Head Domestic Regulatory Affairs
Job Description
Designation: HEAD - Domestic Regulatory AffairsJob 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.:
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
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Job Detail
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Job IdJD3444084
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IndustryNot mentioned
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Total Positions1
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Job Type:Full Time
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Salary:Not mentioned
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Employment StatusPermanent
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Job LocationNew Delhi, India
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EducationNot mentioned
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ExperienceYear