Senior Regulatory Affairs Specialist

5 days ago

Mumbai, Maharashtra, India beBeeRegulatoryAffairs Full time US$ 1,20,000 - US$ 1,80,000
We are seeking a highly skilled Regulatory Affairs Consultant to join our team. As a key member of our regulatory group, you will be responsible for leading cross-functional teams in the assessment and management of regulatory submissions and their impact on product registrations.

Key Responsibilities:
  • Lead assessments and presentations to governance bodies
  • Prepare and submit EU PIs, MRP DCPs, and CAPs for urgency level updates
  • Provide strategic inputs for labeling tasks
  • Serve as worldwide contact person for labeling topics
  • Assess deviations of local labels from Company Core Documents (CCDs)
  • Understand regulatory implications of product strategy with regards to product label assessment and practical management of associated impacts
  • Support and coordinate audit and inspection-related activities
  • In case of updates, propose labeling updates, prepare necessary documentation, and brief Client colleagues from Global Labelling about labeling strategies and content
Qualifications we seek in you:

Minimum Qualifications:
  • At least Bachelor's degree required in pharmaceutical science, engineering, or related field; advanced degree preferred

Genpact is an equal opportunity employer committed to diversity and inclusion.

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