Compliance Manager

2 days ago


Mumbai, Maharashtra, India beBeeLabeling Full time ₹ 15,00,000 - ₹ 17,00,000
Regulatory Compliance Specialist

We are seeking a highly skilled Regulatory Compliance Specialist to join our organization. This role involves preparing and reviewing product labels, leaflets, and packaging for compliance with global regulations.

Key Responsibilities:
  • Preparing and reviewing product labels, leaflets, and packaging for compliance with global regulations
  • Collaborating with cross-functional teams including regulatory, medical, and commercial
  • Maintaining labelling documentation and change control records
  • Safety signal assessments, creating and maintaining CCDS
  • Experience in providing labelling support across study phases
  • Supporting/leading Labelling Working committee groups/Labelling review committee
  • Performing detailed gap analysis of Product Information against regulatory reference products, to determine highest level of safety information
Requirements:
  • Authoring updates using all relevant HA guidelines and latest templates
  • Preparing variation packages
  • Undertaking literature reviews
  • Post-approval activities

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