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Regulatory Operations Publisher - Contractor
Joulé
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Florham Park, NJ, 07932
... a pharmaceutical regulatory environment, including eCTD publishing of INDs and NDAs. Prior knowledge of CTAs/MAAs a plus. Bachelor’s degree preferred Acquired knowledge of nonclinical, clinical, CMC, DMF, and labeling/SPL submission documents. ... - Jun 04
Associate Director-Quality Assurance (QA-CMC)
Clinical Dynamix
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Jersey City, NJ
... This position will provide CMC quality leadership within the organization and across our Contract Manufacturing Organizations (CMOs) and Contract research labs (CROs). This individual will partner with CMC, Clinical, Regulatory Affairs, and other ... - Jun 02
External Manufacturing Operations Coordinator - CMC
Eliassen Group
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Philadelphia, PA
External Manufacturing Operations Coordinator, CMC Development, Pharma CONTEXT & INITIATIVE DESCRIPTION Our Pharma client is ... Technical Operations, Supply Chain, Quality, Regulatory, Project Management, Analytical Development, and Development groups. ... - Jun 05
GRA CMC Lead, Vaccines
Sanofi
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Scotrun, PA, 18370
... The Chemistry, Manufacturing and Controls (CMC) regulatory team is accountable for the global regulatory strategy for development and marketed products within GRA. The team responsibilities include but are not limited to: global regulatory CMC ... - Jun 05
Regulatory CMC Scientist (US)
UCB
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Atlanta, GA
Make your mark for patients We are looking for a Regulatory CMC Scientist to join us in our Global Regulatory team, based in any of our Brussels (Belgium), Slough (UK), or Atlanta (US) offices. About the role Define the strategy, planning and ... - May 31
Regulatory Compliance Analyst
Amalgamated Life
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Fulton Street, NY, 10604
The Regulatory Compliance Analyst helps to ensure compliance with various state and federal insurance, health, and financial regulations. The duties consist of assisting with the preparation and filing of various regulatory reports, assessments, ... - May 25
Vice President, CMC Technical Development
Scholar Rock
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Cambridge, MA
... Drive CMC planning for global regulatory submissions (INDs, BLAs, MAAs), including technical content for Module 3, comparability strategies, and direct support for regulatory inspections. Functional Oversight: Drug Substance Development: Lead ... - May 13
GRA CMC Lead, Vaccines
Sanofi
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Morristown, NJ, 07960
... Main Responsibilities: Develop CMC regulatory strategies and assess associated risks for development projects and/or registered products (new products or marketed products) in collaboration with all Global Regulatory Affairs entities. Participate in ... - Jun 05
Regulatory Affairs Manager
Planet Pharma
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Bristol, TN, 37621
We are seeking a Regulatory Affairs Manager or Regulatory Affairs Specialist with a strong background in oral solid dose pharmaceuticals and hands-on experience with CMC (Chemistry, Manufacturing & Controls) to support regulatory submissions and ... - Jun 05
Regulatory Affairs Manager
Teva Pharmaceuticals USA Inc.
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West Chester, PA
... seeks a Regulatory Affairs Manager in our West Chester, PA office to: evaluate Change Requests/Change Controls and provide ... Authoring and Reviewing CMC content for use in Health Authority Applications; Understanding and communicating CMC Submission ... - May 31