Senior Regulatory Affairs Professional

9 hours ago


Thāne, Maharashtra, India beBeeregulatory Full time ₹ 1,04,000 - ₹ 1,30,878

Job Summary:

We are seeking a highly skilled Regulatory Affairs Manager to join our team. As a key member of our regulatory department, you will be responsible for managing the work deliverables by ensuring balanced and timely coordination with Business Development, regulatory agents, and cross-functional stakeholders.

Key Responsibilities:

  • Preparing and submitting regulatory dossiers in Mexico and LATAM countries
  • Managing work deliverables to ensure balanced and timely coordination with BD, regulatory agents, and cross-functional stakeholders
  • Liaising with cross-functional teams for registration documents and reviewing them
  • Liaising with regulatory agents in Mexico and LATAM countries to address their requirements for regulatory filings
  • Addressing queries or deficiencies from regulatory agencies, partners, or regulatory agents to ensure product registration in the shortest time
  • Handling post-approval requirements and filings
  • Ensuring dossiers are submitted and registered as per schedule

Qualifications & Requirements:

  • Regulatory experience in Mexico and LATAM markets at managerial position
  • Must have an M.Pharm/M.Sc degree
  • Good communication and planning skills

About the Role:

  • Must be able to work in different shifts


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