- Organon & Co. (Plymouth Meeting, PA)
- **Job Description** **The Position** The Associate Director, Global Regulatory Lead (GRL), reporting to the Executive Director, Senior Director or Director, Global ... will be responsible for the development and implementation of world-wide regulatory strategies for projects in their assigned therapeutic area portfolio.… more
- Merck (North Wales, PA)
- **Job Description** The Global Regulatory Liaison is responsible for developing and implementing worldwide regulatory strategies for assigned projects within the ... point of contact, with significant experience, the Liaison provides strategic regulatory oversight to accelerate approvals and optimize product labeling. This… more
- United Therapeutics (Harrisburg, PA)
- … affairs or a related area of study or 7+ years of biologic or pharma regulatory experience with a PhD in life sciences, quality, regulatory affairs or ... hearts. **Who you are** We are looking for a regulatory strategist who will advise on regulatory ...a regulatory strategist who will advise on regulatory pathways, managing documentation and timelines, and supporting the… more
- Pfizer (Collegeville, PA)
- …Is What You Need (Minimum Requirements)** + BS is required. MS, PharmD, or PhD preferred + Prior clinical regulatory affairs experience in vaccines is required, ... local and global regulations is crucial, and the constantly evolving regulatory landscape demands forward-thinking and meticulous attention to detail. Your… more
- Otsuka America Pharmaceutical Inc. (Harrisburg, PA)
- …and/or review technical reports, protocols, risk assessments, and relevant sections of regulatory submissions (IND, BLA, MAA, etc.) related to upstream processing. + ... Collaborate closely with Downstream MSAT, Validation MSAT, QA, Regulatory , Process Development, and CDMO technical teams. + Stay current with advancements in… more
- Otsuka America Pharmaceutical Inc. (Harrisburg, PA)
- …review technical reports, protocols, risk assessments, and relevant sections of regulatory submissions (IND, BLA, MAA, etc.) related to downstream processing. + ... Collaborate closely with Upstream MSAT, Validation MSAT, QA, Regulatory , Process Development, Analytical Development, and CDMO technical teams. + Stay current with… more
- West Pharmaceutical Services (Exton, PA)
- …+ Minimum 5 years Bachelor's with 5+ years required; or + Master's degree/ PhD 2+ years medical device regulatory experience required **Preferred Knowledge, ... Sr. Specialist, Regulatory Affairs, Product Stewardship Requisition ID: 69466 Date:...science, math, engineering, or related discipline preferred or + PhD in science, math, engineering, or related discipline preferred… more
- CSL Behring (PA)
- …transplantation and burn treatment. Could you be our next Senior Manager, Analyst, Regulatory Science, Policy, and Intelligence? The job is in our Washington DC ... position. You will report to the Head of Global Regulatory Science, Policy, and Intelligence. You will provide strategic...+ Bachelor's degree in life sciences, PharmD, JD, or PhD preferred + 3+ years of experience in the… more
- J&J Family of Companies (Horsham, PA)
- …**Job Function:** Discovery & Pre-Clinical/Clinical Development **Job Sub** **Function:** Regulatory Science **Job Category:** People Leader **All Job Posting ... R&D is recruiting for a Director, CMC (Chemistry, Manufacturing and Controls) Regulatory Affairs Biologics New Modalities. This position is a hybrid role and… more
- Merck (North Wales, PA)
- **Job Description** At the heart of innovation, our Regulatory Affairs team plays a vital role in delivering new medical advancements to patients around the world. ... and establishing robust procedures, we ensure swift, organized compliance with global regulatory agencies. As an international network on the leading edge of… more
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