Ensure product registrations with drug/medical device regulatory agencies in India, Nepal and Bhutan and manage all pharmacovigilance (PV) related activities. Liaisoning with Health Authorities (HA): To be based in New Delhi where Indian HA (CDSCO, HQ) is located and liaise with the CDSCO officials for all physical copy submissions and follow up for the progress of the project. Ensure all regulatory requirements are complied including liaison with local FDA, port drug controllers, National Pharmaceutical Pricing Authority/ Price control organisations, Central or State drug testing laboratories and Central FDA (CDSCO). To Manage any other regulatory and PV compliance activities including coordinating with various internal and external stakeholders to achieve the set objectives.
Candidate Profile :
Bachelor’s degree in Pharmacy, medicine or any life science subjects Desired: Masters in Pharmacy (Licensed Pharmacist) or life science subjects, medicine or doctoral degree Proficient in English
Minimum: Overall more than 4 years in regulatory affairs role / 1-2 years’ experience as Regulatory Affairs Manager Desired: 3+years’ experience as Regulatory Affairs Manager, specifically working with Indian regulatory authorities and in Medical Devices.
Experience: 4 years
Qualification: B.Pharm, M.Pharm
Industry Type: Pharma/ Healthcare/ Clinical research
Functional Area: R&D
Job ID: 201303BR
Last Date: 29th December, 2016
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