
Senior Regulatory Affairs Professional
9 hours ago
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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