Senior Manager - Regulatory Affairs & Pharmacovigilance
Preparation of required documentation for new drug application, submission of the application & addressing the queries from local health authority
Follow up with local health authority
Variation notifications/approvals and renewals of already approved drugs
Arranging technical information/certificates/licenses to attend hospitals tenders
Review & approval of product artworks & promotional material following country code of good practices
Preparation and updation of Regulatory & local Pharmacovigilance SOPs according to GPV procedures and policies.
Training of all the employees with regard to safety reporting
Processing and reporting to GPV and Health Authorities wherever necessary, all safety information received from market, post-authorisation studies and Health Authorities.
Act as Local Safety Officer.
Regulatory support to development projects in terms of obtaining manufacturing & import test licenses
Registration of new products, variations for agency business i.e SriLanka, Nepal & Bangladesh
Regulatory knowledge for registration of local products and networking with drug authority
Qualification/Experience - B. Pharm with 10 years of Experience.
Ferring India M&S