Key Responsibilities

- Prepare, review, and compile pharmaceutical product registration dossiers (CTD, ACTD, and country-specific formats).
- Handle regulatory submissions, product registrations, renewals, and variations for international markets.
- Prepare and verify product inserts, SmPCs, PILs, specifications, COAs, and regulatory documentation.
- Ensure consistency across product compositions, artwork, dossiers, and supporting documents.
- Coordinate with manufacturers, QA/QC teams, and international distributors for regulatory requirements.
- Respond to regulatory queries and ensure timely submission of documentation.
- Maintain regulatory trackers and monitor country-specific registration requirements.

Requirements





- Minimum 2 years of experience in Pharmaceutical Regulatory Affairs (DRA).
- Strong knowledge of CTD/ACTD dossier preparation and international regulatory guidelines.
- Experience in pharmaceutical export registrations preferred.
- Good understanding of pharmaceutical documentation, labeling, and compliance.
- Robust attention to detail and ability to handle multiple projects independently.
- Proficiency in MS Office and regulatory documentation.

Preferred: Experience with African, CIS, or Southeast Asian pharmaceutical markets.

Pay: From ₹20,000.00 per month

Work Location: In person

📌 Drug Regulatory Affairs (DRA) Executive (Noida)
🏢 CarpeDiem Healthcare
📍 Noida