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 Objective
- To evaluate regulatory strategy for products to be registered in India.
- To co-ordinate with Cross Functional Team for getting various documents required for filing the product in India.
- Responsible for reviewing CMC documents to be submitted in dossier as per regulatory guidelines.
- To review specification for bulk drug and formulations as per regulatory expectation.
- Responsible for reviewing clinical trial and bioequivalence study documents to be submitted in regulatory applications.
- To search literature through various websites as per the application strategy.
- To prepare rationale on safety and efficacy of new drug/FDC by referring published literature.
- To prepare executive summary for SEC referral for drugs not approved in India.
- To get all final CMC/CT/BE final documents from cross functional team and compilation of dossier for regulatory submission.
- To file ND/SND/FDC application on SUGAM portal for getting domestic manufacturing and marketing permission / clinical trial permission etc.
- To review draft specimen or label and carton.
- To prepare prescribing information by referring international prescribing information.
