Executive/Sr. Executive - RA-API

Job Title: Regulatory Affairs -API

Experience: 3-5 Yrs

Location: Dholka Ahmedabad

Designation: Executive/Sr. Executive

Education: M.sc (Chemistry)

• Compilation, Review and submission of Drug Master file to global markets. Annual report to registered DMF.
• Handling of regulatory queries/deficiencies across global markets.
• Submission of annual submission/amendment of filed DMF for global markets including US,EU,Canada etc.
• Creation and maintenance of regulatory database for all the submissions. Review of functional documents such as specifications/Test Procedures/Product development reports/stability protocols etc. Establish co-ordination with other departments like QA/QC,R&D, Marketing and purchase for ensuring the filings and query response within time.
• Hands on experience in eCTD compilation and submission to global regulatory authorities using portal.
• Submission of various original documents for notarization, chamberization and legalization, which is part of registration. Arrangement of COPP's (Certificate of pharmaceuticals product),samples, Impurities, Reference standards as per MOH/Customer requirement.
• Compilation of Applicants parts, questionnaires,LOA and other declarations to customer existing/New customers. Any other assignments as specified by the reporting authority from time to time.

Interested candidate can share there cv at shardulsinh.k@cadilapharma.com