Executive - Regulatory Affairs

1) Responsible for obtaining approval for new pharmaceutical product 2) Updating legal or regulatory knowledge 3)Compilation of Dossier as per Country requirement i.e. CTD,ACTD or Country Specific. 4)Co-ordination with F & D, BD, QA,QC, Purchase as per relevant Department for Document requirement 5)Handling of Query as per Ministry of Country 6) Reviewing documents required for submissions to ensure they are appropriate for submissions. 7) Maintained RA product files to support compliance with regulatory requirements. 8) Provided regulatory support for currently marketed products as necessary. 9) Maintains status registration of each country per distributor or representative agent of each product line. 10) Variation filing for product as per country guideline 11) Reviewing & checking of Artwork as per country requirement. 12)Responsible for the interpretation, direction, determination, and reporting of regulatory agency requirements. 13) FDA Application : Product Permission, Free Sale Certificate, Certificate of Pharmaceutical Product, Test License, Renewal Manufacturing License for Own & Loan. Pay: ₹300,000.00 - ₹500,000.00 per year **Benefits**: - Health insurance - Provident Fund Schedule: - Day shift Supplemental Pay: - Yearly bonus Work Location: In person