Regulatory Affairs Executive

Job Description

Position : Regulatory Affairs Executive Department : Regulatory Affairs Location : Ahmedabad Key Responsibilities Write, analyze, and edit technical documents to support country specific regulatory submissions and compile submissions in a format consistent with applicable guidance documents Work with other departments and communicate the submission requirements when documents are needed for regulatory submission. eCTD Compilation Annual Report Writing for USFDA Product Transfer Support Maintain regulatory files. Maintain and update regulatory authorizations. Assure that appropriate maintenance of registrations occurs including renewals, listings, site registrations, supplements for changes (PAC) and annual reports. Support approval in other regions as required. Assist in preparing response to regulatory authoritys questions within assigned timelines. Stay abreast of regulatory procedures and changes in regulatory climate. Review and create product labels and review promotional material for compliance with applicable regulations and technical standards. Support external regulatory agency audits, providing regulatory input to minimize potential for findings of non-compliance. Other duties as assigned. Qualifications & experience required B. Pharm or M. Pharm / Graduate degree in life science background. Note: Immediate Joiners will be preferred.