Regulatory Affairs Specialist

4 weeks ago


Vadodara, Gujarat, India Renown Pharmaceuticals Pvt. Ltd. Full time

At Renown Pharmaceuticals Pvt. Ltd., we are seeking a highly skilled Regulatory Affairs Officer to join our team in Vadodara.

About the Role

As a Regulatory Affairs Officer, you will be responsible for ensuring compliance with regulatory requirements for product registrations, preparing and submitting regulatory documents and filings, interpreting and applying complex regulations for product approval, coordinating with regulatory authorities for inspections and approvals, and conducting regulatory assessments and contributing to product development.

Key Responsibilities

  • Regulatory Compliance: Ensure compliance with regulatory requirements for product registrations.
  • Regulatory Submissions: Prepare and submit regulatory documents and filings.
  • Regulatory Interpretation: Interpret and apply complex regulations for product approval.
  • Regulatory Coordination: Coordinate with regulatory authorities for inspections and approvals.
  • Regulatory Assessments: Conduct regulatory assessments and contribute to product development.

Qualifications and Skills

  • Regulatory Knowledge: Knowledge of regulatory requirements.
  • Communication Skills: Excellent communication skills.
  • Regulatory Compliance: Regulatory compliance knowledge.
  • Regulatory Experience: Experience with regulatory submissions, regulatory compliance, and regulatory affairs.

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

This is a 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.



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