• Insmed Incorporated (San Diego, CA)
    …Workplaces for Women™, Best Workplaces for Millennials™, and Best Medium Workplaces™ lists.OverviewThe Director , Regulatory Affairs will serve as the ... teamsWith oversight from the VP of Regulatory Affairs , lead the development and implementation of global... Affairs , lead the development and implementation of global regulatory strategy plans to facilitate efficient… more
    HireLifeScience (08/13/25)
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  • Daiichi Sankyo, Inc. (Bernards, NJ)
    …research areas centered around rare diseases and immune disorders. Summary The Associate Director , Global Oncology Medical Affairs , Medical Analytics will be ... Affairs Impact and Omnichannel strategy. This is a global role which will work across regions, functions and...of related experience working in data analytics in commercial, regulatory , market access or medical affairs function… more
    HireLifeScience (09/26/25)
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  • Daiichi Sankyo, Inc. (Bernards, NJ)
    …for continuous quality improvement.Deputize for the Sr. Director , Medical Affairs QA as needed. Cross-functional and Global Team Participation:Drive quality ... and immune disorders. Job Summary: Reporting to the Sr. Director , Medical Affairs QA, the Director...or clinical development. requiredMust possess a solid understanding of global health authority regulatory requirements particularly in… more
    HireLifeScience (09/03/25)
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  • Lundbeck (North Hyde, SD)
    Lundbeck Australia is currently seeking a highly motivated and experienced Regulatory Affairs Manager to lead and manage regulatory activities across our ... regulatory submissions, maintaining licences and liaising with government authorities.The Regulatory Affairs Manager plays a critical part in ensuring… more
    HireLifeScience (09/25/25)
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  • Merck & Co. (Rahway, NJ)
    …Leadership Team.-This Lead plays a critical role in driving alignment and execution globally across Global Regulatory Affairs CMC ( Global Regulatory ... MAA) and limited CMC post-approval-changes.Leverage industry and agency connections in partnership with Regulatory Affairs Global Regulatory Policy and… more
    HireLifeScience (10/01/25)
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  • Daiichi Sankyo, Inc. (Bernards, NJ)
    …timely deployment of CDx assays that are compliant with applicable global regulatory guidelines. Collaborates wtih Regulatory Affairs to develop CDx ... diseases, under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi...trials or for approval of CDx. Keeps abreast of regulatory and policy updates in the external environment and… more
    HireLifeScience (09/13/25)
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  • Merck & Co. (Millsboro, DE)
    …SOPs, Quality Notifications and technical documentation; collaborate cross-functionally with QA, Regulatory Affairs , EHS, Engineering, BTS, ATS and HR.Direct ... operations, formulation and fill/finish activities.Ensure compliance with corporate and regulatory requirements (cGMP/USDA) and lead IPT support for audits,… more
    HireLifeScience (10/03/25)
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  • Merck & Co. (Upper Gwynedd, PA)
    …--Work closely with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical development ... Job DescriptionOur company is a global health care leader with a diversified portfolio...Medical Research, Mentorship, Plan of Action and Milestones (POA&M), Regulatory Affairs Compliance, Regulatory Compliance… more
    HireLifeScience (09/30/25)
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  • Merck & Co. (Durham, NC)
    …diversity, and effectiveness Regulatory Acumen and effective working relationship with Global Regulatory Affairs and Clinical Safety (GRACS) Demonstrated ... Position Description: Under the direction of the Network Strategy & Execution Director , the Associate Director is responsible for assessing, leading and… more
    HireLifeScience (09/24/25)
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  • Daiichi Sankyo, Inc. (Bernards, NJ)
    …compliance activities and fosters a culture that seeks to constantly enhance global regulatory compliance to meet signal evaluation timelines.Develop quality ... (eg SOPs) as appropriate.Collaborate with cross-functional teams (eg, Medical Safety, Regulatory Affairs , Epidemiology) to ensure benefit-risk integration to… more
    HireLifeScience (09/03/25)
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  • Merck & Co. (North Wales, PA)
    …Medical Affairs , Policy, Payer Marketing, Finance, Manufacturing, L&D, Global Communications, Regulatory , Legal/Compliance Manage agency relationships and ... an active research pipeline.We are currently recruiting for a results-driven and strategic Director , Product Marketing Owner - HCP for HIV. As a key leader within… more
    HireLifeScience (10/01/25)
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  • Insmed Incorporated (San Diego, CA)
    …with the Biometrics teams, Clinical Operations teams, Clinical Development teams, Regulatory Affairs , and external partners.ResponsibilitiesEDC System Design & ... Company DescriptionInsmed is a global biopharmaceutical company on a mission to transform...Workplaces for Millennials™, and Best Medium Workplaces™ lists.OverviewThe Associate Director , EDC Programming will lead and oversee EDC programming,… more
    HireLifeScience (09/10/25)
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  • Eisai, Inc (Nutley, NJ)
    …to the health economics and outcomes research strategies, and timelines with medical affairs , marketing, managed markets and global value and access teams. ... difference. If this is your profile, we want to hear from you. The Director , US HEOR and RWE (field) is responsible for developing HEOR engaging population-based… more
    HireLifeScience (09/09/25)
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  • Director , Global Regulatory

