Regulatory Affairs Professional

2 days ago


Thāne, Maharashtra, India beBeeRegulatory Full time ₹ 15,00,000 - ₹ 25,00,000
Regulatory Affairs Professional

We are seeking a highly skilled Regulatory Affairs professional to take on the responsibility of ensuring compliance with regulatory requirements.

  • Preparation and review of Standard Operating Procedures (SOPs)
  • Management of Quality Management System (QMS) activities
  • Preparation and review of Drug Master File (DMF) documentation
  • Knowledge of international and domestic audit practices
  • Annual Product Quality Review (APQR) preparation
  • Drugs Master File preparation
  • Liaison with regulatory agencies
  • Review and implementation of quality agreements

This is an exciting opportunity for someone who has a strong understanding of regulatory requirements and excellent communication skills.

Key Qualifications:
  • Experience working in the pharmaceutical industry
  • Strong understanding of regulatory requirements
  • Excellent communication and organizational skills
Responsibilities:
  • Develop and implement regulatory strategies to ensure compliance
  • Manage relationships with regulatory agencies
  • Oversee the preparation and review of regulatory documents


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