Manager - Regulatory Affairs

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.