Sr. Executive Drug Regulatory Affairs

Ridhi Consulting Services; New Delhi; On-site; INR 450,000 - 750,000; Full time

Job summary

Ridhi Consulting Services in Delhi seeks an Executive/Sr. Executive to lead drug regulatory affairs with extensive experience. You will compile and review registration dossiers per CTD/ACTD for ASEAN, Africa, LATAM, GCC and CIS regions.

The role requires deep knowledge of regulatory submissions, including Module 1 and Module 3, plus handling CDSCO and State FDA licenses, WHO-GMP, and related certifications. Strong communication with overseas teams is essential.

Qualifications

• 25 years of regulatory affairs experience in the pharmaceutical sector.
• Experience compiling and reviewing registration dossiers per CTD/ACTD for multiple markets.
• Strong knowledge of CDSCO and WHO-GMP licensing processes.

Responsibilities

• Dossier preparation and submission for global markets.
• Review of DMF, BMR, BPR, and analytical reports.
• Coordinate with overseas regulatory teams for timely filings.
• Handle applications to CDSCO and State FDA, including licenses and WHO-GMP.
• Respond to deficiency letters within agreed timelines.

Skills

Regulatory affairs

Dossier submission

Global registrations

Education

B.Pharm / M.Pharm / M.Sc. in Life Sciences

Tools

CTD/ACTD knowledge

ICH guidelines

DMF/BE/ BPR review

Job description

Job Description: 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 new 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.