- Regeneron Pharmaceuticals (Troy, NY)
- Regeneron is currently looking for a Manager for our CMC Regulatory Sciences team. We are seeking a highly motivated and experienced regulatory professional ... rest of world (ROW, ex-US/EU) initial marketing applications. As a Manager, CMC Regulatory Sciences, a typical day might include the following: + Develop… more
- J&J Family of Companies (Raritan, NJ)
- Manager Global CMC Regulatory Affairs - 2406185933W **Description** Johnson & Johnson Innovative Medicine is recruiting for a Manager, CMC Regulatory ... to these teams and global regulatory teams. + Ensures that CMC regulatory strategy is aligned with strategies of global regulatory Affairs, therapeutic… more
- 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
- Regeneron Pharmaceuticals (Troy, NY)
- The Project Specialist, CMC Regulatory Sciences is responsible for coordinating and supporting the deliverables and projects of the CMC Regulatory ... authorities are incorporated into the business. As a Project Specialist, CMC Regulatory Sciences, a typical day might include the following: + Uses project… 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 (Basking Ridge, NJ)
- …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
- Lilly (Indianapolis, IN)
- … CMC technical knowledge and regulatory science expertise to drive regulatory CMC strategies and develop submissions for clinical trials and marketing ... synthetic molecule CMC drug development science(s). + Knowledge of global CMC regulatory requirements and guidelines for conducting clinical trials and… 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
- 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
- Regeneron Pharmaceuticals (Troy, NY)
- The Director of CMC Industry and Regulatory Intelligence is responsible for enabling chemistry manufacturing and controls ( CMC ) quality and compliance ... all CMC operations across Regeneron. As a Director of CMC Industry and Regulatory Intelligence, a typical day might include the following + Provides… 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
- Takeda Pharmaceuticals (Boston, MA)
- …team, develop as well as oversee development (including updates) and communication of proactive regulatory CMC strategies to global CMC regulatory teams ... capital and financial decisions. + Provides leadership of GRA CMC Biologics & ATMP regulatory team and in conjunction with direct reports, manages resources,… more
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