• Associate Director , Global…

    Daiichi Sankyo Inc. (Basking Ridge, NJ)
    …around rare diseases and immune disorders. Summary This position serves as the GRA labeling expert to the Global Regulatory Team (GRT) and independently provides ... strategic and operational leadership on product labeling in collaboration with Global Regulatory Leads (GRLs). This position may serve as an ad hoc member of… more
    Daiichi Sankyo Inc. (10/19/24)
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  • Associate Director , Global…

    Takeda Pharmaceuticals (Columbus, OH)
    …possible in order to bring life-changing therapies to patients worldwide. Join Takeda as Associate Director , Global Labeling Lead where you will be ... of labeling documentation and assures that Takeda labeling content and processes conform to regulatory ...Takeda labeling content and processes conform to regulatory requirements. Management of Local Exceptions and LOC Interactions… more
    Takeda Pharmaceuticals (10/16/24)
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  • Associate Director , Advertising…

    Merck (North Wales, PA)
    …/Senior Director in the Office of Promotion and Advertising Review (OPAR) The Associate Director is responsible for the review and approval of all US ... review divisions Office of Promotion and Advertising Review(OPDP)/Advertising and promotional labeling branch (APLB), including complex regulatory questions and… more
    Merck (10/31/24)
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  • Associate Director

    Bausch Health (Bridgewater, NJ)
    …your skills and values drive our collective progress and impact. The Associate Director , Advertising and Promotion, Prescription Drug Products, reviews, approves ... and monitors prescription drug product advertising and promotional labeling pieces for compliance with regulatory agency requirements. Responsibilities **:** +… more
    Bausch Health (09/24/24)
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  • Associate Director Regulatory

    Abbott (Alameda, CA)
    …work for diversity, working mothers, female executives, and scientists. **The Opportunity** This ** Associate Director Regulatory Affairs - APAC** will work ... Diabetes Division. As a manager, the function of an Associate Director Regulatory Affairs, APAC...preclinical, clinical and manufacturing charges. + Review and approve labeling to ensure compliance. + Represent regulatory more
    Abbott (08/28/24)
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  • Associate Director

    Abbott (Alameda, CA)
    …work for diversity, working mothers, female executives, and scientists. **The Opportunity** This ** Associate Director Regulatory Affairs - US New Product ... levels in one sensor. The role will also include responsibilities for regulatory support for on-market change management and manufacturing sites. The individual has… more
    Abbott (10/02/24)
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  • Associate Director , US Advertising…

    Takeda Pharmaceuticals (Lexington, MA)
    …the best of my knowledge. **Job Description** Join Takeda as an Associate Director , US Advertising & Promotion Regulatory Review out of our Lexington, MA or ... and regulations for development of marketing materials, including representation on global regulatory and labeling teams. + Provide leadership related to issues… more
    Takeda Pharmaceuticals (09/06/24)
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  • Associate Director

    Gilead Sciences, Inc. (Foster City, CA)
    …and operational regulatory guidance on new concepts, campaigns, and product labeling for the assigned brands. You may manage complex interactions related to ... Project Team meetings. + Represents RA Ad/Promo at labeling meetings and provides strategic regulatory guidance....Ad/Promo at labeling meetings and provides strategic regulatory guidance. + Mentors RA Ad/Promo and cross-functional team… more
    Gilead Sciences, Inc. (10/01/24)
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  • Director , Global Regulatory Affairs…

    Merck (Boston, MA)
    …obtain shortest time to approval by global regulatory agencies. + Reports to Associate Vice President, Executive Director , or Senior Director in the ... **Job Description** We are seeking a Director (Principal Scientist), Global Regulatory Affairs...regulatory oversight for assigned products, to optimize product labeling and… more
    Merck (10/31/24)
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  • Senior Principal Scientist (Senior Director

    Merck (Boston, MA)
    **Job Description** We are seeking a Senior Director (Sr. Principal Scientist) Global Regulatory Affairs Liaison with a visionary, growth-oriented mindset that ... regulatory oversight for assigned products, to optimize product labeling and obtain shortest time to approval by global...external to GRACS. **Key Functions** + Reports to Executive Director or Associate Vice President, General Medicine… more
    Merck (10/31/24)
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  • Associate Director , Patient…

