- CSL Behring (King Of Prussia, PA)
- …and quality of the statistical analysis plan. Support Biostatistics interactions with regulatory authorities (eg FDA , EMA, PMDA) Be responsible for interpreting ... Biostatistician implements the statistical strategies for the clinical trials and regulatory submissions within the program, and is accountable for the statistical… more
- GE HealthCare (State College, PA)
- …to work in the office daily **Preferred Qualifications** + In-depth knowledge of global regulatory standards (eg, FDA , EU MDR, ISO 13485, ISO 14971) + Experience ... field issues, service needs, and product performance. + Partner with Quality, Regulatory , Service, and Engineering teams to investigate and resolve product issues +… more
- Teleflex (Wyomissing, PA)
- Sr. Regulatory Affairs Associate **Date:** Nov 24, 2025 **Location:** Wyomissing, PA, US **Company:** Teleflex **Expected Travel** : None **Requisition ID** :13077 ... solutions that make a difference in patients' lives. **Position Summary** The Sr Regulatory Affairs (RA) Associate will be responsible for a variety of regulatory… more
- ThermoFisher Scientific (Allentown, PA)
- …people and communities depend on - now and in the future. ROLE: Regulatory Intelligence Manager LOCATION: Fully Remote, East Coast is highly preferred **Position ... Summary** The Regulatory Intelligence Manager will play a pivotal role in...changes, guidance documents, and policy trends across key markets ( FDA , EMA, PMDA, etc.) or stakeholders (EU Commission, ICH,… more
- Highmark Health (Grove City, PA)
- …and Westfield, NY.**_** **GENERAL OVERVIEW:** Create a culture of continuous regulatory readiness through continual proactive risk assessment and mitigation efforts. ... and coordinate all activities related to maintaining an ongoing state of regulatory compliance through proactive risk assessments and mitigation efforts. Manage and… more
- Sumitomo Pharma (Harrisburg, PA)
- …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...to achieve results + Understanding of medical terminology, and FDA and ICH regulations/guidance documents specific to clinical research… more
- Parexel (Harrisburg, PA)
- …and evaluating clinical sections of regulatory applications. + Previous experience with a regulatory agency (such as the FDA or MHRA) as a Senior / Master ... drug development-we help shape it. As a **Senior/Vice President, Technical** on our Regulatory Strategy (RS) team, you'll be at the forefront of innovation, guiding… more
- West Pharmaceutical Services (Exton, PA)
- …+ Minimum 5 years of relevant experience + 2+ years of medical device regulatory experience preferred + Experience with US FDA regulations (Title 21CFR820), EU ... Senior Regulatory Affairs Specialist Requisition ID: 71673 Date: Nov...Date: Nov 4, 2025 Location: Exton, Pennsylvania, US Department: Regulatory Affairs Description: **This is a hybrid position requiring… more
- Cytel (Harrisburg, PA)
- …Medidata Rave, Oracle Inform, Veeva, or similar). + Excellent understanding of ICH-GCP, FDA , EMA, and other global regulatory guidelines. + Strong attention to ... individual brings advanced knowledge of medical terminology, clinical trial processes, regulatory requirements, and coding best practices. The Senior Medical Coder… more
- Medexus Pharma (Pittsburgh, PA)
- …audiences (internal and external). + Knowledge of medical affairs processes, regulatory compliance (GCP, FDA /EMA), pharmacovigilance, and safety reporting. + ... Provide timely and accurate responses to medical inquiries in compliance with regulatory and ethical standards. + Collaborate cross-functionally with Regulatory ,… more