- 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… more
- 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 ... particular focus on rest of world (ROW, ex-US/EU) initial marketing applications. As a Manager , CMC Regulatory Sciences , a typical day might include the… more
- Teva Pharmaceuticals (West Chester, PA)
- …for maintaining and updating CMC sections of submissions for assigned products. As Manager CMC Regulatory Affairs you will also be responsible for ... Manager , CMC Regulatory Affairs... Manager , CMC Regulatory Affairs - Remote OR...(MS/PhD in pharmacy, biology, chemistry, pharmacology or related life science , MBA, or MD) + Minimum 7 years of… more
- Regeneron Pharmaceuticals (Troy, NY)
- We are currently looking to fill a Commercial Post Approval CMC Regulatory Sciences Associate Manager position responsible for providing Chemistry, ... global regulatory authorities. + Contributing to developing CMC regulatory strategy. This role may be...device, including some supervisory and/or leadership experience. + Associate Manager : Requires 6+ years of relevant experience + … more
- Pfizer (Andover, MA)
- …Sciences , Business Units, etc. + Serve as a Global Regulatory Sciences Chemistry Manufacturing and Controls ( CMC ) strategist and project leader, providing ... pending registrations and respond to queries. As a Senior Manager , your advanced knowledge of the principles and concepts... Chemistry Manufacturing and Controls ( CMC ) or regulatory expertise in pharmaceutical science development and/or… more
- Merck (Rahway, NJ)
- …analysis, and interpretation posed by scientists, Contract Research Organizations, and/or regulatory agencies. + May participate with manager in discussions ... **Job Description** In BARDS (Biostatistics and Research Decision Sciences ), a distinguished department within our company's renowned Research and Development… more
- Gilead Sciences, Inc. (Foster City, CA)
- …help create possible, together. **Job Description** **Key Responsibilities** Senior Manager , Global External Manufacturing Biologics supports uninterrupted supply of ... external contract manufacturing network, while ensuring compliance with cGMP, regulatory requirements, and environmental, health, and safety legislations. This… more
- Gilead Sciences, Inc. (Foster City, CA)
- …and help create possible, together. **Job Description** **Key Responsibilities** Manager , Global External Manufacturing Oral-Solid Dosage (OSD) works to ensure ... external contract manufacturing network, while ensuring compliance with cGMP, regulatory requirements, and environmental, health, and safety legislations. This… more
- Gilead Sciences, Inc. (Foster City, CA)
- …with Small Molecule Drug Substance Development, Small Molecule Drug Product Development, CMC Regulatory Affairs, Quality Control and Manufacturing Operations by ... supporting process chemistry and formulation development, and generating data for regulatory submissions. The Principal Scientist will be a technical leader in… more
- Ascendis Pharma (Palo Alto, CA)
- …to all aspects of the business, from drug development to marketing. The Manager , Regulatory Affairs will be responsible for supporting and developing global ... Regulatory Affairs. Key Responsibilities + Responsible for strategic and operational regulatory input and support for cross functional ( CMC , non-clinical and… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …well as other research areas centered around rare diseases and immune disorders. **Summary** The Regulatory Data Manager will be a key member of the Global ... medical needs of people globally by leveraging our world-class science and technology. With more than 100 years of...Regulatory Affairs (GRA) Process Excellence function, responsible for driving… more
- CSL Behring (King Of Prussia, PA)
- …used to treat serious and often rare conditions. Could you be our next Senior Manager of Regional Regulatory Affairs? This position is located in our King of ... relationships with regional health authorities and collaborating with respective GRA Global Regulatory Leads (GRLs) (Global Product Strategy or CMC ) and team… more
- Taiho Oncology (Princeton, NJ)
- …Liaises with CMOs to ensure methods are developed and qualified to meet regulatory requirements, interacts with QA/ Regulatory / CMC to set specifications, and ... Sr. Manager , Analytical Development Princeton, NJ, USA Req #362...and each other. Together, we are working on cutting-edge science and growing our portfolio and pipeline across a… more
- University of Colorado (Aurora, CO)
- QA Senior Manager - 33670 University Staff **Description** **University of Colorado Anschutz Medical Campus** **Department: Gates Biomanufacturing Center** **Job ... Title: QA Senior Manager ** **Position #: 00803572 - Requisition #:33670** **Job Summary:**...+ Serve as the QA point of contact in CMC and Process Development and direct QA functional areas… more
- WuXi AppTec (Middletown, DE)
- …needs in TIDES drug development from discovery through clinical to commercial. Moreover, our Regulatory Affairs CMC team is experienced in preparing CMC ... drug). We greatly simplify the TIDES drug development by providing all discovery, CMC development and the entire manufacturing supply chain under one roof. With over… more
- Integra LifeSciences (Plainsboro, NJ)
- …making headway to help improve outcomes. **SUMMARY** The Reliability Engineering Manager oversees a multidisciplinary team responsible for the technical and ... GMP manufacturing of medical devices at the Collagen Manufacturing Center ( CMC ). This role is also responsible for multidisciplinary process selection, optimization… more
- BeiGene (San Mateo, CA)
- **General Description:** The Associate Manager (AM), Regulatory Information Management (RIM) will serve as the global knowledge-center for the Regulatory ... the BeiGene RIM system as the authoritative source for regulatory data. The AM will ensure compliance with all...data standards. This role which reporting to the Senior Manager RIMT is a critical member of the RIM… more
- Astellas Pharma (Sanford, NC)
- …to: Manufacturing, MSAT, Process Engineering, Process Development, Quality Assurance, Process Sciences , Regulatory , CMC teams, Facilities, Validation, Supply ... more than 70 countries around the world. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their… more
- Bausch Health (Petaluma, CA)
- …+ Should have good working knowledge of all areas of development - including CMC , non-clinical, clinical, project management and regulatory functions + Will be ... + In concert with the Core Team, the Project Manager will develop, maintain, and drive the project timelines...expected to manage all milestone regulatory filings for development programs from pre-IND briefing packages… more
- BeiGene (Emeryville, CA)
- …provide a high service level to internal stakeholders (eg Commercial Marketing, Regulatory , Quality, CMC , Planning and Logistics). . Lead commercial packaging ... engineering and chemistry principles coupled with advanced and diverse materials science understanding to evaluate, design, qualify and implement packaging designs… more