Manager Regulatory Affairs Job Vacancies in Palghar

Roles and Responsibilities :Regulatory/ DMFAsking for necessary technical inputs from various departments in the Factories and doing its assessment.To give the necessary technical inputs required by the respective government departments (FDA, CDSCO ) under the guidance of the Head RegulatoryCompilation, review and submission of DMF (Drug master file) to Regulatory & ROW markets as per the given guidelines.To keep DMF files active as per the agency requirements.Revision/Renewal of CEP.Compilation & submission of Applicants part DMF (Drug master file) & QOS for customers.Compilation & Submission of RP DMF for authorities.Submissions of DMF Annual report to USFDASubmissions of DMF amendments to USFDAReply to the queries raised by respective authoritiesCustomer ServicingResponsible to address different questions and queries (technical) in the given time frame for customersTo get the necessary information from QA, QC for compilation and onward submission to regulatory authorities and customers as response to their queriesTo evaluate the technical agreements /CDA to be signed with the customers as on basis.Review of vendor questionnaire within the required timeframe along with supporting documents to customers and maintaining the record for the same.Preparation of the certificate of suitability for various customersPreparation/review of different kinds of declarations as per customer requirementsReview of change control, customer notification/intimationKeeping the track of customer notification/Intimation and response to the various queries raised by various customers & Log Maintenance Preparation of LOAs