Senior Regulatory Affairs Lead — Global Strategy & Lifecycle
$193k - $210kKatalyst CRO
A pharmaceutical firm in Cambridge, MA seeks a Senior Regulatory Affairs Manager to lead the development and execution of regulatory strategies throughout the product lifecycle. Candidates should hold a PhD in health or life sciences, with 6+ years of relevant experience. Responsibilities include ensuring alignment with clinical plans and incorporating global Health Authority feedback. This role offers a competitive salary between $193,000 and $210,000. #J-18808-Ljbffr Katalyst CRO
$178.1k - $244.86k
...development and advancement of Global Patient Access (GPA) strategies across programs, ensuring... ...with enterprise priorities, regulatory requirements, and product lifecycle needsDrive data-driven and technology... ...globallyACCOUNTABILITIES Lead end-to-end strategy...SeniorMinimum wageTemporary workLocal areaNight shift$212k - $333.19k
...patients worldwide.Join Takeda as a Senior Director, Global Regulatory Lead - Oncology, where you will be part... ...challenges and ideas into actionable strategies. You will set global regulatory... ...understanding broad concepts within regulatory affairs and implications across the...SeniorMinimum wageTemporary workLocal areaRemote workWorldwide- Senior Director, Global Regulatory Lead, GI & Inflammation About the role: The Global Regulatory Leads, Senior... ...programs Implement compliance strategies and processes Prepare, review, and... ...skills and knowledge in regulatory affairs Strong strategic planner with a proven...SeniorFull timeLocal area
- ...Facebook, Instagram, X and YouTube. Job Description The Senior Manager, Regulatory Affairs US & Canada Strategy Lead - Therapeutic Neurotoxins is responsible for the... ...a Therapeutic Area and supports manager and/or Global Regulatory Lead (GRL) in the development &...SeniorLocal area
- ...in the United States seeks a Global Brand Lead to shape and deliver the global brand strategy for an asset portfolio, aligning... ...for launch readiness and lifecycle growth. The role demands strategic... ...across Medical, Market Access, Regulatory, and Supply Chain functions....Suggested
- Senior Director, Program Leader, Corporate Strategy At Agios, we are fueled by connections... ...through regulatory approval, launch, and lifecycle management,... ...fully integrated global asset strategy... ...mitigation strategies. Lead asset... ...with Regulatory Affairs to guide global...Senior3 days per week
- Katalyst CRO in Boston is seeking a Regulatory Affairs professional to lead CMC strategies for investigational products. The candidate will interact with Health Authorities and manage regulatory submissions to ensure compliance and success. With a foundation in regulatory...Senior
- A leading life sciences company is seeking a Senior Regulatory Affairs Manager to lead their dynamic team through global clinical trials. The role involves driving submission planning, ensuring compliance with regulatory authorities, and managing multiple priorities. Candidates...SeniorRemote job
- AbbVie is seeking a Director Regulatory Affairs Global Regulatory Lead (GRL II) in Cambridge, MA. This role entails developing and implementing global strategies for product approvals while leading the Global Regulatory Product Team (GRPT). The ideal candidate will possess...
$211.5k - $258.5k
Job Summary The Director, Regulatory Strategy - Global Regulatory Lead is responsible for developing and leading the... ...As a key member of the Regulatory Affairs team, this individual also contributes... ...informed and involving senior management at key decision points....Local areaFlexible hours2 days per week- ...: This role is within the Global Regulatory Affairs (GRA) Chemistry Manufacturing... ...: With some supervision, leads the execution of regulatory... ...registration and/or post-approval strategies for assigned products. RA... ...development and commercial lifecycle. Has a strong foundational...Senior
- ...AstraZeneca is looking for a Global Safety Program Lead, Senior Director in Boston, MA. This role requires extensive leadership in safety strategy, managing a team of safety physicians and scientists while ensuring compliance with regulations. The ideal candidate should...Senior
$100k - $143k
Relaytherapeutics in Cambridge, Massachusetts is looking for a motivated regulatory professional to join their regulatory team. In this role, you will support the development and execution of regulatory strategies for a transformative pipeline, contributing to IND, CTA, NDA,...- ...Therapeutics seeks a Global Competitive Intelligence Lead - Oncology to... ...execute the oncology CI strategy across all programs... ...launches and lifecycle management. The role... ...collaborating with Medical Affairs, Market Access, and... ...insights to senior leadership. #J-188...
