• Associate Director, Regulatory Data…

    Takeda Pharmaceuticals (Boston, MA)
    …and oversight of data related to the drug development lifecycle, including regulatory submissions , labeling, and product tracking; Oversee Regulatory ... opportunity: **JOB LOCATION:** Cambridge, MA **POSITION** : Associate Director, Regulatory Data Governance Lead **POSITION DESCRIPTION** : Takeda Development Center… more
    Takeda Pharmaceuticals (05/31/25)
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  • Regulatory Coordinator - Gynecologic…

    Dana-Farber Cancer Institute (Brookline, MA)
    …GYN Oncology clinical research project. The RC coordinates aspects of protocol submissions , prepares and submits regulatory documents, and maintains records on ... and consent design and development and FDA IND and other regulatory required submissions **KNOWLEDGE, SKILLS, AND ABILITIES REQUIRED:** + Must possess excellent… more
    Dana-Farber Cancer Institute (07/23/25)
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  • Regulatory Affairs Innovation Lead - VIE…

    Sanofi Group (Cambridge, MA)
    …Strategic Foresight techniques would be a strong advantage. + Familiarity with regulatory processes, submissions , and health authority interactions is preferred. ... ** Regulatory Affairs Innovation Lead - VIE Contract** +..._As_ **_Regulatory Affairs Innovation Lead VIE_** _within our Global Regulatory Operations team, you'll be at the forefront of… more
    Sanofi Group (07/18/25)
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  • Associate Director, Global Regulatory…

    Sanofi Group (Cambridge, MA)
    …of patient experience data to maximize labeling value. + Assist in labeling submissions , regulatory queries, and updates to ensure compliance with regulatory ... **Job Title:** Associate Director, Global Regulatory Affairs - Global Labeling Strategy **Location** :...helping our teams accelerate progress. The Associate Director, Global Regulatory Affairs - Global Labeling Strategy is responsible for… more
    Sanofi Group (06/27/25)
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  • Principal Reg Affairs Specialist

    Medtronic (Boston, MA)
    …and related regulatory standards. Proven experience in global regulatory submissions and product approvals. Excellent communication and leadership ... + Directs or performs coordination and preparation of document packages for regulatory submissions from all areas of company, internal audits and inspections. +… more
    Medtronic (07/30/25)
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  • Principal RA Associate Devices

    Fresenius Medical Center (Waltham, MA)
    …SCOPE:** Develops regulatory strategies for assigned products/product lines. Prepares regulatory submissions required to market new or modified medical ... requirements to product development teams. + Develops strategies for submissions to FDA and other regulatory agencies....strategies for submissions to FDA and other regulatory agencies. Provides regulatory risk assessments and… more
    Fresenius Medical Center (06/14/25)
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  • Auditing & Compliance Director - Software as…

    Wolters Kluwer (Waltham, MA)
    …renewals, new product registrations, and product change registrations. + Ensure regulatory submissions are well-organized, scientifically accurate, high quality, ... develop internal SOPs, WIs, and policies. + Continuously pursue regulatory knowledge to gain expertise in product submissions... regulatory knowledge to gain expertise in product submissions and regulatory topics. + Coach and… more
    Wolters Kluwer (06/11/25)
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  • Associate Director, Regulatory Affairs

    Rhythm Pharmaceuticals (Boston, MA)
    …standards and commitments + Lead the planning and authoring of content for submissions to Regulatory Agencies (eg, INDs, CTAs, meeting requests, briefing ... to overcome barriers, together. Opportunity Overview In the Associate Director, Regulatory Affairs role, you will be responsible for ensuring the development… more
    Rhythm Pharmaceuticals (06/18/25)
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  • Associate Director, Biostatistics

    Pfizer (Cambridge, MA)
    …publishing manuscripts through co-authorship. The candidate may also provide support in regulatory submissions including responses to regulatory queries. ... + Provide scientifically rigorous statistical input into project development plans, regulatory submissions , interpretation of statistical results, study design,… more
    Pfizer (06/14/25)
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  • Senior Principal Scientist, Lead Development…

    Bristol Myers Squibb (Cambridge, MA)
    …and translational data generated to support asset development and contribute to regulatory submissions . This individual will work on cross-functional project ... written documents such as primary manuscripts/publications/reviews, scientific presentations and regulatory submissions (INDs/NDAs) with ability to synthesize… more
    Bristol Myers Squibb (06/01/25)
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