Senior Executive, Regulatory Affairs - API

Job Summary

Preparation of original DMF, amendments, Annual reports and Review of adequacy of documents for submission

Job Responsibilities

• Compilation, review and submission of various Drug master files for US, EU, TGA, Canada and other markets as per respective regulatory guidelines and checklist
• Preparation of Original Drug Master File for regulatory submission.
• Preparation of Amendments and annual reports for regulatory submission.
• Co-ordinate with technology transfer sites for RA support for DMF and dossiers.
• Execution of regulatory activities through various tools like, Docubridge, Livelink, RIMS, Trackwise, label bridge etc.
• Compilation of Deficiency responses for regulatory submission.
• Review of draft RSM, MPDR and GTI discussion in-line to process and current requirements, and against the screening study data for DMF submission.
• Change control assessment for regulatory impact before implementation.
• Risk assessment of DMF’s from various API manufacturing to support in-house ANDA filing.
• Supporting for Business development related activities (Third party customers)
• Interacting with supporting departments like R&D, QC, QA, production and AR&D etc. on issues related to RA for DMF submissions and deficiency responses.
• Administrative and local licensing activities involved in regulatory affairs.
• All other relevant duties as assigned

Job Requirements

• Education
  • Master’s degree in Science/Pharmacy
  • Knowledge, Skills and Abilities
  • Good command over MS-Office: Word, Power Point, Excel etc.
  • Interacting with supporting departments like R&D, QC, QA, production and AR&D etc. on issues related to RA for DMF submissions and deficiency responses.
• Experience
  • 6-8 years’ experience in Regulatory Affairs