Greetings from 3G HR Services!!

We are hiring "Regulatory Affairs CMC."

Qualification: Graduation

Experience: 4+ Years

Salary: Based on last CTC

Location: Hyderabad

Skills:

- CMC Regulatory Affairs
- CMC Authoring
- CTD / eCTD Dossier Preparation
- Module 2 & Module 3 Documentation
- New Drug Product Submissions
- New Product Registration & Approvals
- US FDA / EMA / Health Canada Regulations
- Regulatory Lifecycle Management (LCM)
- ICH Guidelines
- Pharmaceutical Drug Substance & Drug Product Documentation

Market-Specific Experience (Any ONE Mandatory)

- USA / Canada: Experience with US FDA / Health Canada regulatory submissions.
- EU: Experience with EMA / European pharmaceutical regulatory submissions.
- Rest of World (RoW): Experience with pharmaceutical regulatory submissions in international markets.

Key Responsibilities

- Prepare and author CMC regulatory documents for new pharmaceutical product submissions and approvals.
- Develop, review and compile CTD/eCTD regulatory dossiers.




- Handle CMC documentation, particularly Module 2 and Module 3.
- Prepare regulatory documents related to Drug Substance (API) and Drug Products.
- Support recent product registrations and regulatory approvals.
- Handle post-approval changes, variations and lifecycle management activities.
- Ensure compliance with ICH guidelines and applicable regulatory requirements.
- Coordinate with R&D;, Quality Assurance, Manufacturing and cross-functional teams.
- 80% experience in CMC authoring for new product submissions and new product approvals.
- 20% experience in Regulatory Lifecycle Management (LCM).

Candidates We Are NOT Looking For

- Medical Device Regulatory Affairs professionals.
- Candidates with only publishing or labelling experience.
- Candidates with only post-approval LCM experience.

Contact: (phone hidden)

[email protected]

📌 Regulatory Associate | 4+ Years | US | EU | ROW | Hyderabad
🏢 3G HR Services
📍 Hyderabad