- Merck (Upper Gwynedd, PA)
- **Job Description** We are seeking a Director (Principal Scientist), Global Regulatory Affairs Liaison with a visionary, growth-oriented mindset that can ... advance our pipeline and drive our strategic priorities. The Director , Principal Scientist | Regulatory Affairs...and regulatory single point-of-contact for products within Global Regulatory Affairs and Clinical… more
- J&J Family of Companies (Trenton, NJ)
- …(GRL) - 2406184564W **Description** Johnson & Johnson Innovative Medicine is recruiting for a Director , Global Regulatory Affairs Leader located in New ... Director , Global Regulatory Leader...authority regulated industry + At least 6 years of Regulatory Affairs experience required with focus on the… more
- Merck (North Wales, PA)
- …Description** We are seeking a Senior Director (Sr. Principal Scientist) Global Regulatory Affairs Liaison with a visionary, growth-oriented mindset ... and regulatory single point-of-contact for products within Global Regulatory Affairs and Clinical...external to GRACS. **Key Functions** + Reports to Executive Director or Associate Vice President, General Medicine + Works… more
- J&J Family of Companies (Trenton, NJ)
- Associate Director , CMC Regulatory Affairs ...product and is in alignment with the strategies of global regulatory affairs , the therapeutic ... **Description** Johnson & Johnson is recruiting for an Associate Director , CMC Regulatory Affairs . This... strategy through partnership and communication with Therapeutic Area Regulatory Affairs ( Global Regulatory… more
- Merck (Philadelphia, PA)
- …accountable, global regulatory point of contact on those projects within Global Regulatory Affairs and Clinical Safety (GRACS) and external to GRACS. ... release from our company to external agencies and investigators. + Represents Global Regulatory Affairs (GR) within internal committees to provide … more
- Merck (North Wales, PA)
- …standards and policies and business objectives. Actively participate in labeling and global regulatory team meetings to ensure support for anticipated ... **Job Description** Reports to the Director /Senior Director in the Office of...all US promotional materials and serving as the promotional regulatory expert with marketing, legal, and medical teams to… more
- Organon & Co. (Plymouth Meeting, PA)
- …agile manner. + Provide Regulatory CMC and oversight in developing global Regulatory CMC strategies and executing submissions related to diverse late-stage ... Position** Reporting to the Director or Executive Director in Organon Regulatory CMC New Products,...participating in Agency meetings on CMC topics, and executing global initial marketing applications with a line of sight… more
- Takeda Pharmaceuticals (Trenton, NJ)
- … Regulatory Project Management and Strategic Planning - GI2 TAU within our Global Regulatory Affairs organization, based remotely. + Partners with the ... implementing process changes through proactive engagements with cross functional team members, Global Regulatory Affairs TAU colleagues and Global … more
- Merck (North Wales, PA)
- …position operates under the guidance of the Associate Director who supports the Global Regulatory Affairs & Clinical Safety (GRACS) and Quality Assurance ... + Provide financial planning, forecasting and analytical support to ourResearch&DevelopmentDivision, Global Regulatory Affairs & Clinical Safety (GRACS),… more
- Merck (Trenton, NJ)
- …up with the latest regulatory guidelines and trends. + Collaborate with global regulatory teams to align strategies and ensure submission readiness in all ... **Job Description** The Executive Director , Device Quality & Regulatory will...emerging regulations and industry trends affecting device quality and regulatory affairs . Strategic Contributions + Serve as… more
- Takeda Pharmaceuticals (Trenton, NJ)
- …cross-functional team members (Clinical, Global Patient Safety, Program Management, Global Regulatory , Regulatory Operations, Drug Discovery Units, ... FDA/EMA/PMDA regulations; ICH guidance; GLP/GCP requirements; SEND requirements, etc.). + Regulatory Affairs Credential (RAC-Drugs) is an advantage. + Strong… more
- Merck (North Wales, PA)
- **Job Description** We are currently recruiting for a ** Director Global Oncology Marketing** for Lung cancer for our Company's oncology business. The Global ... in Rahway, NJ and will report to the Executive Director , Global Marketing for NSCLC. The position...complex set of stakeholders, including research and development, medical affairs , regulatory affairs , market analytics,… more
- Takeda Pharmaceuticals (Trenton, NJ)
- …+ Appropriately escalates issues to Global Labeling management and the Global Regulatory Lead (GRL) and proposes risk mitigation strategies for assigned ... life-changing therapies to patients worldwide. Join Takeda as Associate Director , Global Labeling Lead where you will...+ Working within Labeling Team and GRA + Represents Global Labeling at Global Regulatory … more
- Takeda Pharmaceuticals (Trenton, NJ)
- …Liaise with and advise study teams including Clinical Science, Data Management, Regulatory Affairs , and other functional areas locally/globally on matters ... of clinical trial and Pharmacovigilance methodologies including detailed comprehension of global regulatory requirements. + Good cross-cultural understanding and… more
- Merck (North Wales, PA)
- …Work effectively with cross-functional partners including research and development, medical affairs , regulatory affairs , manufacturing, Business Development ... competitive strategy, target product profile development, health authority interactions, global regulatory filing strategy, launch readiness reviews, organized… more
- Spark Therapeutics Inc. (Philadelphia, PA)
- …Lead will provide clinical development support and guidance into global regulatory interactions, will assist the Medical Affairs team, as necessary, and ... Senior Medical Director - Neurology **Date:** Oct 13, 2024 **Location:**...internally as clinical development expert for global regulatory interactions; collaborate with Regulatory Affairs… more
- J&J Family of Companies (Titusville, NJ)
- …clinical operations, project management, quality monitoring & compliance, data management, global medical safety, biostatistics, regulatory affairs , clinical ... Data Monitoring Committee (IDMC) and adjudication meetings as needed + Assists Regulatory Affairs in determining requirements for any corrective actions or… more
- Cardinal Health (Trenton, NJ)
- …of capacities, including: + Global Regulatory Strategy Development + Global Regulatory Affairs + Chemistry Manufacturing and Controls (CMC) ... selling to Pharmaceutical, Biotech and Medical Device companies client preferred. + Regulatory affairs , drug development understanding is highly preferred. +… more
- Merck (North Wales, PA)
- …to address the opportunities. + Collaborating with Global Medical and Scientific Affairs (GMSA), US, Senior Director of Medical Affairs (SDMA), Center ... **Job Description** **Job Description:** The Associate Director , Marketing, HPV Scientific Strategy plays a critical...One Company approach. + Collaborating with Program Leads, Medical Affairs and Global Expert Management & Strategy… more
- Organon & Co. (Plymouth Meeting, PA)
- …cross-functional colleagues in preclinical science, data science, clinical operations, regulatory affairs , chemistry, manufacturing and control (CMC), project ... position can be 100% remote in the US** The Director , Translational Medicine and Early Development (TMED) Lead will...are sound, based on the most up-to-date literature and regulatory guidances and support the approved early development plans.… more