Regulatory Affairs Officer

Company Overview

Renown Pharmaceuticals Pvt. Ltd. is a reputable soft gelatin contract manufacturer with a state-of-the-art facility in Vadodara, India. The company upholds the highest quality standards and aims to be a top producer of soft gelatin capsules in India. Renown Pharma is known for its adherence to regulatory standards like MHRA, TGA, and WHO-GMP, providing contract manufacturing services for nutraceutical and therapeutic formulations.

Job Overview

Regulatory Affairs Officer at Renown Pharmaceuticals Pvt. Ltd. in Vadodara. Full-Time position for candidates with 1-3 years of experience. Salary range: Competitive. 200+ employees at the company. Renown Pharma is a leading soft gelatin contract manufacturer with a global presence in 25+ countries and 150+ customers.

Qualifications and Skills

Knowledge of regulatory requirements

Excellent communication skills

Ability to interpret complex regulations

Experience with regulatory submissions

Regulatory compliance knowledge

Experience in ROW market

Dossier Preparation expertise

M. Pharma qualification

Roles and Responsibilities

Ensure compliance with regulatory requirements for product registrations

Prepare and submit regulatory documents and filings

Interpret and apply complex regulations for product approval

Coordinate with regulatory authorities for inspections and approvals

Conduct regulatory assessments and contribute to product development