- Takeda Pharmaceuticals (Trenton, NJ)
- …is possible in order to bring life-changing therapies to patients worldwide. Join Takeda as a US Lead , Global Regulatory Policy and Innovation where you ... serve as US expert and subject matter lead for regulatory policy and advocacy activities,...Policy Innovation, you will report to Executive Director & US Head, Global Regulatory Policy… more
- Novo Nordisk (Plainsboro, NJ)
- … regulatory expert who wants to work with innovative investigational medicines. You will lead a global regulatory team to develop and execute ... human health starts here and that patients rely on us . We're changing lives for a living. Are you...Relationships You will report to the Senior Director - Global Regulatory Portfolio Lead . Essential… more
- Sanofi Group (Bridgewater, NJ)
- **Job title: Global Regulatory Lead ** +...Life Science, or related field) is preferred. **Why choose us ?** + Bring the miracles of science to life ... possible. Ready to get started? **Main responsibilities:** + As Global Regulatory Affairs Lead (GRL),...14 weeks' gender-neutral parental leave. Sanofi Inc. and its US affiliates are Equal Opportunity and Affirmative Action employers… more
- Takeda Pharmaceuticals (Trenton, NJ)
- …our Global Regulatory Affairs organization, based remotely. + Partners with the Global Regulatory Lead (GRL) on Global Regulatory Teams ... shine? Join us as an Associate Director, Global Regulatory Project Management and Strategic Planning...**How you will contribute:** + Partnering with the program Global Regulatory Lead (GRL), co-… more
- Merck (Upper Gwynedd, PA)
- …and obtain shortest time to approval by regulatory agencies. + Functions as global regulatory lead assigned to programs where the compound is ... submissions and associated documentation. + Provides expertise as the Global Regulatory Lead to Product...in certain states and cities within the United States . Final determinations with respect to… more
- J&J Family of Companies (Titusville, NJ)
- …plan, risk and opportunity playbooks, scenario evaluation and business case development). + Lead operations with Global Regulatory Team (GRT), including ... projects forward through the translation and distillation of overall global regulatory strategy to executable plans and...in this posting applies to candidates hired in the United States . Candidates hired outside the … more
- Takeda Pharmaceuticals (Trenton, NJ)
- …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...Represents Global Labeling at Global Regulatory Team (GRT) + Liaises with US … more
- Merck (North Wales, PA)
- …review and final approval for all submissions and associated documentation. Provides expertise as Global Regulatory Lead to Product Development Teams and ... targeted product labeling + Provide expert advice as the Global Regulatory Lead to Product...in certain states and cities within the United States . Final determinations with respect to… more
- Sanofi Group (Bridgewater, NJ)
- …of the Global Regulatory Team (GRT), and strategic partner to the Global Regulatory Lead (GRL), the Regulatory Strategist (RS) leverages their ... strategy, to enable and drive the execution of aligned US , EU and/or global regulatory ...management of products. + May serve as a regional/local regulatory lead and point of contact with… more
- Copeland (Trenton, NJ)
- **About Us ** We are a global climate...will be responsible for processing region payroll in the United States and Canada using ADP GlobalView ... the marketplace knowledge, skills, and competencies to compete and lead in a global economy. Our training...those who are legally authorized to work in the United States . This is not a position… 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 ... and vaccines. **What You Will Achieve** The Senior Manager, Global Regulatory Strategy for Oncology provides support...are aligned based on the location of hire. The United States salary range provided does not… more
- J&J Family of Companies (Titusville, NJ)
- Director, Global Regulatory Leader (GRL) - 2406184564W...payor demands) + Lead the preparation of regulatory dossiers for submissions to US FDA. ... & Johnson Innovative Medicine is recruiting for a Director, Global Regulatory Affairs Leader located in New...more at www.janssen.com . Key Responsibilities: + Bring innovative regulatory approaches, deeply rooted in science, to lead… more
- Pfizer (Collegeville, PA)
- …as a key interface between the Pfizer Oncology Global Medical Strategy Lead / MST, Pfizer US (Medical Platforms), Pfizer International Medical teams and ... Affairs, Pfizer US (Medical Platforms), Safety, Oncology Regulatory Strategy, Global Value and Access and...are aligned based on the location of hire. The United States salary range provided does not… more
- Pfizer (Collegeville, PA)
- …Act and IRCA. Pfizer is an E-Verify employer. This position requires permanent work authorization in the United States . Regulatory Affairs \#LI-PFE ... assessments + Act as the primary labeling representative on Global Regulatory Strategy Teams, Submission Working Groups,...are aligned based on the location of hire. The United States salary range provided does not… more
- Pfizer (Collegeville, PA)
- …compensation structures and benefit packages are aligned based on the location of hire. The United States salary range provided does not apply to Tampa, FL or ... **ROLE SUMMARY** The Global Development Lead will be responsible...any location outside of the United States . Relocation assistance may be available… more
- Olympus Corporation of the Americas (Center Valley, PA)
- …to email, you may call our HR Compliance Manager at 1-888-Olympus (###). Posting Notes: || United States ( US ) || Pennsylvania ( US -PA) || Center Valley || ... strategies for promotion and advertising campaigns, including serving as regulatory lead for materials required for product... for materials required for product launches in the United States for all divisions of Olympus.… more
- Merck (Trenton, NJ)
- … CMC Oversight + Lead the preparation and submission of high-quality regulatory CMC device content for global submissions, including IND, NDA, BLA, and ... regulatory guidelines and trends. + Collaborate with global regulatory teams to align strategies and...in certain states and cities within the United States . Final determinations with respect to… more
- Merck (Trenton, NJ)
- …are not limited to:_** + Lead a cross-functional team to standardize global medical device requirements including US , EU, UK, Switzerland, Canada, Japan, ... position will be part of the Device Quality & Regulatory Team within Global Regulatory ...in certain states and cities within the United States . Final determinations with respect to… more
- Bristol Myers Squibb (Princeton, NJ)
- …to:** + New Product Portfolio working closely with their TA counterparts in Global Regulatory Strategy, Worldwide Patient Safety (WWPS), Clinical Development and ... **Working with Us ** Challenging. Meaningful. Life-changing. Those aren't words that...global compliant labels. Position will also serve as Global Labeling Lead for assigned products. **Responsibilities… more
- Organon & Co. (Plymouth Meeting, PA)
- …are position specific. Please, no phone calls or emails. **Applicable to United States Positions Only:** Under various US state laws, Organon is required to ... Provide Regulatory CMC and oversight in developing global Regulatory CMC strategies and executing submissions... CMC scientists in the Organon franchise teams. + Lead development and execution of regulatory CMC… more