Job Description

Roles and Responsibilities Review of technical regulatory documents for drug substance and drug products Compilation of CMC data for submission to regulatory authorities Review and approval of master documents for CMC segments Preparation and review of annual reports, amendments, supplements etc. Assist with CMC responses to regulatory authorities queries during development, registration, and product lifecycle. Evaluation and co-ordination of change controls Liaison with various departments like R&D, QC, QA, Production, stability departments for obtaining documents. Prepare response to regulatory deficiencies letters according to US regulatory requirements. Desired Candidate Profile The candidate should have adequate knowledge in regulatory affairs (Injectable or Ophthalmic formulations) for US market. He/ She should have 3 - 5 years of experience with B. Pharm./ M. Pharm./ M. Sc. as a educational qualification. Candidate should possess excellent verbal and communicational skills.