At Sun Pharma, we commit to helping you “Create your own sunshine”— by fostering an environment where you grow at every step, take charge of your journey and thrive in a supportive community.
Are You Ready to Create Your Own Sunshine? As you enter the Sun Pharma world, you’ll find yourself becoming ‘Better every day’ through continuous progress. Exhibit self-drive as you ‘Take charge’ and lead with confidence. Additionally, demonstrate a collaborative spirit, knowing that we ‘Thrive together’ and support each other’s journeys.”
Job Description
- Participates in activities related to new product registration/ new filing, re-registration, queries of regulatory agency and variation filing.
- Coordination with CRA, ADD, FDD, MSTG and PMO for regulatory requirements related to registration, re-registration, queries, and variation filing.
- Product life cycle management, change control evaluation and decision for final variation category followed by approval of change control in track wise system.
- Annual report: Details to be provided to QA for new registration filing details along with variation filing and approval details for respective countries.
- Preparation of CPID and Approval package, Co-ordination with corporate regulatory and plant team for impact analysis of proposed change against approved package and filing of variation whenever applicable.
- Review and approval of stability protocols, new product introduction forms, repackaging forms, stability discontinuation note and plan deviation (Whenever applicable) etc.
- Activities related to variation management - Tracking of variation filing, approvals and intimation to plant for implementation of changes.
- Arrangements of registration samples for regulatory submission purpose in ROW market.
- Circulation of regulatory approval and commitment details to plant team.
- Test License and Product permission procurement and management.