    Sanofi Group (Cambridge, MA)
    **Job Title:** Director , Global Regulatory Affairs - Global Labeling Strategy **Location:** Morristown, NJ Cambridge, MA **About the Job** Are you ... families. Your skills could be critical in helping our teams accelerate progress. The Director , Global Regulatory Affairs - Global Labeling Strategy… more
    Sanofi Group (10/02/25)
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  • Director , Global Regulatory

    Takeda Pharmaceuticals (Boston, MA)
    …what is possible in order to bring life-changing therapies to patients worldwide. The Director Global Regulatory Affairs , Neuroscience is responsible for ... andbuilding appropriate regulatory strategy. + Participates in cross-functionalinitiativeswithin Global Regulatory Affairs and Takeda R&D. **How… more
    Takeda Pharmaceuticals (10/01/25)
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  • Director , Global Regulatory

    Candela Corporation (Marlborough, MA)
    ** Director , Global Regulatory Affairs ** Requisition Number **2872** Location **US - Marlborough, MA** State/Territory **Massachusetts** **Company ... distributors in over 60 other countries. **General Summary** The Director , Global RA will be fully accountable...+ Global accountability to establish/maintain a high-performance Regulatory Affairs team. + Actively support New… more
    Candela Corporation (08/29/25)
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  • Associate Director , Global

    Sanofi Group (Cambridge, MA)
    **Job Title:** Associate Director , Global Regulatory Affairs Advertising and Promotion **Location** : Cambridge, MA Morristown, NJ **About the Job** Are ... thought was possible. Ready to get started?​ **Main Responsibilities:** + Represents Global Regulatory Affairs (US RA AdPromo) as a member of… more
    Sanofi Group (09/30/25)
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  • Senior Advisor/ Director , Global

    Lilly (Indianapolis, IN)
    …patients who need them all over the world. The Senior Advisor/ Director in Global Regulatory Affairs - CMC Pre-approval Small Molecules will leverage CMC ... + Development of regulatory strategy and update strategy based upon global regulatory changes. + Provide regulatory guidance to allow CMC development… more
    Lilly (10/01/25)
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  • Senior Advisor/ Director Global

    Lilly (Indianapolis, IN)
    …them all over the world. The Senior Advisor/ Director Post approval scientist in Global Regulatory Affairs - CMC commercial solid oral products will use ... + Development of regulatory strategy and update strategy based upon global regulatory changes. + Provide regulatory guidance to allow CMC teams to… more
    Lilly (09/03/25)
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  • Associate Director , Global

    Organon & Co. (Jersey City, NJ)
    …Product Development Teams and regulatory single point-of-contact for products within Global Regulatory Affairs and outside. + Communicate new ... **Job Description** **The Position** The Associate Director , Global Regulatory Lead...the entire life cycle of the drug. + Represent Global Regulatory Affairs within our… more
    Organon & Co. (07/26/25)
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