- 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 ... focus on rest of world (ROW, ex-US/EU) initial marketing applications. As a Manager , CMC Regulatory Sciences, a typical day might include the following: +… more
- BeiGene (San Mateo, CA)
- **General Description:** + The Manager , Regulatory Affairs CMC , is responsible for developing and implementing global regulatory CMC strategies to ... and in coordination with key internal stakeholders. This position will manage regulatory CMC aspects of compounds (large molecules) through all phases… more
- Astellas Pharma (Westborough, MA)
- ** Regulatory Manager , Regulatory Affairs - CMC (Gene Therapy)** Do you want to be part of an inclusive team that works to develop innovative therapies ... remote work are encouraged to apply. **Purpose and Scope:** Responsible for developing regulatory CMC strategy for assigned projects. Identifies and collects … more
- Regeneron Pharmaceuticals (Tarrytown, NY)
- …this role, a typical day might include the following:** + Responsible for CMC /CP product development activities to lead the regulatory standpoint during early ... for program-specific discussions, connect the dots across IOPS, proactively identify CMC /CP regulatory issues and develop appropriate strategies to mitigate… more
- Gilead Sciences, Inc. (Foster City, CA)
- …35 countries worldwide, with headquarters in Foster City, California **About the role:** The CMC Regulatory Affairs Sr. Manager at Gilead is responsible for ... providing strategic direction, operational support, and technical expertise for CMC regulatory activities and related regulatory initiatives.… more
- Takeda Pharmaceuticals (Columbus, OH)
- …**Job Description** **About the role:** We are seeking a highly motivated and qualified regulatory CMC professional for the Global Regulatory Affairs CMC ... CMC & Device organization is responsible for global CMC regulatory strategies and activities for the...market launch and product lifecycle management. The Strategist (Sr Manager ) works in a highly highly matrixed, global product… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …with 8-10 years pharmaceutical industry experience with 4+ years direct or related CMC regulatory experience or + PhD. with 6-8 years pharmaceutical industry ... Leads US FDA/EU EMA interactions with support from higher-level manager . + ** Regulatory Knowledge:** Demonstrates expert knowledge...experience and 4+ years direct or related CMC regulatory experience + Successful track record… more
- Frontier Medicines (South San Francisco, CA)
- Join Frontier Medicines on an exciting journey as our newest Senior Manager /Associate Director in CMC Development, located at either our Boston or South San ... of our team, reporting directly to the Head of CMC , you'll play an integral role in advancing our...thorough understanding of ICH guidelines, GLP/GMP manufacturing, and related regulatory requirements is required + Ability to travel domestically… more
- UTMB Health (Kenedy, TX)
- CMC Medication Aide Student Trainee - Connally Unit **Kenedy, Texas, United States** **New** Allied Health UTMB Health Requisition # 2403674 The mission of ... + Assists with patient activities and care as assigned by the nurse manager /designee as indicated by the patient's plan of care. Maintains patient care areas… more
- UTMB Health (Friendswood, TX)
- Mgr, Imaging Services- CMC -Baybrook/Stafford **Friendswood, Texas, United States** Allied Health UTMB Health Requisition # 2403238 The mission of Correctional Managed ... and the Texas Juvenile Justice Department (TJJD). **_JOB SUMMARY:_** The Imaging Services Manager is an experienced imaging manager with operational scope over a… 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
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- Regeneron is seeking a Manager to join the Regulatory Intelligence Group! **In this role, a typical day might include:** The Regulatory Intelligence ... from assigned departments or functions within the organization's GxP framework. The Regulatory Intelligence Manager will also facilitate processes to hold… more
- BeiGene (San Mateo, CA)
- …for regulatory technology and submissions (eg, eCTD, IDMP, SPOR/DADI, PQ- CMC , SPL) and coordinate impact assessment on systems and relevant data elements ... RIM function at BeiGene drives strategies, implementation and management of regulatory technology and information, by collaborating with cross functional teams (RA,… more
- Takeda Pharmaceuticals (Boston, MA)
- …development functions. + Prepare and coordinate completion of technology transfer documentation, CMC sections of regulatory documents, or validation plans and ... technical objectives (project and scientific related) with input from manager as needed. + Identify and recommend vendors as...Ability to design and direct analytical strategy to meet CMC project objectives. + Experience in preparing regulatory… more
- West Pharmaceutical Services (Exton, PA)
- …ISO 14971, ISO 15223, IEC 62304, ISO 11608), 21 CFR Part 820 and CMC regulatory requirements. + Experience in medical device life-cycle Management, including ... guidance documents and current state-of-art standards/regulations. + Collaborate with regulatory lead(s), cross-functional project manager (s) and SMEs (Subject… more
- Actalent (Gaithersburg, MD)
- …and maintains strong working relationships with colleagues in Research and Development, Regulatory CMC , Quality as well as alliance partner counterparts, as ... manufacturing investigations, method troubleshooting, method validation/transfer, and authoring of CMC analytical sections in support of regulatory … more
- Lilly (Indianapolis, IN)
- …teams towards an established timeline that meets customer requirements and supports CMC and Regulatory timelines + Responsible for Tech Transfer Plans/Reports ... of new device and packaged products to support Chemistry, Manufacturing, and Control ( CMC ) agendas and timelines. This role serves as the conduit between development… more
- BeiGene (Emeryville, CA)
- **General Description:** Sr. Manager /Associate Director, Supply Chain CMO Management & PM will own and enable the communication, coordinate tasks between the ... with Contract Manufacturers (CMO) + In partnership with Quality, CMC , Procurement, ensures that innovation, manufacturing performance, cost objectives and… more
- LA Care Health Plan (Los Angeles, CA)
- Product Solutions Manager III Job Category: Administrative, HR, Business Professionals Department: Medicare Product Location: Los Angeles, CA, US, 90017 Position ... safety net required to achieve that purpose. Job Summary The Product Solutions Manager III is responsible for assisting the product leadership team within the… more
- Bausch Health (Bridgewater, NJ)
- …facilitates review and approval processes with appropriate cross-functional teams (such as Regulatory Affairs Product Lead, CMC , Graphics, Legal, Quality, Supply ... drive our collective progress and impact. **OBJECTIVES/PURPOSE OF JOB** Labeling Manager is responsible for leading labeling artwork projects for the development… more