Drug Regulatory Affairs Professional

4 days ago

Mumbai Mumbai City Navi Mumbai, India beBeeRegulatory Full time ₹ 5,00,000 - ₹ 20,00,000
Job Overview

We are seeking a highly skilled Regulatory Affairs Specialist to join our organization in India. The ideal candidate will be responsible for ensuring compliance with regulatory requirements for pharmaceutical products, managing submissions, and facilitating communication with regulatory bodies.

  • Strong understanding of FDA, ICH, CMC, and labeling requirements

Key Responsibilities:

  • Prepare and submit regulatory documents to government authorities in compliance with regulations.
  • Review and assess product labeling and promotional materials for compliance with applicable laws.
  • Maintain knowledge of changes in regulations and guidelines that may affect product approvals and compliance.
  • Coordinate with cross-functional teams including R&D, Quality Assurance, and Marketing to ensure regulatory requirements are met.
  • Assist in the preparation of responses to regulatory agency inquiries and inspections.
Required Skills and Qualifications
  • Bachelor's degree in Pharmacy, Life Sciences, or a related field.
  • 2-4 years of experience in drug regulatory affairs, preferably in the pharmaceutical industry.
  • Strong knowledge of Indian regulatory framework and guidelines related to drugs and pharmaceuticals.
  • Excellent written and verbal communication skills to effectively convey complex regulatory concepts.
  • Ability to work collaboratively in a team environment and manage multiple projects simultaneously.
About This Role

This role requires a detail-oriented individual who can ensure compliance with regulatory requirements and maintain accurate records.

The ideal candidate will have strong organizational skills, excellent communication skills, and the ability to work well under pressure.

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