Division: Intas Animal Health Exports

Area of Operation: Emerging Markets Intas Animal Health

Grade: Executive

Internal key customers: Regulatory Affairs, Supply Chain, Artwork team, LLM, Technical, Plant & Marketing.

External customers: Regulatory authority, Distributor, Regulatory agents, CMOs,

Requirements : B. Pharm/M. Pharm & 3-5 years of work experience in similar role.

Core Competencies

- Develop and implement regulatory strategies for product registration in emerging markets specifically SEA, Middle east, Africa & Latin America.
- Identify country-specific regulatory pathways, requirements, and timelines
- Artworks, Change request, FGEX creation & BOM Initiation
- Positive Communication, and presentation Skills
- Digital /Excel / Power point / word proficiency

Key Job Responsibilities

Regulatory Affairs- Emerging Markets

- Compile, review, and submit dossiers for product registrations. eCTD dossier experience preferable.




- The role ensures that pharmaceutical products comply with country-specific regulatory requirements throughout their lifecycle, from dossier submission to post-approval maintenance
- Manage submissions such as: Response to queries, Variation/Post approval changes, Retention & Renewal.
- Maintain product licenses, artwork and regulatory databases
- Provide visibility of upcoming approvals for effective New Product launch activities.
- Should be well verse with Artwork software for Initiation of artwork and follow-up to ensure that Artworks approval for AH products.
- Initiate, follow-up and approval of all CRFs
- Master Data Management Creation FGEX, Sale test & BOM
- Cross Functional Collaboration for specific issues resolution.

📌 Executive_ Regulatory Affairs_ International Animal Health (Ahmedabad)
🏢 Intas
📍 Ahmedabad