Executive- Regulatory Affairs

Torque Pharmaceuticals; Sahibzada Ajit Singh Nagar; On-site; INR 600,000 - 1,200,000; Full time

Job summary

Torque Pharmaceuticals is looking for a Regulatory Dossier Writer to prepare and compile CTD/ACTD/eCTD dossiers for ROW markets including ASEAN, GCC, Africa and others.

The role involves reviewing development reports, validation data, specifications, manufacturing records, and labeling materials to ensure accuracy and completeness, while coordinating with Production, QA, QC to meet country-specific registration requirements and timelines.

Responsibilities

• Preparation and compilation of dossiers in CTD/ACTD/eCTD formats for ROW markets.
• Review documents for dossier compilation such as development reports, tech transfer docs, validations, specifications, manufacturing records, stability data, labeling & pack inserts.
• Dossier writing focusing on accuracy, adequacy and completeness of data.
• Prepare and review responses to regulatory queries within defined timeframes.
• Coordinate with Production, QA, QC to compile quality documents per country requirements.
• Prepare Post Approval Changes/variations documents.
• Review artworks and prepare SmPC, leaflets and labeling sections of the dossier.
• Keep track of country/product registrations and renewals.

Job description

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