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