Executive

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.

Position / Job TitleExecutiveDepartment

Regulatory Affairs

Reporting To

Manager, Regulatory Affairs

LocationThaneYears of Experience

5-10 years

Dosage Form

Any dosage form

Job Responsibilities

/ Deliverables

• Preparing and submitting regulatory dossiers in Mexicoand LATAM countries.
• Liaising with the cross-functional teamsfor 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 agenciesor 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 theschedule.
  
  

Qualifications & Pre- Requisites

• Regulatory experience in Mexico andLATAM markets
• Should be an M.Pharm/M.Sc
• Good communication andplanning skills.
  
  

Additional notes

• Will need to workin different shifts.