• Merck & Co. (Rahway, NJ)
    Regulatory Affairs, R&D, Manufacturing and GHH management teams, product development teams, and executive management.Establishes strong cross-functional and ... requirements are met and that systems are used appropriately to ensure proper product control. Ensures appropriate reviews, approvals and systems are in place… more
    HireLifeScience (10/01/25)
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  • Takeda Pharmaceutical (Boston, MA)
    …Therapeutic Area Unit (TAU) portfolio. This is accomplished through leadership of product -specific Global Regulatory Teams (GRTs) and representing the ... Partner with global market access colleagues to Lead interactions with joint regulatory /health agency/HTA bodies on product specific value evidence topics, as… more
    Talent (10/09/25)
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  • Takeda Pharmaceutical (Boston, MA)
    …Therapeutic Area Unit (TAU) portfolio. This is accomplished through leadership of product -specific Global Regulatory Teams (GRTs) and representing the ... with global market access colleagues to lead interactions with joint regulatory /health agency/HTA bodies on product specific value evidence topics,… more
    Talent (10/09/25)
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  • Takeda Pharmaceutical (Boston, MA)
    …with global market access colleagues to Lead interactions with joint regulatory /health agency/HTA bodies on product specific value evidence topics, ... as applicable.Monitor and anticipate trends that impact both the regulatory and access environments to strengthen product development plan(s) and adopt … more
    Talent (10/09/25)
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  • Takeda Pharmaceutical (Boston, MA)
    …of recent in-class approvals .Analyzes relevant competitor labeling and recent product approvals , health authority labeling requests for Takeda products and ... labeling (ie CCDS, USPI and EU SmPC) for regulatory submissions.Ability to review product labeling for...actual base salary offered will be in accordance with state or local minimum wage requirements for the job… more
    Talent (10/09/25)
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  • Takeda Pharmaceutical (Boston, MA)
    …4+ years regulatory and/or related experience.Knowledge of US and EU product labeling regulatory requirements and guidelines. Familiarity with US and/or EU ... life-changing therapies to patients worldwide.Join Takeda as Senior Manager, Global Regulatory Labeling Strategy where you will be responsible for the development… more
    Talent (10/09/25)
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  • Insmed Incorporated (NJ)
    …that will provide regulatory CMC (RA CMC) leadership and strategy to achieve regulatory approvals in various countries. As a strategic function, RA CMC is ... device combination product development at various development stages and product lifecycle management.Stay current with regulatory guidelines and industry… more
    HireLifeScience (08/08/25)
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  • AUROBINDO (Dayton, OH)
    …company with a broad portfolio of generic drugs that includes more than 180 product families and 450 individual product packages. Aurobindo markets over 80% of ... products in the world. In past years, Aurobindo has received more ANDA approvals than any of our competitors. Aurobindo is now ranked 2nd among pharmaceutical… more
    HireLifeScience (10/01/25)
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  • Legend Biotech USA, Inc. (Raritan, NJ)
    …the Building and Environment monitoring team to ensure the facility is in a state of control and update / communicate with all teams with any emergencies and ... clean space walkthroughs to ensure GMP compliance.Actively participate in all regulatory and internal audits of the facility.Participate in the hiring, development,… more
    HireLifeScience (09/23/25)
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  • PEAK Technical Staffing USA (Natrona Heights, PA)
    Overview : The Quality Analysis is responsible for product quality planning, evaluation, and control. This role works cross-functionally with internal and external ... stakeholders to ensure that regulatory as well as Quality Management System (QMS) compliance...Contribute to manufacturing/quality expertise to design reviews for new product development, supplier changes, product changes, and/or… more
    Upward (08/12/25)
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  • Product and Regulatory

    CVS Health (Raleigh, NC)
    …every day. **Position Summary** Responsible for researching, analyzing and interpreting state regulatory requirements, developing and drafting state -specific ... Develop, draft, submit and negotiate timely approval of high-quality regulatory filings that comply with state and...regulators. - Provide timely follow-up and response. - Negotiate regulatory objections. - Obtain regulatory approvals more
    CVS Health (10/08/25)
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  • Director, Global Regulatory Labeling…

    Takeda Pharmaceuticals (Boston, MA)
    …recent in-class approvals . + Analyzes relevant competitor labeling and recent product approvals , health authority labeling requests for Takeda products and ... labeling (ie CCDS, USPI and EU SmPC) for regulatory submissions. + Ability to review product ...actual base salary offered will be in accordance with state or local minimum wage requirements for the job… more
    Takeda Pharmaceuticals (10/10/25)
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  • Regulatory and Specifications Analyst

    Lactalis American Group Inc. (Chicago, IL)
    …The role includes SOP creation and maintenance, certification management, ingredient approvals , product formulation guidance, and artwork review. Additionally, ... include: Labeling & Documentation + Develop ingredient statements, nutrition information, and product specifications to meet FDA, state , customer, and company… more
    Lactalis American Group Inc. (10/10/25)
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  • Regulatory Affairs Director

    Medtronic (Lafayette, CO)
    …office. Relocation assistance is available for qualifying candidates. **Responsibilities** ** Regulatory Strategy & Product Development:** Develop and implement ... global regulatory strategies to support the entire product lifecycle, from R&D through to commercialization and post-market activities. Partner with R&D,… more
    Medtronic (10/03/25)
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  • Principal Regulatory Affairs Specialist…

    Medtronic (Mounds View, MN)
    …**Principal Regulatory Affairs Specialist** will provide strategic leadership for regulatory affairs in support of new product development and introduction ... as they arise. **Role and Responsibilities** + Develop and execute global regulatory strategies for new product development and introduction, including… more
    Medtronic (10/04/25)
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  • Senior Principal, Regulatory Affairs…

    Danaher Corporation (Boston, MA)
    …Files, STED), including documentation, timelines, and agency interactions to secure product approvals . + Collaborate cross-functionally and globally with ... on key projects, engaging with global regulatory agencies, and steering regulatory strategy for new product development and strategic initiatives. By guiding… more
    Danaher Corporation (10/07/25)
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  • Principal Regulatory Affairs Specialist

    Medtronic (Lafayette, CO)
    …**Key Responsibilities:** + Provide strategic input and technical guidance on regulatory requirements for new technologies and product modifications, considering ... approvals , license renewals, and annual domestic and international product registrations. + Recommends changes to labeling, manufacturing processes, marketing… more
    Medtronic (10/04/25)
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  • Regulatory Affairs Associate Director, IVD

    GRAIL (MD)
    …with Quality, Lab Operations, and other stakeholders to support regulatory strategy development, product validation, audits, promotional material ... member of the Regulatory team, offering insights and solutions on corporate product portfolios and strategies. + Provide regulatory support for both new and… more
    GRAIL (10/08/25)
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  • Regulatory Affairs Specialist II

    Fujifilm (College Station, TX)
    …manage the generation of documentation to be submitted to worldwide governmental regulatory agencies to secure approvals for marketing products manufactured ... as applicable. + Provide continuing regulatory education and disseminate regulatory information to the product development, marketing, and clinical groups.… more
    Fujifilm (10/08/25)
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  • Regulatory Affairs Specialist - Abiomed,…

    J&J Family of Companies (Danvers, MA)
    … partners in preparing submissions for global expansion. + Assist in obtaining product approvals and monitor the progress of submissions. + Maintenance of ... recovery. **You will be responsible for** : + Prepare and submit regulatory documents, including applications for product registrations, amendments, annual… more
    J&J Family of Companies (10/01/25)
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