- 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
- Insmed Incorporated (Bridgewater, NJ)
- …understanding of basic and intermediate statistical tests.Good understanding of GxP, CMC , ICH and compendial (USP/EP/JP) regulatory requirements.Proficient in ... in the biopharma industry, come to Insmed to accelerate your career. RecognitionsNamed Science 's Top Employer in 2021, 2022, and 2023Insmed is dedicated to creating… more
- Novo Nordisk Inc. (Boulder, CO)
- …new laboratory completed in 2021 to support analytical and process development, the CMC team works alongside Quality, Regulatory , Technical Operations and RNAi ... the Department The Boulder Site is home to the specialized technical operations/ CMC team for oligonucleotides and RNAi therapeutics, continuing its legacy as the… 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 Legal ... 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
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …generation, design and leadership of clinical development plans, and addressing all regulatory , drug and patient safety, data, CMC , IP, patient selection, ... medical needs of people globally by leveraging our world-class science and technology. With more than 100 years of...competitive, asset strategy and execution to ultimately achieve global regulatory filings and ensure wide access of the compound.… 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… 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
- Charles River Laboratories (Rockville, MD)
- Senior Project Manager CMC Req ID #: 223438...across the globe. Whether your background is in life sciences , finance, IT, sales or another area, your skills ... you can feel passionate about. **Job Summary** The Senior CMC Project Manager leads project execution after...degree (BA/BS) or equivalent in project management, business, biological sciences , or related discipline with Life Sciences … more
- Gilead Sciences, Inc. (Foster City, CA)
- …committed to the rapid delivery of safe life-changing therapies. **Job Summary:** Gilead Sciences seeks a Sr. Manager , Quality Assurance, in the Pharmaceutical ... the product/program, and ensures visibility and communication of key project timelines and CMC milestones + Acts in a project manager capacity to ensure:,… 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
- Takeda Pharmaceuticals (Boston, MA)
- …knowledge. **Job Description** Takeda Development Center Americas, Inc. is seeking a Manager , Global Regulatory Affairs, Marketed Products in Cambridge, MA with ... -Analyze the regulatory pathway and history (including competitive regulatory analysis) by researching pre-clinical, clinical, CMC and post-marketing… 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
- ThermoFisher Scientific (High Point, NC)
- …contract manufacturing activities (CMO) and development of mainly generics OTC products. The regulatory manager will lead site regulatory activities related. ... career as part of the world leader in serving science . As part of the Thermo Fisher Scientific team,...experience in the pharmaceutical industry + Strong knowledge of regulatory dossier content, full applications, and CMC … more
- Intra-Cellular Therapies, Inc (New York, NY)
- …with projects in preclinical development stage through Phase III. We celebrate science , welcome curiosity, expect collaboration and demand integrity and respect in ... all we do, create and deliver. As part of the CMC (Chemistry, Manufacturing and Controls) team of ITCI, **the** **Senior Manager , Formulation Development** will… more
- Bristol Myers Squibb (Summit, NJ)
- …drug product formulation and process development principles. + Experienced in building the CMC dossier for regulatory submissions as an author/reviewer. + Prior ... Product Development (DPD)** Our Drug Product Development team is committed to CMC design, development, and commercialization of innovative drug products to improve… more
