Sun Pharma Hiring Senior Manager – Biologics/ Biosimilar – Regulatory Affairs – Regulated Market

About the job

Responsible for providing development support, preparation, review and submission of good quality dossiers (including response to agency deficiencies) for biologics/biosimilars for global markets, thereby enabling faster approvals and timely launch; also ensures business continuity through timely life-cycle management. Also responsible for development and management of team.

1. New Submissions: Work with Product Development (For Drug products) & other CFT (within and outside R&D) to ensure that sufficient and timely regulatory information and controls are included during design and development of drug products as per country specific regulatory requirements
2. Provide feedback in terms of document requirements & regulatory filing strategy during development of new DF (Drug Formulation). Review and approve documents on behalf of regulatory.
3. Preparation/review and submission of good quality dossiers thereby enabling faster approvals and timely launch
4. Preparation and submission of meeting packages/scientific discussion with Agency related to product development
5. Anticipate expected deficiencies and prepare mitigation plans
6. Approval: Prepare and submit timely response to deficiencies enabling approval of products.
7. Lifecycle Management for approved drug products
8. Timely preparation and submission of annual reports/renewals/DSUR’s
9. Evaluation, preparation and submission of changes through variations, supplements etc that impact product supplies
10. Regulatory Compliance – Ensure timely implementation of regulatory decisions for change management and other activities in DF plants
11. Ensure reposition of comprehensive product information into central repository
12. Self and People Development
13. Awareness of regulatory guidelines, participating and delivering presentations
14. Provide on job training to Research Associates/Managers

Participate in department initiatives including productivity & benchmarking tools aimed at improving performance.

Global with major focus on United State of America, European Union, Australia/New Zealand and Canada.

Apply HERE