Job Opening Drug Regulatory Affairs (DRA) & Business Development Coordinator

Qualification: B. Pharm / M. Pharm

Experience: 1–4 years

Job Location: Noida, Uttar Pradesh

Employment Type: Full-Time

Office Timings: 09:30 AM to 05:30 PM

Weekly Off: 2nd & 4th Saturday and every Sunday

Department

Drug Regulatory Affairs (DRA) & Business Development

Job Responsibilities

1. Review and verify product artwork, QA documents, administrative documents, and other regulatory documents received from manufacturing sites.
2. Prepare and compile regulatory dossiers in CTD, ACTD, eCTD, and country-specific formats.
3. Coordinate and follow up with manufacturing sites for timely arrangement of required documents, samples, certificates, and other regulatory information.
4. Coordinate third-party testing/analysis of product samples and review and verify analytical results.
5. Coordinate and conduct finished goods inspection prior to dispatch at manufacturing/warehouse sites, as required.
6. Support and coordinate GMP audits, regulatory inspections, and compliance verification of manufacturing facilities.
7. Prepare, compile, review, and submit tender-related regulatory and technical documents.
8. Track and manage regulatory dossier submissions, approvals, renewals, variations,



and other post-registration activities.
9. Provide support for regulatory affairs activities and cross-functional projects as required.
10. Conduct export market analysis, assess market potential, and support regulatory and commercial strategy planning for new markets.
11. Coordinate with the Business Development, Regulatory, QA, Manufacturing, and other cross-functional teams for product registration, market launch, and commercial activities.
12. Maintain appropriate regulatory trackers, submission records, correspondence, and status reports to ensure timely completion of assigned activities.

Key Skills & Competencies

- Good understanding of pharmaceutical regulatory affairs and dossier requirements.
- Knowledge of CTD/ACTD/eCTD and country-specific regulatory submissions.
- Good documentation and review skills.
- Strong follow-up, coordination, and communication skills.
- Ability to coordinate effectively with manufacturing sites and cross-functional teams.
- Valuable analytical and problem-solving abilities.
- Proficiency in MS Office (Word, Excel, PowerPoint).
- Willingness to travel to manufacturing sites, warehouses, and for regulatory/business requirements, as applicable.

📌 Walk-in || Drug Regulatory Affairs (DRA) & Business Development Coordinator (Gautam Buddh Nagar)
🏢 Devats India
📍 Gautam Buddh Nagar