    AbbVie (Mettawa, IL)
    …with HEOR Strategy and other functions (eg, Clinical Development & Operations, Regulatory , Commercial). The Associate Director , Patient-Centered Outcomes ... key opinion leaders, research organizations, patient advocacy groups). The Associate Director represents HEOR at global regulatory and payer / HTA meetings… more
    AbbVie (10/30/24)
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  • Associate Director , Safety…

    BeiGene (Emeryville, CA)
    **General Description:** _The Associate Director , Safety Scientist supports assigned compounds in conjunction with Product Safety Leads (PSLs) and leverages ... in departmental activities **Supervisory Responsibilities:** This position has no direct reports. The Associate Director , Safety Scientist is part of a team that… more
    BeiGene (10/21/24)
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  • Associate Medical Director

    Takeda Pharmaceuticals (Cambridge, MA)
    …that will inspire you and empower you to shine? Join us as an Associate Medical Director Neurodegenerative Disorders in our Neuroscience Therapeutic Area Unit in ... a vital contributor to our inspiring, bold mission. ​ **​POSITION OBJECTIVES:** ​The Associate Medical Director leads and drives strategy for clinical studies… more
    Takeda Pharmaceuticals (09/25/24)
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  • Associate Director - QA Packaging

    Lilly (Durham, NC)
    …people who are determined to make life better for people around the world. Associate Director - Quality Assurance (QA) Packaging is responsible for the staffing, ... and Packaging (DAP) production area at Lilly RTP. The Associate Director will help build a strong...and ensure compliance with area procedures and controls for labeling and packaging operations + Foster a strong quality… more
    Lilly (09/24/24)
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  • Associate Director , Clinical…

    AbbVie (Irvine, CA)
    …Translational Pharmacokinetics and Clinical Pharmacology group at AbbVie is seeking for an Associate Director . As a member of multidisciplinary teams, this role ... engagement strategy for assets in eyecare, aesthetics, and neurotoxin portfolios. The Associate Director of Clinical Pharmacology will also establish innovative… more
    AbbVie (09/27/24)
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  • Associate Federal Regulatory Affairs…

    American Heart Association (Washington, DC)
    …career. The **American Heart Association** has a phenomenal opportunity for an ** Associate ** ** Regulatory Affairs Manager** with our Federal Advocacy Team in ... (hybrid work arrangements available. Under the direction of the Director , Federal Regulatory Affairs, you would be...of Agriculture (USDA). Core topics would include nutrition, food labeling , and prevention, with the opportunity to assist on… more
    American Heart Association (10/02/24)
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  • Senior Scientist / Associate

    Daiichi Sankyo Inc. (Basking Ridge, NJ)
    …working with contract manufacturing organizations CMO.** This position serves as the Regulatory Affairs (RA) CMC project representative to the CMC sub team and ... applications/supplements & variations (eg, NDA, BLA, MAA). This position authors regulatory documents where necessary with supervision. This position conducts … more
    Daiichi Sankyo Inc. (08/22/24)
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  • Associate Director , Project…

    Abbott (Alameda, CA)
    …way patients and professionals measure, track and analyze glucose levels. As an Associate Director , project leadership, you will be responsible for Managing one ... budget and on strategy. These activities include coordination of artwork and labeling , in-house and third-party manufacturing, inventory phase in and phase out,… more
    Abbott (08/15/24)
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  • Associate Director , Clinical Supply…

    Merck (Rahway, NJ)
    …portfolio of clinical trials. GCS is accountable for the planning, sourcing, labeling , packaging and delivery of clinical supplies to clinical sites globally. The ... a lead GCS Planning program representative) such as clinical development, regulatory , quality and other supply chain areas to negotiate timelines, strategies… more
    Merck (10/12/24)
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  • Associate Medical/Medical Director

    ThermoFisher Scientific (Wilmington, NC)
    …trials to ensure company SOPs, client directives, good clinical practice, and regulatory requirements are followed. Attends and presents at investigator and sponsor ... ( eg PBRER, PSUR, DSUR) as well as other client deliverables (eg labeling reconciliation documents, CTD modules, REMS, RMP and CSR) **Essential Functions:** Manages… more
    ThermoFisher Scientific (10/30/24)
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