Regulatory Affairs Officer

3 weeks ago


vadodara, India Renown Pharmaceuticals Pvt. Ltd. Full time

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







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