- CSL Behring (King Of Prussia, PA)
- … regulatory outcomes.** **-** **Effectively partner with assigned product/s Global Regulatory Affairs Strategy Team (GRAST) GRL plus other regional, labeling ... meaningful difference worldwide. Could you be our next Senior Manager Regional Regulatory Lead, Hematology ? The...key region (EU, US, Japan)** **-** **Experience working in Regulatory Affairs with agency interaction responsibility with… more
- CSL Behring (King Of Prussia, PA)
- …of 6 years of experience in the life sciences industry, with exposure to regulatory affairs or a related function. -Strong analytical, data interpretation, and ... developing therapies that make a meaningful difference worldwide. Could you be our next Senior Manager , Regulatory Science? The job is in our King of Prussia, PA… more
- Globus Medical, Inc. (Audubon, PA)
- …patients can resume their lives as quickly as possible. **Position Summary** **:** The Manager , Regulatory Affairs , is responsible for preparing, filing and ... up to 10% of the time. **Essential Functions** **:** + Guides the US Regulatory team in preparing and filing 510(k), IDE, PMA submissions, FDA reports, all… more
- Pfizer (Collegeville, PA)
- …You Will Achieve** You will represent Pfizer as an approval liaison in the regulatory affairs team assisting with diagnostics regulatory tasks. You will ... **Senior Manager , Global Regulatory Diagnostics Strategy for...website, online application process and/or interviewing. Requests for any other reason will not be returned. Regulatory Affairs… more
- Globus Medical, Inc. (Audubon, PA)
- …can resume their lives as quickly as possible. **Position Summary:** The Regulatory Affairs Specialist assists with drafting, submitting and gaining clearance ... Obtains and reviews clinical study data with Clinical Data Manager and other Clinical Affairs personnel, as...a plus + Minimum of 2-5 years' experience in Regulatory Affairs in the medical device industry,… more
- Globus Medical, Inc. (Audubon, PA)
- …can resume their lives as quickly as possible. **Position Summary** **:** The Regulatory Affairs Associate assists in drafting, submitting and gaining clearance ... Obtaining and reviewing clinical study data with Clinical Data Manager and other Clinical Affairs personnel, as...device industry or equivalent, preferably within orthopedic medical devices; Regulatory Affairs experience is a plus. +… more
- Insight Global (Chadds Ford, PA)
- …Experience in research and drug development areas (Clinical Operations, Data Management, Regulatory Affairs , Pharmacovigilance, Finance, HR, Medical Affairs ) ... Job Description We are seeking a Project Manager to oversee our pharmaceutical client's Robotic Process Automation (RPA) and AI/ML portfolio, collaborating with… more
- Globus Medical, Inc. (Audubon, PA)
- …technique guides, brochures and other marketing/sales support materials + Partnering with Regulatory Affairs in planning, coordination, writing, and execution of ... 510(k), IDE & PMA submissions and approvals + Collaborating with VP, Strategy & Corporate Development to ensure that Globus can attract and retain the best orthopedic/trauma surgeons to serve on product development teams, surgeon boards, think tanks, podium… more