Executive- Regulatory Affairs

Role & responsibilities

• Preparation & Compilation of dossiers in CTD/ACTD/eCTD formats for ROW countries (ASEAN, GCC, African and other less regulated markets)
• Review of documents for dossier compilation e.g. Product development reports, tech transfer documents, Validations (analytical method validation, Process validations), specifications/STPs, Manufacturing records, Stability data, labeling & pack inserts
• Dossier writing with focus on accuracy, adequacy & completeness of data
• Preparation and review of response to regulatory queries raised by agency within the stipulated time-frame
• To collaborate with internal departments e.g. Production, QA, QC and other concerned departments to compile quality documents timely, as per country specific requirements
• Preparation of Post Approval Changes/variations documents
• Review of artworks & preparation of SmPC, Leaflets, labelling part of the dossier
• To keep track of country/product wise registrations & renewals