Graviti Pharmaceuticals - Regulatory Affairs Professional

Title : Regulatory Affairs Professional

Location : Hyderabad, Telangana

Experience : 5-8 years

Employment Type : Full-time, On-site

About Graviti Pharmaceuticals :

Graviti Pharmaceuticals, headquartered in Hyderabad, India, is a research-driven pharmaceutical organization specializing in the development and manufacturing of high-quality, complex generic formulations. With expertise in modified-release formulations, bio and stability-sensitive molecules, and innovative drug delivery systems, the company is committed to providing affordable and superior healthcare solutions.

Graviti Pharmaceuticals consistently adheres to stringent international regulatory standards, ensuring excellence, reliability, and transparency across all operations. These core values drive the organizations long-standing partnerships and its reputation for quality within global markets.

Role Overview :

The Regulatory Affairs Professional will play a critical role in managing regulatory submissions, ensuring compliance with regional and international guidelines, and supporting product development for key global markets, specifically Europe and the United States.

This is an on-site position requiring close collaboration with cross-functional teams, including R&D, QA, QC, Formulation Development, and Manufacturing. The ideal candidate will be skilled in dossier preparation, lifecycle management, regulatory strategy, and communication with regulatory authorities.

Key Strategy & Compliance :

• Develop, implement, and maintain regulatory strategies for assigned products targeting EU and US markets.
• Ensure adherence to regional regulatory requirements (EMA, MHRA, FDA) for complex generic formulations.
• Monitor, interpret, and communicate regulatory changes, guidelines, and updates to internal stakeholders.

Dossier Preparation & Submissions :

Renewals, Amendments and responses to queries

Document Management & Coordination :

Authority Interactions :

Qualifications & Skills :

Educational Background :

Technical Expertise :

Professional Experience :

Core Skills :

Why Join Graviti Pharmaceuticals :

(ref : iimjobs.com)