Regulatory Affairs Jobs in South Plainfield
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Search Results - Regulatory Affairs Jobs in South Plainfield
Katalyst Healthcares & Life Sciences-South Plainfield
Manage and submit 510(k) submissions and handle communications with the FDA, including pre-submissions.
Coordinate with the team to monitor the progress of certain products submitted by Ostend Regulatory Affairs departments.
Collaborate with business...
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Proclinical Staffing-Bridgewater (NJ), 11 mi from South Plainfield
Associate) Director, US Regulatory Affairs, Advertising & Promotion - Permanent - NJ & MA
Proclinical is seeking an (Associate) Director, Regulatory Affairs, Advertising & Promotion for a global pharmaceutical company with their location in New...
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Katalyst Healthcares & Life Sciences-South Plainfield
pharmaceutical/biotechnology experience in R&D, including at least 5 years of relevant Regulatory Affairs experience (regional and/or global), in early development....
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Katalyst Healthcares & Life Sciences-South Plainfield
Responsibilities:
Animal Health is a Biotechnology Center of Excellence that manufactures, fills, packages, and distributes vaccines for animals.
Prepare new/revised label packaging for regulatory submissions to the USDA and maintain regulatory...
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Katalyst Healthcares & Life Sciences-South Plainfield
Responsibilities:
Lead the development and implementation of submission-ready SDTM datasets listings (not TLFs) in accordance with regulatory requirements (e.g., FDA, EMA, PMDA).
Collaborate with regulatory affairs and quality assurance teams...
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Katalyst Healthcares & Life Sciences-South Plainfield
and validation plans for computer systems used in the healthcare industry.
Collaborate with cross-functional teams, including IT, Quality Assurance, and Regulatory Affairs, to ensure alignment with validation requirements.
Perform risk assessments to identify...
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Phaxis LLC-South Plainfield
Job Purpose:
To direct and administer all Regulatory Affairs, permits, filings and training including Global Compliance. Develop, implement and coordinate activities of quality functions to prevent or eliminate defects in new or existing products...
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Katalyst Healthcares & Life Sciences-South Plainfield
research in concert with senior clinical personnel, in preparation for health authority submissions.
Partners with Regulatory Affairs in developing regulatory strategy and determining requirement for health authority reporting or corrective actions...
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Global Life Science Hub-New Brunswick, 7 mi from South Plainfield
and infectious diseases, this company has made significant strides in developing both small molecule and biological drug candidates.
As the company transitions into a full commercial organization, they seek a Vice President of Regulatory Affairs to take...
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Katalyst Healthcares & Life Sciences-Rahway, 7 mi from South Plainfield
and define regulatory impact of product changes in global markets.
Review and approve labeling, training, promotional, and advertising material.
Maintenance of Regulatory Affairs product files and ensure compliance with regulatory requirements.
Ensure...
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