigate milestones, submissions, and lifecycle activities. The...
- Arbor Biotechnologies is seeking a Director of Regulatory Affairs to lead regulatory strategy across its portfolio, spanning preclinical and early clinical programs. You will serve as the global regulatory lead and primary contact with FDA and other authorities, guiding...
- Repertoire Immune Medicines is seeking an experienced Director of Regulatory Affairs to lead global regulatory strategy for Phase 1/2 oncology programs, based in Watertown, MA with in-office presence at least 3 days a week. The role will own INDs/CTAs, health authority...Work at office3 days per week
$212k - $333.19k
...discovery programs to clinic, The Global Therapeutic Research Lead (GTRL) is... ...will sit on the Gastroenterology and Inflammation Drug Discovery Unit (GI DDU) Leadership Team. Leader for at... ...pharmaceutical industry, including regulatory requirements and commercial...Geographic information systemMinimum wageFull timeLocal areaRemote workWorldwide- ...Takeda Pharmaceutical Company Limited is seeking a senior marketing leader to drive global GI oncology strategy from pre-launch to in-market execution. You will collaborate with cross-functional teams to shape competitive positioning, develop brand plans, and manage campaigns...Geographic information system
$177k - $278.08k
...we push the boundaries of what is possible in order to bring life-changing therapies to patients worldwide.Join Takeda as Director, Global Regulatory Labeling Strategy where you will be responsible for the development and implementation of labeling content and strategy...Minimum wageLocal areaRemote workWorldwide$196.7k - $353.4k
The Role:Moderna Therapeutics is seeking a Sr. Director of Regulatory Strategy to support oncology programs to be based in its Cambridge headquarters... ..., will be relied on to articulate clear and compelling global regulatory strategies, highlighting risks and opportunities...Permanent employmentFull timeWork at officeWork from home$200k - $265k
...ultimate 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- ...Coast) or Copenhagen, Denmark Reporting to : VP, Regulatory Affairs & Quality About Hemab Hemab is... ...MA and Copenhagen, Denmark. The role As Director, Regulatory Affairs, you'll shape and deliver global regulatory strategy for Hemab's development programs...Remote work
$180k - $245k
OverviewMonte Rosa Therapeutics is seeking an experienced and strategic Director of Regulatory Affairs to lead and support global regulatory efforts across our development programs, with a focus on immunology. The ideal candidate will be responsible for developing and executing...$177k - $278.08k
...as follows: Independently develops and leads the execution of regulatory CMC investigational, registration and/or post-approval strategies... ...- technical protocols, reports, etc. to ensure alignment with global regulatory requirements and standards. When in a GRA CMC Product...Minimum wageLocal areaRemote workWorldwide- ...information about AbbVie, please visit us at . Follow @abbvie on X ,Facebook ,Instagram ,YouTube ,LinkedIn and Tik Tok .The Director Regulatory Affairs Global Regulatory Lead (GRL I) in Global Regulatory Strategy is responsible for developing and implementing global...Worldwide
- ...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
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