: 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 current 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 recent 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