Hello,
There is an opening for "Regulatory Affairs" with RUSAN PHARMA LTD (R&D center) at Gandhidham Location.
B Pharma / M Pharma with 3-9 years of Experience in preparing and submission of dossiers as per country requirement (Semi Regulated/ROW Countries)
Job Location : Gandhidham - Kutch Location (Candidates should be ready to relocate Gandhidham Location)
Job Role:
Working with Operations for Publishing of the Dossier (Independently Module 1- 5) as per country requirements (eCTD/CTD/National Requirements).
Chair of Labelling Sub team Meetings (LST) which includes Subject Matter Experts from Medical Affairs, Pharmacovigilance, Clinical Development and Nonclinical Development.
Maintain awareness of changes to/new regulations affecting Pharmacovigilance activities.
Knowledge of Preparation & compilation and reviewing the documents which is coming from manufacturing site for the preparation of dossiers for various countries along with legal documentations.
Tender file Preparation, as per the bid documents.
Regulatory activities include pre licensing activities, new registration of products, post licensing regulatory submissions, interaction with health authorities of respective countries.
Best Regards
Priti Singhvi
RUSAN PHARMA LTD - Gandhidham Location (R&D center)
Corporate HR
Direct Line : 022-42383063
pr**********i@ru********a.com
,Company ProfileRusan Pharma LtdRusan is a research driven pharmaceutical company having its Manufacturing Units in India and Worldwide Marketing of Pharmaceutical Formulation, Active Pharmaceutical Ingredients and Intermediates. The company has its own Research & Development centre at Kandivli (we...