Executive - Pharma Regulatory Affairs

EXPERIENCE: 5+ YEAR IN REGULATORY AFFAIRS IN A PHARMACEUTICAL INDUSTRY QUALIFICATIONS : B.PHARM/M.PHARM JOB DESCRIPTION: Compiling & documentation of wide range of data and information of Regulatory Affairs. Knowledge of regulatory guidelines of various countries. Information of regulatory compliances, knowledge of various ICH guidelines and cGMP guidelines. Ensuring preparation of documentation according to the requirements of MOH of the concerned country for various dosage form. Monitoring and checking of registration and re-registration dossiers of formulations & EHGC. Sorting out technical queries received from agents and health authorities of respective countries for registration of products. Co-ordination with Quality Assurance, Quality Control, R&D, packing, Production for technical data from different manufacture. Checking for artwork development of packing material for product. Maintain the registration certificate and maintain the records of registered products for renewal of registration. Upgrading knowledge in line with ever changing regulatory requirements. Compilation of documents for company registration and inspection by overseas regulatory authorities. Furnishing the scientific responses to deficiency queries received from various regulatory bodies. Application of Manufacturing Licenses for new products and COPP Review of BMR, PDR, Process Validation Data, Validation of Analytical Procedure, stability data, dissolution data, specifications etc. Checking of Artwork as per the guidelines Have acquaintance with CTD filling to various regulatory bodies. Co-ordinate with various departments lime QA, QC, Production, F&D, Artwork development department for collecting and processing various technical documents required for dossier compilation. Coordinate with Third parties for procuring the documents required for registration as per the requirement. Compilation of dossier for Formulations Responsible for notarization and legalization of administrative documents , from Embassy as per country requirement. Document preparation for FDCA application like Product Permission, Free Sale Certificate, Certificate Of Pharmaceutical Products with or without WHO inclusion, Loan License Manufacturing application, GMP Certificate application, WHO GMP Certificate application, Product inclusion in WHOGMP list, Supervisory Chemist for LLM, Test License application, Product Permission with NOC, Non Standard Quality Certificate application, Query certificate for relevant country guideline as well as customer requirement. Control of online doc mentation according to FDCA reguirement and Freezing process. Good knowledge of Drugs and Cosmetics Acts. Job Type: Full-time Pay: ₹30,000.00 - ₹40,000.00 per month Work Location: In person Benefits: Provident Fund Schedule: Day shift Experience: total work: 1 year (Preferred) Job Types: Full-time, Permanent Pay: ₹30,000.00 - ₹40,000.00 per month Benefits: Health insurance Provident Fund Schedule: Day shift Work Location: In person Job Types: Full-time, Permanent Pay: ₹35,000.00 - ₹48,679.31 per month Benefits: Cell phone reimbursement Health insurance Provident Fund Schedule: Day shift Work Location: In person