Timely execution of RA activities as per the IMETA strategy and the OPU business priorities.
Compilation of the dossier as per local regulations and requirements.
Maintain MA and support product shipments.
Engagement with local graphic offices (if applicable) and maintenance of RA databases.
Tracking and archiving the acknowledgments/dossier in hard and soft copies on common drive
Communicate and discuss new/updated information within regulatory environment, competitive regulatory intelligence and/or new requirements in the country with the OPU and IMETA stakeholders.
Support to compile the required regulatory expertise to support future BI portfolio.
Qualification & Experience
Bachelor Degree in Pharmacy or similar medical education
Pharma experience with regulatory focus in a multi-national for at least 6-8 years.
Experience of direct interactions with Regulatory Authorities.
Prior people management experience is an asset.
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