Head Domestic Regulatory Affairs

  
Designation: HEAD - Domestic Regulatory Affairs

Job Location: New Delhi
Eligibility criteria:
 Education :-   Minimum B.Sc., M.Sc., Preferable - B. Pharm, M.Pharm
Experience       Minimum experience of 15 years in Indian regulatory affairs and some past  experience in liasoning could be helpful.
 
Job Description:
1.       Preparation and submission of list of budgeted dossier submission (annual basis) by DRA to management
2.       Competitive Preparation and submission of list of  planned DCGI approvals (annual basis) to management along with a projection of approvals
3.       Strategic planning for formulation development of DCGI batches in Plant to ensure timely submission in CDSCO
4.       Handling DRA team involved in dossier compilation, review and submission in SUGAM (CDSCO) and FSSAI
5.       Handling work related to planning and timely procurement of Innovator sample
6.       Handling work related to CROs i.e. planning, selection, completion of BE,CT, Toxicity studies
7.       Handling planning and presentation to SEC committee in CDSCO
8.       Handling liasoning team for CDSCO and FSSAI and DGFT to expedite approvals
9.       Handling DRA's Review (fortnightly basis)
10.   Presenting DRA's MIS presentation (Quarterly basis) to management
11.   Preparation and submission of DRA's Performance review plan (PRP) (Quarterly basis) to HR department