- Merck & Co. (North Wales, PA)
- …IEP) is a role within Global Medical and Value Capabilities (GMVC) in Global Medical and Scientific Affairs (GMSA) that reports directly to the Director, ... regulatory guidelines and compliance requirements pertaining to Medical Affairs operations, and, preferably, experience in navigating regulatory challenges… more
- Merck (Upper Gwynedd, PA)
- … Affairs , General Medicine, will contribute to the mission and vision of the Global Regulatory Affairs and Clinical Safety (GRACS) function of our ... model to maintain best-in-industry regulatory compliance. The Vice President Regulatory Affairs , General Medicine is accountable for: + Directing and… more
- Merck (North Wales, PA)
- …final approval of all submissions and associated documentation. + Provides expertise as the Global Regulatory Lead to Product Development Teams and ... regulatory single point-of-contact for products within Global Regulatory Affairs and Clinical...to Executive Director or Associate Vice President, Therapeutic Area Lead . + Develops worldwide product regulatory strategy… more
- Teva Pharmaceuticals (West Chester, PA)
- …difference, and new people to make a difference with. **The opportunity** The Sr. Director, Global Regulatory Affairs CMC is responsible to oversee and help ... Senior Director Regulatory Affairs CMC (Biologic Products) Date:...major market health authorities as well as coordinating with global regulatory colleagues in preparing dossiers for… more
- J&J Family of Companies (Spring House, PA)
- …compounds and compounds in clinical development within the Immunology TA. The GMAL will lead the Global Medical Affairs Team and partner closely with ... areas. Be an active member of the CDT and lead a Global Medical Affairs ...Excellent knowledge of study execution, benefit risk management and regulatory affairs . + Proven ability to act… more
- J&J Family of Companies (Horsham, PA)
- …Immunology TA. He/she will lead or be a key participant in the Global Medical Affairs Strategy Team (G-MAST) and partner closely with Regional Medical ... inclusive of developing a Target Product Profile representing Medical Affairs global and regional value needs. +...Excellent knowledge of study execution, benefit risk management and regulatory affairs is highly preferred. Expertise with… more
- Pfizer (Collegeville, PA)
- …communications between and across all stakeholder groups. **ROLE RESPONSIBILITIES** The Scientific Affairs lead will work closely with the relevant groups in ... communication skills, along with industry knowledge, to support Head of Scientific Affairs & Strategic Partnerships and Pfizer Oncology Leadership Team (LT) in… more
- J&J Family of Companies (Horsham, PA)
- …skills and the ability to influence is necessary * Experience interacting with global regulatory authorities is also desirable * Approximately 20% travel ... portfolio of IMM products. She/he will partner with colleagues from Commercial, R&D, Global Medical Affairs , Real-world Value & Evidence, Biostatistics, and work… more
- J&J Family of Companies (West Chester, PA)
- …* Work with cross-functional partners, including but not limited to R&D, Clinical Affairs , Regulatory Affairs , Health Economics & Market Access (HEMA) ... documents. * Lead , mentor and coach a team of Medical Affairs professionals. **Qualifications** **Requirements** + Must have an MD or equivalent. + Completion… more
- Integra LifeSciences (PA)
- …possible and making headway to help improve outcomes. Reporting to the Sr. Director, Global Medical Affairs , Wound Reconstruction and Care, we are seeking a ... Responsible for approval of medical and scientific content of Regulatory , Safety, Medical Affairs , and Commercial inputs...materials, slide sets, abstracts, posters, etc. + Participate or lead as needed the review and assessment of new… more
- University of Pennsylvania (Philadelphia, PA)
- …and ensure optimal communication across stakeholders. Responsibilities will also include providing regulatory support and oversight for the global and newly ... and resources, and much more. Posted Job Title Associate Director, Student Affairs , Graduate Programs (Department of Radiation Oncology) Job Profile Title Associate… more
- Takeda Pharmaceuticals (Harrisburg, PA)
- … Project Management and Strategic Planning - Neuroscience where you will partner with the Global Regulatory Lead (GRL) on Global Regulatory ... Project Management and be a part of the Global Regulatory Affairs Team. **How...and Strategic Planning, you will partner with the program Global Regulatory Lead (GRL), co-… more
- Pfizer (Collegeville, PA)
- …can be considered. + Extensive direct regulatory experience, preferably including as a Global Regulatory Lead and leading a GRST. + Advanced knowledge of ... Achieve** You will represent Pfizer as anApprovalLiaison in the regulatory affairs team. You will play the...a Director, Lead and coordinate a virtual global regulatory strategy team (GRST), encompassing regional… more
- Sanofi Group (Swiftwater, PA)
- …+ Location: Bridgewater, NJ or Swiftwater, PA or Cambridge, MA **About the job** The Global Regulatory Affairs Device team is a globally diverse team ... portfolio of products. The team is part of the Global Regulatory Affairs , Regulatory...and approve regulatory design control deliverables. + Lead and/or support global filing activities for… more
- Organon & Co. (Plymouth Meeting, PA)
- …products through the product lifecycle. + Lead development and execution of global product and project regulatory strategies by ensuring robust assessment of ... CMC changes, identification of global regulatory requirements, and critical evaluation of...business processes and systems. + Demonstrate an understanding of regulatory affairs and apply this understanding to… more
- J&J Family of Companies (Spring House, PA)
- …Technical Product Manager Regulatory Strategy - 2406192765W **Description** The R&D Global Regulatory Affairs business technology team is focused on ... leading-edge technology solutions to help drive J&J Innovative Medicine's Global Regulatory Affairs organization, The...business customers. The IT Senior Manager TPM has a lead role in the execution of IT product management… more
- J&J Family of Companies (Spring House, PA)
- …tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com/. The Global Regulatory Affairs business technology team is focused on ... leading-edge technology solutions to help drive J&J Innovative Medicine's Global Regulatory Affairs organization, we...lead role in the development of a Unified Regulatory Platform (URP) and will lead technical… more
- Merck (Upper Gwynedd, PA)
- … requirements + Serving as regulatory labeling point of contact on global Regulatory Affairs sub-teams to ensure delivery of labeling documents ... **Job Description** The purpose of the Global Labeling Therapeutic Area group is to drive...and US labeling for marketed products; and supporting country Regulatory Affairs in the development and maintenance… more
- Takeda Pharmaceuticals (Harrisburg, PA)
- …Management + Appropriately escalates issues to Global Labeling management and the Global Regulatory Lead (GRL) and proposes risk mitigation strategies ... therapies to patients worldwide. Join Takeda as Associate Director, Global Labeling Lead where you will be...+ Working within Labeling Team and GRA + Represents Global Labeling at Global Regulatory … more
- Pfizer (Collegeville, PA)
- …and Nationality Act and IRCA. Pfizer is an E-Verify employer. This position requires permanent work authorization in the United States. Regulatory Affairs ... willing to compromise on excellence and integrity. Adhering to local and global regulations is essential and the ever-changing regulatory environment requires… more
