Regulatory Affairs Director - Radiopharma Strategy
ARTBIO, Inc.
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, high-quality submissions. The position works cross-functionally with Clinical, CMC, Quality, and Operations to maintain an aligned submission narrative, and to ensure timely INDs, amendments, and lifecycle submissions. #J-18808-Ljbffr ARTBIO, Inc.
- 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...Suggested
- 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...SuggestedWork at office3 days per week
$232k - $348k
Job DescriptionThe Regulatory Strategy Senior Director is a regulatory leader with expert technical and tactical experience in regulatory strategy for... ...senior management on status of global Regulatory Affairs strategies and tactics, procedures and practicesLeads the...SuggestedFull 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... .... Director will be a strategic leader within Regulatory Affairs, responsible for developing and executing regulatory...SuggestedPermanent 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... ..., risks, mitigations and overall plans to Regulatory Affairs the Project Team and senior management, as relevant.May be...SuggestedPermanent employmentFull timeWork at officeWork from home$177k - $278.08k
...changing therapies to patients worldwide.Join Takeda as Director, Global Regulatory Labeling Strategy where you will be responsible for the development and... ...functional teams, including clinical, safety, medical affairs, and commercial, to ensure unparalleled communication...Minimum wageLocal areaRemote workWorldwide$268.2k - $402.2k
Job DescriptionGeneral Summary:The Executive Director, Regulatory Strategy will serve as a seasoned regulatory leader with expert technical and tactical... ...advises senior management on status of global Regulatory Affairs strategies and tactics, procedures and practicesCreates...Full timeSummer workLocal areaRemote workFlexible hours2 days per week$200k - $265k
...unparalleled, direct impact.The OpportunityLeads the global regulatory strategy, submission planning, and health authority engagement for Nemolizumab... ...and agreed timelines. Accountable for the Global Regulatory Affairs team supporting nemolizumab and for driving successful...Full timeTemporary workWork experience placementWork at officeWorldwide$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- ...Vertex Pharmaceuticals LLC is seeking a Director of Regulatory Affairs CMC in Boston. The role leads a Regulatory CMC team, shaping global strategies for small molecule programs and coordinating Health Authority interactions across development and commercialization....
- ...customers in regulated industries Manage External & Internal Audits: Serve as the primary point of contact for customer audits, regulatory body inspections, and internal quality assessments. Act as a Strategic Advisor: Partner with engineering, product, customer...Full timeWork at officeFlexible hours
- ...Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok. Job Description The Director Regulatory Affairs Global Regulatory Lead (GRL II) Global Regulatory Strategy is responsible for developing and implementing global strategies to secure and maintain...Temporary workWorldwide
- 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...
- AstraZeneca plc in Cambridge, MA, invites you to shape regulatory strategy across development, commercialization and life cycle management.... ...collaboration across global, regional, and local regulatory affairs, coaching staff, and staying ahead of evolving laws. #J-188...Local area
- 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...
- 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...
- 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...
- 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
- AstraZeneca seeks a seasoned Regulatory Leader to guide strategic regulatory activities across development, launch... ...with global teams to shape regulatory strategies and compliance. With 6+ years in regulatory affairs, you will oversee risk assessments, provide coaching...Local area
- ...Executive Director, Regulatory Strategy About the Company Clinical-stage biopharmaceutical company developing innovative, transformational... ...the company should have a proven track record in regulatory affairs, with a focus on clinical-stage assets. The role requires...
$186.23k - $279.35k
...will:Provide strategic and operational regulatory leadership to the development, commercialization... ...regulatory requirements and strategies. Influence Regulatory authorities through... ...the global, regional and local Regulatory Affairs interface enabling rapid andeffective submissions...Full timeTemporary workWork at officeLocal areaWorldwideFlexible hours3 days per week- 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 job
- ...follow @ScholarRock on X and on LinkedIn. Summary of Position: The Vice President, Head of Regulatory Strategy, reporting to the SVP, Global Head of Regulatory Affairs, is accountable for building and leading the Global Regulatory Strategy team, responsible for...Work at officeLocal areaShift work
$170k - $215k
..., and New York City with 250+ employees world-wide.As Director of Site Performance & Strategy- Cardiology at Iterative Health, you will lead the strategy... ...centralized site solutions—including pre-screening, regulatory support, and eSource—you will partner cross-...Temporary workWork at office2 days per week$109k - $142k
...blend a technical foundation with proven project management or strategy expertise to effectively coordinate complex, cross-functional... ...directed to shareholders, executive leadership, and the Board of Directors.Information Synthesis: Digest complex technical, financial,...Work at officeMonday to Thursday- Smithsonian Astrophysical Observatory in Cambridge, MA, seeks a Director of Human Resources to lead HR strategy, modernization, and compliance onsite. You will manage Federal and non-Federal (Trust) hiring, immigration programs, and HR analytics across SAO sites, advancing...
- 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...
$166.35k - $195.7k
...Lead the high net worth CX program end-to-end, defining segment strategy, retention priorities, the service model, and the cross-... ...prioritization frameworks for ambiguous, high-stakes problems, influencing Director+ stakeholders to align on tradeoffs, resources, and sequencing...Local area$160k - $185k
...world?Learn more about our unique culture and history.Job Opportunity: BHSI is seeking an experienced and forward-thinking Director, Strategy & Planning, to lead Technology Vendor Strategy across our global technology organization. This role will build a disciplined,...Contract workTemporary workFlexible hours
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Regulatory Affairs Director - Radiopharma Strategy. Be the first to apply!
- regulatory manager Cambridge, MA
- regulatory affairs manager pharmaceutical Cambridge, MA
- director global regulatory affairs Cambridge, MA
- corporate compliance manager 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




