
Manager - Regulatory Affairs
2 days ago
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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