• Regulatory Affairs Consultant - Labeling…

    Parexel (Harrisburg, PA)
    …5 years of biotech/pharma industry experience, including 2+ years in labeling/ regulatory operations with global responsibility. * Experience leading teams ... Join us as a **Global Labeling Operations Manager** , where you'll work alongside a...AU) and non-US/Central EU markets, ensuring compliance with global regulatory requirements and supporting cross-functional teams in delivering accurate,… more
    Parexel (12/13/25)
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  • Associate Director, Regulatory Affairs…

    Sumitomo Pharma (Harrisburg, PA)
    …coordinates, authors, and prepares regulatory submissions and works closely with Regulatory Operations in the electronic submission + Ensure compliance with ... Pharma Co., Ltd., is a global pharmaceutical company based in Japan with operations in the US (Sumitomo Pharma America, Inc.), focused on addressing patient needs… more
    Sumitomo Pharma (10/11/25)
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  • Associate Director, Regulatory

    University of Pennsylvania (Philadelphia, PA)
    …the Director in providing direction and strategic planning for clinical research regulatory operations including overseeing the activities of a Regulatory ... the Director in providing direction and strategic planning for clinical research regulatory operations including overseeing the activities of a Regulatory more
    University of Pennsylvania (10/09/25)
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  • Senior Manager, Global Regulatory Affairs

    Otsuka America Pharmaceutical Inc. (Harrisburg, PA)
    …global regulatory team (GRL, regional leads, CMC-RA, labeling, medical writing, regulatory operations , etc.) to develop global regulatory plans, address ... **Position Summary** Provides critical support in developing global regulatory strategy, planning and execution of global investigational and marketed prescription… more
    Otsuka America Pharmaceutical Inc. (11/20/25)
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  • Principal Technical Program Manager - Health…

    Oracle (Harrisburg, PA)
    …Data Intelligence (HDI) is hiring a Principal Technical Program Manager - Operations to lead key strategic and operational initiatives across the organization. This ... is a highly visible role where you'll report directly to the Director of Operations as a right-hand leader and help scale programs, headcount, tooling, and processes… more
    Oracle (11/25/25)
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  • Associate Director, Submissions Content Source…

    Merck (North Wales, PA)
    …Coordination, IT Operation, Pharmacovigilance, Policy Implementation, Regulatory Compliance, Regulatory Labeling, Regulatory Operations , Regulatory ... DAYS PER WEEK) The Submissions Content Source Management Business Operations Lead is expected to understand the end-to-end ...Operations Lead is expected to understand the end-to-end regulatory submission process. The main focus will be on… more
    Merck (12/11/25)
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  • CAT/Cais Reporting Analyst -Remote Flexibility…

    Raymond James Financial, Inc. (Harrisburg, PA)
    …of the following corporate home office locations: Memphis, TN or Southfield, MI. The Regulatory Operations Analyst ( _CAT/CAIS Reporting Analyst_ ) plays a key ... future._** We are seeking a detail-oriented professional with hands-on experience in regulatory reporting, specifically with **CAT** and **CAIS** , to support our… more
    Raymond James Financial, Inc. (09/30/25)
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  • Director Of Operations

    ATS Automation (Souderton, PA)
    …production environment for >8 years. + Well versed in manufacturing operations , regulatory compliance, and planning development - including supply-chain, ... Location: Souderton, PA, US, 18964 Date: Nov 26, 2025 Director Of Operations Position Title:Director Of Operations , NCC Automated System Location:Souderton,… more
    ATS Automation (12/04/25)
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  • Principal TPM, SaMD (Remote)

    Oracle (Harrisburg, PA)
    …central point of coordination across Engineering, Product, Security, Quality, Risk, Regulatory , and Operations . + Influence architecture, delivery processes, and ... visible leadership position, you will drive programs that integrate SaMD regulatory requirements into engineering workflows, SDLC practices, release processes, and… more
    Oracle (12/11/25)
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  • Director, Training Management Operations

    Otsuka America Pharmaceutical Inc. (Harrisburg, PA)
    …is responsible for overseeing the end-to-end management of global training operations , ensuring compliance with regulatory requirements, operational efficiency, ... + Serve as the primary point of contact for training operations during regulatory inspections and internal audits. **Training Systems & Technology Enablement** +… more
    Otsuka America Pharmaceutical Inc. (12/06/25)
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