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Regulatory Affairs Specialist

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Job#: 21GPH16

Job Description:
Global Pharma Tek, LLC has job openings for Regulatory Affairs Specialist. Jobs located in Edison, NJ and various unanticipated locations throughout the U.S. Develop detailed strategies and perform activities necessary to secure domestic and foreign regulatory clearance, approval, and registration of products. Communicate submission requirements to product development and process improvement teams. Serve as an internal consultant to project teams, providing Regulatory Affairs feedback and guidance on new product development, design changes, as well as other proposed changes that may require regulatory inputs. Maintain annual facility registrations and product listings as appropriate. Develop competitive regulatory strategies and execute on filing submissions to regulatory authorities and ensure the maintenance of regulatory files. Travel/relocate to various unanticipated locations throughout the U.S. for long and short term assignments at client sites. Requires Master’s degree or foreign equivalent in Regulatory Affairs, Information Assurance, Chemistry, Engineering (any), Pharmacology, Life Sciences, or related. Offered salary $91,000.00 P/Y. Mail resume with cover letter to Global Pharma Tek, LLC, 2025 Lincoln Highway, Suite 225A, Edison, NJ 08817; Job 21GPH16; EOE