- Charles River Laboratories (Wayne, PA)
- …construction, and new processes. ⦁ Participate in development and revision of regulatory submissions , eg, license applications, supplements, annual reports, and ... or more Charles River operations and serves as a member of the Regulatory Affairs and Compliance management team. Provides direction in implementing the Charles… more
- Vanguard (Malvern, PA)
- … regulatory enforcement risk and pending matters. + Draft and negotiate regulatory submissions , legal memos, agreements, and other legal documents and ... Join a dynamic legal team where your expertise will drive high-impact regulatory response and investigative work. This role offers the opportunity to lead responses… more
- Merck (North Wales, PA)
- …preparation for regulatory advisory committee meetings. + Coordinate regional regulatory strategy and submissions through collaboration with Regulatory ... **Job Description** At the heart of innovation, our Regulatory Affairs team plays a vital role in...+ Conduct initial content review and approval for IND/CSA submissions to enable clinical trial initiation. + Participate in… more
- West Pharmaceutical Services (Exton, PA)
- …+ Provide customers with West product compliance information and data as required for regulatory compliance and submissions to North America, Europe, and Rest of ... Sr. Specialist, Regulatory Affairs, Product Stewardship Requisition ID: 69466 Date:...Date: Aug 9, 2025 Location: Exton, Pennsylvania, US Department: Regulatory Affairs Description: **_This role is a remote role… more
- IQVIA (Wayne, PA)
- …C meetings with FDA + Experience in developing patient experience materials for regulatory consultations and submissions (eg COA dossier, briefing documents for ... The Head of the Center of Excellence (CoE) for Regulatory Strategy sits within the COA consulting business of...strategies to engage US FDA, the EMA and other regulatory agencies on COA endpoints and the use of… more
- Organon & Co. (Plymouth Meeting, PA)
- …follow-up contact with regulatory agencies and/or subsidiaries for all applications and submissions . + Conduct Regulatory review and final approval of all ... **Job Description** **The Position** The Associate Director, Global Regulatory Lead (GRL), reporting to the Executive Director, Senior Director or Director, Global… more
- Globus Medical, Inc. (Audubon, PA)
- …of clinical trials applications. **Essential Functions** **:** + Demonstrates global regulatory expertise in product submissions and evaluates changes with ... and regional registration requirements. Compiles all materials required in submissions , license renewal and annual registrations. Recommends changes for labeling,… more
- Pfizer (Collegeville, PA)
- …publishing manuscripts through co-authorship. The candidate may also provide support in regulatory submissions including responses to regulatory queries. ... + Provide scientifically rigorous statistical input into project development plans, regulatory submissions , interpretation of statistical results, study design,… more
- Pfizer (Collegeville, PA)
- …scope. + Provides operational excellence, planning, and execution leading to successful regulatory submissions and approvals. + Provides support to the team ... sub-committees and steering committees, in particular the joint development committee. ** Submissions ** + Provides comprehensive project management for regulatory … more
- Merck (North Wales, PA)
- …applied to designing and analyzing clinical trials in support of worldwide regulatory submissions . This position involves interaction with Medical, Data ... Management, Data Science, Numerical Analysis, Physiology, Regulatory Compliance, Regulatory Requirements, Regulatory Submissions , Scientific Modeling,… more