Renown Pharmaceuticals is known for its state-of-the-art manufacturing facility in Vadodara, offering contract manufacturing services for both nutraceutical and therapeutic formulations. With a workforce of over 200 employees, the company serves more than 150 customers across 25 countries. Its focus on producing soft gelatin capsules has made it a trusted name in the global pharmaceutical industry.
Job Overview
The Regulatory Affairs Officer will be responsible for ensuring that the company’s products meet all necessary regulatory standards. The position involves dossier preparation, regulatory submissions, and compliance for the ROW (Rest of World) Market.
Key Responsibilities
- Regulatory Compliance: Ensure compliance with all regulatory requirements for product registrations in both domestic and international markets.
- Dossier Preparation: Prepare and submit comprehensive regulatory documents, including dossiers, as per regulatory guidelines.
- Interpreting Regulations: Interpret and apply complex regulatory guidelines for product approval and maintain regulatory compliance.
- Coordination with Authorities: Work closely with regulatory authorities during product inspections and approval processes.
- Regulatory Assessments: Conduct regulatory assessments to support product development and maintain up-to-date knowledge of regulatory trends and changes.
Qualifications and Skills
- Education: B.Pharm, M.Pharm, Msc
- Experience: 0-3 years of experience in regulatory affairs.
- Technical Skills: Strong knowledge of ROW market regulations and experience in regulatory submissions.
- Communication Skills: Excellent communication skills for interacting with regulatory bodies and internal teams.
- Attention to Detail: Ability to interpret complex regulations and ensure thorough compliance with legal standards.
How to Apply
Candidates who meet the qualifications and are interested in joining a dynamic team at Renown Pharmaceuticals can apply through the company’s website or via quick apply options. This is an excellent opportunity for professionals in regulatory affairs to grow their careers in a global organization with a strong reputation for quality.
