Job Description Regulatory Affairs Executive

Position Details

Job Title: Regulatory Affairs Executive
Department: Regulatory Affairs
Industry: Nutraceutical / Healthcare
Reports To: Managing Director / Head – Regulatory Affairs
Location: Mallapur, Hyderabad
Employment Type: Full time

Job Purpose

To manage and support regulatory activities for nutraaceutical products in international markets, ensuring timely preparation, submission, maintenance, and compliance of regulatory dossiers in accordance with applicable country-specific regulations and global regulatory requirements.

Key Responsibilities

1. Regulatory Submissions
- Prepare, compile, review, and coordinate regulatory dossiers for nutraceutical products for international markets.
- Support preparation and submission of CTD/eCTD and country-specific dossiers as applicable.
- Coordinate preparation of registration documents, application forms, administrative documents, product information, declarations, and supporting documents.
- Ensure submissions are complete, accurate, compliant,



and submitted within agreed timelines.
- Track submission status and maintain regulatory submission records.

2. Regulatory Compliance
- Monitor and interpret applicable regulatory guidelines and requirements for assigned countries/markets.
- Ensure regulatory activities comply with applicable requirements of agencies such as US FDA, EMA, MHRA, TGA, Health Canada, GCC, ASEAN, African regulatory authorities, and other relevant health authorities, as applicable.
- Support regulatory impact assessments for changes to products, manufacturing processes, specifications, analytical methods, packaging materials, sites, and suppliers.
- Maintain awareness of changes in regulatory guidelines and communicate their impact to relevant departments.

3. Post-Approval Regulatory Activities
- Coordinate variations, renewals, amendments, extensions, and other post-approval regulatory submissions.
- Maintain product registrations and ensure time

📌 Regulatory Affairs Executive (Hyderabad)
🏢 Lactonova Nutripharm
📍 Hyderabad