Position: Sr. Manager M.Pharm/B.Pharm/M.Sc. having 12+ years’ experience in Regulatory Affairs for EU and other international markets such as Australia, Health Canada, New Zealand, South Africa
1. Expertise in authoring, reviewing CMC documentation for pre and post-approval submissions with hands-on experience on using eCTD software for EU and extension to other international markets such as Australia, Canada, Current Zealand, South Africa
2. Accountable for developing and executing regulatory strategies across the product lifecycle and managing effective agency interactions
3. Responsible for providing support and regulatory guidance to team in the completion of projects supporting regulatory filings.
4. Responsible for Product life cycle management
5. Co-ordination with internal & external stakeholders for effective submissions
6. Keep knowledge up to date about regulatory guidelines
7. Assessment of change control documents and provide accurate assessment of the change category
8. Manage administration of regulatory documentation and ensure the traceability of regulatory history (filing, archiving, database etc)