This is General Manager / Sr. General Manager - Regulatory Affairs position in one of the leading pharmaceutical companies of India, where the selected person will be responsible for -
Position will responsible for regulatory requirements of regulated / Semi regulated and ROW market.
Review & Submission of DMF to various regulatory agencies.
Preparation & Review of registrations documents for various countries.
Regular update and communication with internal departments like QA, R&D for product development as per regulatory guidlines.
Co-ordination for New drug approval from DCGI
Provide training to junior team members
Other related activities.
Position is to be based at Ahmedabad