Senior Executive, Reg Affairs-ARPL-RA AR

Job Summary

Preparation and review of original injectable product submissions, amendments, and annual reports to ensure completeness, sterility compliance, and regulatory adequacy of all documentation.

Job Responsibilities

Compilation, review and submission of ANDA/NDA (505b2)/ANDS/NDS for US, Canada markets for Injectables and Ophthalmic
•    Review and finalization of submissions as per respective regulatory guidelines and checklist
•    Compilation and review of sterility assurance package (section 32P35)
•    Compilation of Deficiency responses for regulatory submission.
•    Compilation, review and submission of post approval submissions (PAS/CBE-30/CBE/Supplements/Annual Notifications)
•    Execution of regulatory activities through various tools like, Docubridge, Livelink, RIMS, Trackwise, labelbridge etc.
•    Change control assessment for regulatory impact before implementation.
•    Interacting with supporting departments like R&D, QC, QA, production and AR&D etc. on issues related to RA for New submissions and deficiency responses.
•    Review of all technical documents required for compiling the new drug submissions, post approval submissions and query responses.
•    Relevant communication and follow ups with the respective customers required for compilation, submission and respective query responses.
•    Responsible for eCTD/RIMS activities of submissions
•    Works in a safe manner collaborating as a team member to achieve all outcomes.
•    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 submissions and deficiency responses.
• Experience
  • 5-8 years’ experience in Regulatory Affairs