Manager - Regulatory Affairs

2 days ago


Thāne, Maharashtra, India Rubicon Research Limited Full time

Purpose:

The position is for working on product registrations in Mexico and LATAM including compiling dossiers, answering queries from regulatory agencies, liaising with the cross-functional teams to obtain needful documents for product registration and co-ordinate on the requirements from the regional partners and regulatory agents. Managing the work deliverables by ensuring balanced and timely co-ordination with BD, regulatory agents and cross-functional stakeholders.

Job Responsibilities:

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

Qualifications & Pre-Requisites:

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

Additional notes

  • Will need to work in different shifts.


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