Regulatory Strategy Director Radiopharmaceuticals
Artbio
ARTBIO, a pioneering biotech company, seeks a Senior Director of Regulatory Affairs to lead regulatory interactions for clinical-stage radiopharmaceutical programs. You will coordinate medical writing, ensure compliant submissions, and partner with Clinical, Medical, CMC, Quality, and other teams to craft a cohesive regulatory narrative. You will drive INDs, annual reports, and lifecycle submissions, while establishing submission plans, timelines, and archives. #J-18808-Ljbffr
- ...ARTBIO seeks a Senior Director, Regulatory Affairs to lead regulatory interactions and submission execution for our clinical-stage radiopharmaceutical programs. This role coordinates regulatory medical writing across functions to translate research data into compliant...Suggested
- ...Scholar Rock is seeking an Associate Director, Regulatory Strategy, to lead development and execution of regulatory plans for clinical and pipeline programs. You will represent regulatory affairs in program teams, highlighting risks and opportunities to inform strategy...Suggested
- ...AstraZeneca seeks a seasoned Regulatory Leader to guide strategic regulatory activities across development, launch, and lifecycle for... ...authorities and collaborate with global teams to shape regulatory strategies and compliance. With 6+ years in regulatory affairs, you will...SuggestedLocal area
- ...AstraZeneca plc in Cambridge, MA, invites you to shape regulatory strategy across development, commercialization and life cycle management. You will lead regulatory planning, coordinate with product teams, and influence authorities to secure timely approvals while ensuring...SuggestedLocal 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...Suggested
- 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...
- 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. You...
- 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...
- ...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...
- ...Alexion, part of AstraZeneca’s Rare Disease unit in Boston, seeks a Director of Regulatory Affairs US to drive regulatory strategies for complex products and lead US submissions. You will coordinate with FDA and Global Regulatory teams to align on strategy, timelines,...
- ...A leading pharmaceutical company is looking for a Director of Regulatory Affairs to provide strategic and operational leadership in developing and commercializing products. The candidate will prepare regulatory submissions, interact with health authorities like the FDA...
- ARTBIO seeks a Senior Director, Regulatory Affairs to lead regulatory interactions and submissions across clinical-stage radiopharmaceutical programs. You will coordinate medical writing and translate R&D data into compliant regulatory communications, guiding high-quality...
- 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
$177k - $278.08k
...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 of...Minimum wageLocal areaRemote workWorldwide$232k - $348k
Job DescriptionThe Regulatory Strategy Senior Director is a regulatory leader with expert technical and tactical experience in regulatory strategy for the assigned global or regional position and will be responsible for overseeing the development and implementation of advanced...Full timeSummer workWork at officeLocal areaRemote workFlexible hours2 days per week3 days per week$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. This is a newly created role intended for a forward looking, creative regulatory strategist able to anticipate and address...Permanent employmentFull timeWork at officeWork from home$196.7k - $353.4k
The Role:Moderna, Inc. is seeking a Sr. Director of Regulatory Strategy to lead Regulatory Strategy programs to be based in its Cambridge headquarters or one of Moderna’s East Coast hubs. This role is intended for a forward looking, creative regulatory strategist able to...Permanent employmentFull timeWork at officeWork from home$268.2k - $402.2k
Job DescriptionGeneral Summary:The Executive Director, Regulatory Strategy will serve as a seasoned regulatory leader with expert technical and tactical regulatory knowledge and advanced drug development expertise in Type 1 Diabetes (T1D). The incumbent will be responsible...Full timeSummer workLocal areaRemote workFlexible hours2 days per week$200k - $265k
...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 indications,...Full timeTemporary workWork experience placementWork at officeWorldwide- ...Copenhagen, Denmark Reporting to : VP, Regulatory Affairs & Quality About Hemab Hemab... ...and Copenhagen, Denmark. The role As Director, Regulatory Affairs, you'll shape and deliver global regulatory strategy for Hemab's development programs in rare bleeding...Remote work
$182k - $346k
...Follow @abbvie on LinkedIn, Facebook , Instagram , X and YouTube. Job Description The Director Regulatory Affairs Global Regulatory Lead (GRL II), Global Regulatory Strategy (Neuroscience), is responsible for developing and implementing global strategies to secure...Worldwide- ...Hemab Therapeutics in Cambridge, MA is seeking a Director, Regulatory Affairs to shape and deliver global regulatory strategy for our rare bleeding disorder programs. You will sit close to science and development teams, turning complex data into clear regulatory choices...Remote work
- ...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
$151k - $222.1k
...our systems, to the charge a merchant sees. We are part of Sales Strategy & Operations, which builds the go-to-market strategies,... ...Legal, and Internal and External Audit. You will report to the Director, Sales Compliance. [Work model — e.g., hybrid, with some time in...Hourly payContract workWork at officeLocal areaRemote workFlexible hours$155k - $410k
...SectorHealth ServicesSpecialismCorporate and Business StrategyManagement LevelDirectorJob Description & SummaryThe OpportunityAs a Strategy Consulting Director within our Strategy practice, you will provide strategic guidance and insights to organizations, analyzing market trends...Full timeH1b- ...Vertex Pharmaceuticals Inc is seeking a Strategy & Operations Director to support the Disease Strategy Team in the Office of the CEO. You will partner with a Disease Area Executive to drive strategic initiatives, develop KPI dashboards, and craft high-impact executive...Work at office
- ...Mass General Brigham Health Plan Holding Company, Inc. is seeking a capable project/program manager to support MassHealth regulatory reporting and governance activities. The role involves coordinating cross-department processes, maintaining calendars and documentation...Remote work
$230k - $250k
...Director, Global Regulatory Affairs - Strategy Lead Olema Oncology is a clinical-stage biopharmaceutical company committed to transforming the standard of care and improving outcomes for patients living with breast cancer and beyond. With our transformation into a...Work at officeFlexible hours2 days per week- Spryte Medical seeks a Director of Regulatory Affairs to guide global regulatory strategy for a portfolio of neurovascular imaging devices. You will lead cross‑functional teams, manage complex submissions, and oversee external regulators to accelerate market access. The...
- Takeda is seeking a Director to lead the strategy, design, and execution of programs that build and sustain critical regulatory capabilities globally. You will capture, organize, share, and apply regulatory knowledge across the organization while aligning with HR, learning...
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Regulatory Strategy Director Radiopharmaceuticals. Be the first to apply!
- regulatory manager Cambridge, MA
- regulatory affairs manager pharmaceutical Cambridge, MA
- director global regulatory affairs Cambridge, MA
- regulatory cmc manager Cambridge, MA
- regulatory & compliance manager Cambridge, MA
- compliance manager Cambridge, MA
- regulatory affairs manager medical devices Cambridge, MA
- regulatory affairs director Cambridge, MA
- compliance director Cambridge, MA
- training and compliance manager Cambridge, MA


