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
- Review all data and documents related to product registrations for various health authorities.
- Compile registration dossiers for submission to various health authorities like – US-FDA, Health Canada, Europe, Australia/New Zealand, Japan and Israel.
- Prepare responses to deficiency letters received from various agencies.
- Maintain life-cycle / post approval changes for drug product registration dossiers.
- Provide regulatory support to cross functional departments.
- Prepare and submit scientific advice to various health authorities.
- eCTD compilation, verification and submission through electronic gateway
- Review, preparation and submission of annual reports to US FDA
- Review, preparation and submission of post approval supplements to US FDA
- Reviewing of the plant change control and established the variation strategy for submission
- Review of query response prepared and compiled by regulatory associates
- Review of all the documents received from stake holder for dossier compilation, Query response and Life cycle management
- Allocation of projects to regulatory associate & manage the team for all the regulatory submission activities
