- Regeneron Pharmaceuticals (Troy, NY)
- The Manager, CMC Regulatory Sciences for Clinical Submissions leads a team that manages the CMC regulatory submission work across multiple clinical ... programs and/or submissions. As a Manager, CMC Regulatory Sciences , a typical day might include the following: + Managing and developing CMC Regulatory … more
- Lilly (Indianapolis, IN)
- …to make life better for people around the world. Organization Overview: The Global CMC Regulatory Associate, Global Regulatory Affairs (GRA) Regulatory ... + Lead CMC submission management process by providing knowledge of CMC regulatory requirements, including a comprehensive knowledge of ICH CTD and… more
- Gilead Sciences, Inc. (Foster City, CA)
- …than 35 countries worldwide, with headquarters in Foster City, California. **Head of CMC Regulatory Affairs - Small Molecules** **KEY RESPONSIBILITIES** The Head ... of CMC Regulatory Affairs - Small Molecules is...of CMC Regulatory Affairs - Small Molecules is responsible for Gilead's...for Gilead's global portfolio of small molecule products in CMC Regulatory Affairs. This position will lead… more
- Teva Pharmaceuticals (West Chester, PA)
- Manager, CMC Regulatory Affairs - West Chester, PA Date: Apr 24, 2024 Location: West Chester, United States, 19380 Company: Teva Pharmaceuticals Job Id: 54241 ... make a difference with. **How you'll spend your day** As Manager, CMC Regulatory Affairs you will be responsible for managing the day-to-day chemistry,… more
- Lilly (Philadelphia, PA)
- …communities through philanthropy and volunteerism. **Position Overview:** The Associate/Manager - CMC Regulatory is responsible for the preparation and delivery ... of high-quality CMC regulatory submissions. This position supports Lilly/Avid diagnostic radiopharmaceutical marketed products globally. **Responsibilities:** +… more
- Regeneron Pharmaceuticals (Rensselaer, NY)
- The CMC Regulatory Affairs Specialist **is responsible for** for a subset of programs at the IOPS facility. Evaluate proposed changes to IOPS documents and ... with regulatory requirements, as necessary. * Tracks and/or completes CMC regulatory commitments for INDs/IMPDs, CTAs, and BLAs/MAAs. * Provides CMC… more
- Boehringer Ingelheim (Ridgefield, CT)
- …is currently seeking a talented and innovative co-op to join our _CMC Regulatory Affairs_ department located at our _Ridgefield_ facility. In this role you will ... _perform regulatory submissions to US NDAs and improve compliance tracking...tracking of marketed products application and improve linkage between regulatory guidelines and internal BI documents_ . As an… more
- Regeneron Pharmaceuticals (Troy, NY)
- …for program-specific discussions, connect the dots across IOPS, proactively identify CMC regulatory issues and suggest appropriate strategies to mitigate ... **In this role, a typical day might include the following:** * Support CMC /Combination product development activities from a regulatory standpoint during early… more
- Editas Medicine (Cambridge, MA)
- …teams in the execution of these submissions. Key Responsibilities: + As the Director, Regulatory CMC , you will be responsible for: + Provide CMC ... Editas regulatory affairs organization by keeping abreast of global CMC regulatory requirements and ensure that project team colleagues and management are… more
- Merck (North Wales, PA)
- …Scientist / Director responsibilities include but are not limited to:** + Serve as a Regulatory CMC Project Lead and provide CMC Regulatory leadership ... measures. + Lead the development, communication, and review of the CMC Regulatory Strategy Document for projects of increasing complexity. + Lead development… more
- Teva Pharmaceuticals (West Chester, PA)
- …SPONSORSHIP IS AVAILABLE** **How you'll spend your day** + Provide accurate and timely CMC regulatory guidance to teams engaged in the development of new ... their applicability to the development teams. + Develop and communicate effective CMC regulatory strategies for development and post marketing submission… more
- Lilly (Indianapolis, IN)
- …that make life better for people around the world. Lilly is looking for regulatory CMC scientists to join us in developing and bringing life-changing new ... technical knowledge and regulatory science expertise to drive regulatory CMC strategies and develop submissions for clinical trials and marketing… more
- Taiho Oncology (Pleasanton, CA)
- …Join our dynamic and expanding mid-size oncology company in the role of Director , Regulatory CMC , reporting directly to Executive Director, Regulatory ... Position Summary: With minimal direction the incumbent manages the global regulatory CMC activities except Asia for all assigned Taiho Oncology Inc., (TOI)… more
- Lilly (Indianapolis, IN)
- … CMC technical knowledge and regulatory science expertise to drive regulatory CMC strategies and develop submissions for marketing authorizations for the ... development strategies and submission content + Makes risk-based decisions on CMC regulatory strategies impacting product submissions across geographies and… more
- J&J Family of Companies (Titusville, NJ)
- Scientist, Regulatory CMC Dossier - Biotherapeutics - 2406181251W **Description** Janssen Research & Development, LLC, a division of Johnson & Johnson's Family ... of Companies, is recruiting for a Scientist, Regulatory CMC Dossier - Biotherapeutics based in Spring House, PA. Remote work options may be considered on a… more
- Takeda Pharmaceuticals (Boston, MA)
- …Affairs Vaccines CMC where you will provide program leadership and develop CMC regulatory strategy for global vaccine programs in various stages of ... professional and timely manner + Stay abreast of current and evolving regulatory CMC requirements, apply this knowledge to assigned projects, and share knowledge… more
- Takeda Pharmaceuticals (Boston, MA)
- …Description** Takeda Development Center Americas, Inc. is seeking a Manager, Global Regulatory Affairs CMC in Cambridge, MA with the following requirements: ... Master's degree in Regulatory Affairs or related field plus 2 years of...of related experience. Prior experience must include: Develop the regulatory submission strategies for products in commercial and development… more
- Regeneron Pharmaceuticals (Troy, NY)
- The CMC Product Quality Regulatory Communications team is hiring! This team is responsible for being the primary Quality representative for product deviation and ... with globalization of Regeneron-owned markets + Interacts with global regulatory authorities in support of the CMC ...global regulatory authorities in support of the CMC activities during Agency inspections. + Support launch readiness… more
- Takeda Pharmaceuticals (Boston, MA)
- … regulatory team in the development and implementation of global CMC regulatory strategies during development commercialization and post approval LCM ... with Global CMC teams and leadership through networks and enable CMC regulatory team's success in meeting goals/objectives. As part of the GRA CMC… more
- Amicus Therapeutics (Marlow, OK)
- …deliverables and ensuring seamless communication. The candidate will ensure all CMC regulatory submissions (such as pre-submission consultation package, review ... for large molecules (Briefing documents, scientific advice, variations etc) . Deliver CMC regulatory content for submissions by engaging with CMC Tech Ops… more
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