: Executive / Sr. Executive, Drug Regulatory Affairs (DRA)

Department: Regulatory Affairs

Reports to: DRA Executive /Sr. Executive Regulatory Affair

Experience: 25 years in pharmaceutical regulatory affairs

Qualification: B.Pharm / M.Pharm / M.Sc. (Chemistry, Pharmaceutical Sciences or Life Sciences)

Role summary

Compile and review of registration dossiers in accordance with CTD/ACTD and National guidelines for various global markets including (ASEAN, African, LATAM, GCC and CIS) countries.

Key responsibilities

Dossier preparation and submission

- Specific experience required for ROW markets as ASEAN, African, LATAM, GCC and CIS countries.
- Prepare and critically review regulatory submission including Module1 (Administrative documentation) and Module-3 (Quality section) to ensure full compliance with reginal requirements as well as ICH guidelines.
- Review all technical documents (DMF, Product development Report, BMR, BPR, Analytical Method validation Report, Specification, STP, Stability report, BE study report etc.)




- Compilation of deficiency responses of new product submission and Backlog dossier.
- To review the proposal for any post-approval changes as per the current regulatory guidance.
- To prepare and submit the variation for post approval changes.
- To prepare and submit the Tender documents.
- To review Artwork.
- To communicate and follow up with overseas regulatory team/agent/distributors to ensure timely filing of new submission or variation.
- To review artworks and comments for ongoing commercial supply and products for current launch.

Regulatory approvals and licence

- Handle applications to CDSCO and the State FDA, including manufacturing licence product permissions, COPP, WHO-GMP, Free Sale Certificates, and import/export NOCs.
- Coordinate document legalisation and apostille through embassies and the Chamber of Commerce.

Query handling and lifecycle management

- Respond to deficiency letters and queries from client & health authorities within agreed timelines.

📌 Sr. Executive Drug Regulatory Affairs (New Delhi)
🏢 Ridhi Consulting Services
📍 New Delhi