- Alnylam Pharmaceuticals is seeking an Associate Director of Regulatory Affairs Strategy in Cambridge, Massachusetts. The role involves leading regulatory strategy for CNS programs and facilitating timely submission of regulatory documents to the US. Applicants should have...
- Moderna is seeking an Associate Director, Global Regulatory Advertising and Promotion to ensure compliance for promotional materials across channels. You will liaise with Regulatory Affairs, Legal, Medical, and Commercial teams to guide advertising and promotional activities...
- Biogen seeks a strategic CMC Asset Lead within the PO&T Nephrology team to oversee asset strategy, launch planning, and lifecycle management for a high-priority nephrology asset slated... ...governance boards, with a track record in global matrix environments and strong financial...
- ...Biopharmaceuticals Inc. seeks a VP, Global Asset Lead in Cambridge, MA. The role... ...development through launch and lifecycle management, partnering with senior executives across functions to maximize... ...team, shaping development strategies, optimizing resources, and ensuring...
- Ipsen seeks a Global Brand Lead to shape and deliver the integrated global brand strategy for a specified asset, coordinating launch readiness and lifecycle growth across regions. You will lead cross-functional... ..., Medical, Market Access, Regulatory, and more, translating...
- Job title : Global Lead, Scientific Platforms & Engagement Strategy Location: Cambridge,... ...results clearly to senior leadership,... ...generated content meet regulatory, MLR review, and... ...experience in Medical Affairs, Scientific... ...full innovation lifecycle from scouting through...
- Noema Pharma in Watertown, MA is seeking a Director of Regulatory Affairs to lead regulatory strategy and oversight for multiple development programs, from IND through potential NDA/MAA submissions, and to guide cross-functional teams toward compliant execution. The ideal...
$177k - $308k
...around the world. We are a global healthcare leader... ...using its innovation-based strategy to discover, develop... ...& Technology Strategy Lead who will define and implement... ...scientific rigor, regulatory defensibility, and meaningful... ...Statistics, Regulatory Affairs) to ensure seamless AI...SeniorFull timeFlexible hours- Beeline Medicines is seeking a Senior Director, Regulatory Affairs CMC - Biologics to lead regulatory science for biologics assets across the development lifecycle. You will drive global CMC strategy, author submissions, and coordinate with Process Development, Analytical...Senior
- ...Alexion Pharmaceuticals, Inc. is seeking a Global Safety Program Lead, Senior Director in Boston, MA. You will own the safety strategy and delivery for assigned assets, lead a... ...high-quality safety deliverables and regulatory compliance. The role requires medical or...Senior
$212k - $333.19k
...empower you to shine? Join us as a Senior Director, Global Program Lead- Neuroscience in our Cambridge, MA... ...Program(s). The GPL defines the asset strategy and leads all development and LCM... ...leadersCommitted to simultaneously driving regulatory approval as well as launch and...SeniorMinimum wageTemporary workWork at officeLocal areaRemote work- Acrivon Therapeutics, Inc. in Watertown, Massachusetts is seeking a Vice President or Senior Vice President of Regulatory Affairs. This role leads global regulatory strategies for the oncology pipeline and ensures compliance with regulatory requirements. The ideal candidate...
- Amrize seeks a Senior HME & Auxiliary Fleet Manager to develop and execute the enterprise fleet strategy for Heavy Mobile Equipment, Off-Road and Auxiliary Fleet across North America. You will lead fleet planning, lifecycle management, capital forecasting, and standardized...Senior
- A leading financial services firm is seeking a Senior/Manager in Compensation to support competitive compensation program designs across the organization. This role requires establishing data-informed pay decisions and partnering with HR, Finance, and business leaders....Senior
- SharkNinja in Needham, MA seeks a Senior Manager to shape talent partnership strategy and activation, driving strategic frameworks and data-backed performance across global and regional programs. You will partner with analytics, social, and commercial teams to translate...SeniorContract work
$137k - $215.27k
...worldwide.This role is within the Global Regulatory Affairs (GRA) Chemistry... ...follows: With some supervision, leads the execution of regulatory... ...registration and/or post-approval strategies for assigned products.RA... ...development and commercial lifecycle.Has a strong foundational...SeniorMinimum wageTemporary workLocal areaRemote workWorldwide
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