Sun Pharma an international,specialty pharmaceutical company headquartered in India with a global manufacturing network across 25 countries. We manufacture and market a large basket of pharmaceutical formulations as branded generics & generics in India, US and across the world. Our leadership is approachable, encourages transparency & strong work ethics to ensure that people get the best opportunities to learn and grow. We encourage our employees to challenge themselves for highest level of performance through greater bandwidth of work responsibilities and growth opportunities. Apply to us if you wish to be part of Sun Pharma growth story.
Job Title: Fresher / Trainee- India Regulatory Affairs
Experience: – 1 Years
Location : Vadodara
Job Description:
- Various domestic applications: CT, BE, CDTL, manufacturing and marketing, query replies, NCE application etc.
- Project evaluation as per DCGI checklist for document requirement and accordingly request of documents to the concerned departments.
- Preparation of covering letter, form-44, rationale, summary of drug-drug interactions, summary of pharmacological and toxicological data, brief chemical and pharmaceutical data for FDC applications, adequate evidence of concomitant administration for FDCs; Evaluation of documents; Final compilation of application.
- NDAC presentation : Preparation of executive summary for NDAC referral as well as 11 sets of NDAC dossier. Compilation of documents required for NDAC presentation e.g., sequence of events, application supporting, etc.
- Literature search : Extensive literature search for domestic application [for new drug, new dosage form, FDC, new indication]; Search for post-marketing studies for DCGI approved molecules; search for dietary products.
- Preparation of Schedule Y applications: adding data related to phase I, phase II, phase III, post marketing, formulation data, API data etc.
- Preparation of e-CTD application for subsequent new drugs.
Qualifications:
- UG -B.Pharma – Pharmacy
- PG – M.Pharma – Pharmacy
