Regulatory Affairs Executive

Company : Cadila Pharmaceutical Ltd.

About Us : Cadila Pharmaceuticals Ltd, is one of the Largest Privately- held Pharmaceuticals companies in India. Over the past seven decades, We have been developing and manufacturing affordable medicines for the patients around the world.

About the Role

A Regulatory Affairs Executive for the Africa market plays a critical role in ensuring products comply with regional regulations and maintaining market access across diverse countries. This position requires a blend of technical expertise, communication, project management, and analytical skills to navigate the complex regulatory landscape in Africa

Responsibilities

• Preparation and submission of registration and re-registration dossiers as per country requirements i.e. African countries, FWA countries and Nepal
• Submission of various original documents for notarization, chamberization and legalization which forms an important part of dossier.
• Arrangement for Indent of Samples, Packing Material specimen, Impurities, Reference Standards as per MOH requirement.
• Establish Coordination with other departments like QA / QC, R&D, Marketing and Purchase for ensuring the filings and query response within time frame.
• Post approval activities : Submission of variations to the terms of marketing authorizations for finished products as per respective variation guideline.
• Preparation of COPP's (Certificate of Pharmaceutical Product) and FSC to be submitted to Local FDA approvals.
• Preparation of Tender documents.
• Enhance self-awareness about changing regulatory requirements.

Qualifications

M. Pharma / B.Pharma

Required Skills

Having experience in Pharmaceutical Industries in African Market