E-DRUG: Vacancy: Regulatory Affairs and GMP Expert/Consultant, India
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Dear E-drug members,
We have an urgent requirement for the following position:
Regulatory Affairs and GMP Expert/Consultant
Job Description:
· Responsible for the overall Regulatory Affairs deliverables in
the projects
· Conduct assessments and audits of manufacturers (GMP compliance)
· Analyze the regulatory landscape in India and internationally
· Contribute to special assigned activities and projects on
Regulatory Affairs
· Write reports on projects
· Advise business and provide guidance/direction on regulatory
compliance issues by maintaining knowledge of company performance,
developing analysis, making recommendations and remaining current with
related trends to provide the information necessary to establish future
direction
Qualifications & Experience:
University degree (M.Pharm), Degree/diploma in Regulatory affairs would be
given preference
· Experience of 5-10 years in the area of pharmaceutical
development and Regulatory Affairs
· Hands-on experience of compilation, evaluation and submission of
registration dossiers to local and international regulatory agencies
· Experience of responding to questions and preparing a submission
for IND (investigational new drug), CTA (clinical trial application), NDA
(new drug application), and MAA (marketing authorizations)
· Thorough understanding of the drug development process (both
pre-clinical and clinical)
· Knowledge and awareness of current industry issues and evolving
trends in the regulated environment; both domestically and internationally
· Exposure of conducting company Audits/Inspection would be an
added advantage
· An excellent level of scientific and business English, spoken and
written is essential in order to develop successfully your job. It is
highly recommended to have strong computer knowledge at user level
Additional Information:
Location: New Delhi
Industry Type: Pharma/ Public Health
Functional Area: Regulatory Affairs
Job Type: Full Time
Employment Type: Permanent
Please contact tanvi.thareja@empowerpragati.in for further details.
Kind Regards
Nayeera Sadaf
Empower School of Health
India
+91 88 2601 1477
nayeera sadaf <nayeera.sadaf@empower.net.in>