- 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
- Aequor (Thousand Oaks, CA)
- …small molecule development and commercial lifecycle maintenance, product stability programs, CMC regulatory filings, risk assessment, and Quality Management ... Manager is requesting candidates college GPA in the...regulatory filing sections and RTQs? Provide expertise in science and risk-based evaluation of complex process and product… more
- Merck & Co. (North Wales, PA)
- …integrating strategic and tactical input from diverse disciplines (eg, clinical, regulatory , market access, manufacturing, CMC , commercial, and other areas) ... Description: Senior Specialist, Project Management- Drug Development The Senior Specialist, Project Manager is a core member of Early Drug Development and/or Late… 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
- Bristol Myers Squibb (Princeton, NJ)
- …(including participating / leading HA meetings); &/or post-approval submissions. In this role, the CMC Regulatory Manager will serve as the primary interface ... a product's lifecycle. Members of the organization develop global regulatory CMC strategies and partner with key...Sciences (GRS) & Global Product Supply (GPS) The GRS- CMC senior manager will assess Manufacturing Change… 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
- Actalent (Lexington, MA)
- Responsibilities: The Contract Manager / Senior Manager - CMC QC will: * Support the external contract organization activities to fulfill the GMP QC testing ... needs * Provide internal support to CMC Operations to support the development, manufacture, and material...Qualifications: * Bachelor's Degree in Biochemistry, Molecular Biology, Pharmaceutical Sciences or a related Life Science field… 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
- Gilead Sciences, Inc. (Foster City, CA)
- …etc. with minimal guidance. + Leads the planning, logistics, and scheduling for CMC Regulatory Affairs Leadership Team meetings and any other similar leadership ... manage managers calendar's (including Pharmaceutical Development & Manufacturing Leadership Team, CMC Regulatory Affairs Leadership Team OOO calendars) + Assists… 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
- Teva Pharmaceuticals (Parsippany, NJ)
- Manager Regulatory Affairs Date: Jun 14, 2024 Location: Parsippany, United States, New Jersey, 07054 Company: Teva Pharmaceuticals Job Id: 56073 **Who we are** ... and qualifications** + Requires a Bachelor's degree in Pharmacy Administration, Pharmaceutical Science , Regulatory Affairs, or a related field, and 3 years… 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
- Gilead Sciences, Inc. (Santa Monica, CA)
- …Quality Organization. The QA Specialist III will report to the Senior Manager , External Quality. Scope of the External Quality group includes quality oversight ... Technical Operations organization (eg Process and Analytical Development, MSAT, Regulatory , Quality, Manufacturing, and Supply Chain), as well as international… 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
