- GRAIL (Harrisburg, PA)
- …products with the FDA and/or global health authorities. + Support the US Regulatory Affairs team in preparing submissions such as PMAs, 510(k)s, post-approval ... and leadership. They may manage and provide direction to regulatory staff and, when required, participate in senior...of Standard Operating Procedures and policy guidelines within the regulatory affairs department. + Perform other duties… more
- Teleflex (Wyomissing, PA)
- Sr. Regulatory Affairs Associate **Date:** Nov 24, 2025 **Location:** Wyomissing, PA, US **Company:** Teleflex **Expected Travel** : None **Requisition ID** ... a difference in patients' lives. **Position Summary** The Sr Regulatory Affairs (RA) Associate will...quality system compliance requirements. The Senior RA Associate will partner with Product Management Regulatory … more
- Sumitomo Pharma (Harrisburg, PA)
- …seeking a dynamic, highly motivated, and experienced individual for the position of ** Associate Director, Regulatory Affairs (Oncology).** The Associate ... Director is part of the Global Regulatory Affairs (GRA) team based in the US. He/She will...Comfortable presenting to all levels of the organization including Senior Management. **Education and Experience** + Bachelor's degree in… more
- CSL Behring (King Of Prussia, PA)
- Associate Director, Corporate & External Affairs , R&D Portfolio **Position Purpose:** The Associate Director, Corporate and External Affairs , R&D ... Relationships:** + **Reports to:** Head of Corporate and External Affairs , R&D + **Direct reports to position:** 1 **Main...and partners. + Serve as a key partner to regulatory policy team providing strategic counsel on advocacy opportunities,… more
- University of Pennsylvania (Philadelphia, PA)
- … Regulatory Job Description Summary With the oversight of the Director, the Associate Director for Regulatory Affairs will oversee the portfolio of ... clinical research undertaken within the department/division. The Associate Director for Regulatory Affairs assists the Director in providing direction and… more
- Otsuka America Pharmaceutical Inc. (Harrisburg, PA)
- …development programs. + Build professional network with key stakeholders outside of Global Regulatory Affairs to identify regulatory intelligence needs and ... The Associate Director of Regulatory Intelligence leads...technical discipline preferred. + Minimum of 5 years of regulatory affairs experience. + Minimum 2-3 years'… more
- Duquesne Light Company (Pittsburgh, PA)
- …innovation and outcomes. We want you to join our team! **Job Title:** Regulatory Cons Rel Associate I **Position Summary:** To investigate customer driven ... solution however the recommendations are frequently presented to their manager or more senior level professionals for review and approval prior to the decision being… more
- United Therapeutics (Philadelphia, PA)
- …communication with teammates and appreciate the opportunity to collaborate with senior management, CPLs, MSL Field Directors, MSLs, Medical Communications and ... (slides, FAQ, talking points etc.) + Partner with Global Medical Affairs /product development, and global partners' subject matter experts to develop/execute disease… more
- Merck (Upper Gwynedd, PA)
- …Work closely with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical development ... radically changes the way we approach serious diseases. The Senior Director will report to an Associate ...Medical Research, Mentorship, Plan of Action and Milestones (POA&M), Regulatory Affairs Compliance, Regulatory Compliance… more
- Otsuka America Pharmaceutical Inc. (Harrisburg, PA)
- …statistical sections. + Discusses strategies with Global Clinical Development and Regulatory Affairs regarding study design and complex analysis issues, ... team and key stakeholders across different functional areas such as clinical, regulatory affairs , asset management, safety and clinical operation. + Familiar… more