6 August, 2022
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.
- 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
- 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.
- Preparation/review and submission of good quality dossiers thereby enabling faster approvals and timely launch
- Preparation and submission of meeting packages/scientific discussion with Agency related to product development
- Anticipate expected deficiencies and prepare mitigation plans
- Approval: Prepare and submit timely response to deficiencies enabling approval of products.
- Lifecycle Management for approved drug products
- Timely preparation and submission of annual reports/renewals/DSUR’s
- Evaluation, preparation and submission of changes through variations, supplements etc that impact product supplies
- Regulatory Compliance – Ensure timely implementation of regulatory decisions for change management and other activities in DF plants
- Ensure reposition of comprehensive product information into central repository
- Self and People Development
- Awareness of regulatory guidelines, participating and delivering presentations
- 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.