- Daiichi Sankyo, Inc. (Bernards, NJ)
- …including working with contract manufacturing organizations CMO. This position serves as the Regulatory Affairs (RA) CMC project representative to the ... 8-10 years pharmaceutical industry experience with 4+ years direct or related CMC regulatory experience orPhD. with 6-8 years pharmaceutical industry experience… more
- Aequor (Thousand Oaks, CA)
- …a mixed background not just lab but manufacturing and process development. This manager position within CMC will facilitate product development and global ... registration by developing and executing regulatory strategies and effective regulatory agency interactions for product manufacturing and quality programs… more
- Tris Pharma (Monmouth Junction, NJ)
- …This includes, but is not limited to: Research, Product Development, Clinical Development, Regulatory Affairs , CMC , New Products, Sales & Marketing, and ... in our Monmouth Junction, NJ facility for a Senior Manager , Business Development.The primary role of the Senior ...input on deal terms and creation of relevant clinical, regulatory , and commercial scenarios Prepare clear and concise presentations… more
- Astellas Pharma (Westborough, MA)
- ** Regulatory Manager , Regulatory Affairs - CMC (Gene Therapy)** Do you want to be part of an inclusive team that works to develop innovative ... lead or deputy for complex projects/products, requiring advice from manager on complex issues. + Manages technical documents for...for eligible positions + Referral bonus program \#LI-TR1 Category Regulatory Affairs CMC Astellas is… more
- Sanofi Group (Bridgewater, NJ)
- **Job title:** Manager , Regulatory Affairs CMC - Vaccine + Location: Swiftwater, PA or Bridgewater, NJ (hybrid working schedule) + % of travel expected: ... a Manager and you'll develop the Global Regulatory CMC strategies for development and marketed... strategies for development and marketed products within Global Regulatory Affairs . You'll have direct contact/liaison with… more
- BeiGene (San Mateo, CA)
- **General Description:** + The Manager , Regulatory Affairs CMC , is responsible for developing and implementing global regulatory CMC strategies ... a scientific discipline with minimum 5+ years of experience in a global CMC regulatory affairs position (with expertise in biologics and deep experience in… more
- Gilead Sciences, Inc. (Foster City, CA)
- …worldwide, with headquarters in Foster City, California **About the role:** The CMC Regulatory Affairs Sr. Manager at Gilead is responsible for providing ... contributes to global process improvements, which have a significant impact for the Regulatory Affairs CMC Department or development matrix teams + Coach and… more
- Regeneron Pharmaceuticals (Tarrytown, NY)
- …this role, a typical day might include the following:** + Responsible for CMC /CP product development activities to lead the regulatory standpoint during early ... for program-specific discussions, connect the dots across IOPS, proactively identify CMC /CP regulatory issues and develop appropriate strategies to mitigate… more
- Takeda Pharmaceuticals (Columbus, OH)
- …motivated and qualified regulatory CMC professional for the Global Regulatory Affairs CMC & Device organization in the Plasma-Derived Therapies ... Business Unit at Takeda. The Global Regulatory Affairs CMC & Device...market launch and product lifecycle management. The Strategist (Sr Manager ) works in a highly highly matrixed, global product… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …including working with contract manufacturing organizations CMO.** This position serves as the Regulatory Affairs (RA) CMC project representative to the ... with 8-10 years pharmaceutical industry experience with 4+ years direct or related CMC regulatory experience or + PhD. with 6-8 years pharmaceutical industry… more
- Ascendis Pharma (Palo Alto, CA)
- …perspectives to all aspects of the business, from drug development to marketing. The Manager , Regulatory Affairs will be responsible for supporting and ... Alto, CA and reports directly to the Head of Regulatory Affairs . Key Responsibilities + Responsible for.... Key Responsibilities + Responsible for strategic and operational regulatory input and support for cross functional ( CMC… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- …have:** + Minimum Bachelor's Degree. Advanced life science degree or certification in Regulatory Affairs Sciences preferred. + Minimum of 5 years' experience in ... Regeneron is seeking a Manager to join the Regulatory Intelligence...or more of these additional areas is a plus: CMC /Mfg., Clinical development and trial execution, Regulatory ,… more
- West Pharmaceutical Services (Exton, PA)
- …Requisition ID: 66496 Date: Aug 14, 2024 Location: Exton, Pennsylvania, US Department: Regulatory Affairs Description: **Who We Are:** At West, we're a dedicated ... Project Management (RPM) role is responsible for management of regulatory affairs projects associated with West's global...IEC 62304, ISO 11608), 21 CFR Part 820 and CMC regulatory requirements. + Experience in medical… more
- Bausch Health (Bridgewater, NJ)
- …facilitates review and approval processes with appropriate cross-functional teams (such as Regulatory Affairs Product Lead, CMC , Graphics, Legal, Quality, ... labeling for accuracy and for other regulatory requirements. + Liaise with Regulatory Affairs members and other cross-functional teams to ensure the accuracy… more
- Rush University Medical Center (Chicago, IL)
- …input to his/her supervisor to identify areas of opportunity within the manager 's scope, escalate risk and resolve barriers. This position will provide direction, ... communicates with Revenue Cycle colleagues, study teams, patients, Office of Research Affairs , IRB, RUMC Compliance, and all partners in the Research Continuum. *… more
- Taiho Oncology (Princeton, NJ)
- …(Clinical Studies, CROs, Central Lab, IRT, IRBs, Wearables, Investigators sites, Medical Affairs , HEOR, CMC and other related ancillary providers etc.) sourcing ... Sr. Manager , Outsourcing & Vendor Management Princeton, NJ, USA...negotiation, and project award. + Ensures compliance with all regulatory and reporting requirements related to Supplier Diversity and… more
- Novo Nordisk (Lexington, MA)
- …(statistics, pharmacometrics), Research and Early Development, Global Translation, Global Medical Affairs , Global Safety (GS), Bioanalysis, CMC and occasionally ... clinical pharmacology aspects at internal and external meetings with eg regulatory authorities /advisory board meetings / governance boards / investigator meetings… more
- BD (Becton, Dickinson and Company) (Warwick, RI)
- …**:** The Senior Quality Engineer works closely with shared functions (eg Regulatory Affairs , Designated Complaint Handling Unit (DCHU), Sterility Assurance, ... Sales, Marketing, Operations, and Finance. The Senior Quality Engineer interacts with Regulatory Affairs regarding new regulations and standards as they apply… more
- Takeda Pharmaceuticals (Boston, MA)
- …QUALIFICATIONS/REQUIREMENTS** + Previous drug development experience is preferred (eg Medical Affairs , Clinical Research, Regulatory , CMC , or other ... experience required + 5 to 7 years experience as a project manager leading complex pharmaceutical projects in a multi-disciplinary, global environment + Minimum… more
