Vacancy for M.Pharm, M.Sc, B.Pharm as Officer at Sanofi
Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions. With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe.
Post : Officer/Senior Officer
• Prepares regulatory submissions and ensure all the data supplied are of the highest quality possible in terms of both content and presentation whilst meeting agreed deadlines.
• Prepares responses to questions from regulatory agencies, affiliates, distributors and within Sanofi.
• Prepare, review and update summary documents, SOPs, etc. Performs other regulatory duties as required (e.g., document preparation for regulatory inspections).
• Maintains RA databases, core dossiers and summary documents.
• Working proactively with members of the Global Business Units and with other functions to ensure business needs are met compliantly within agreed timelines
• To maintain internal training matrix and co-ordinate trainings of regulatory staff as required
• 3 to 4 years prior experience in Regulatory Affairs related to biologicals/vaccines in India and or International countries.
• Technical writing skills.
• Preparation and review of different documents such as CTD, Clinical Trial Application, Marketing Authorization Application etc.
• Knowledge of biologicals regulatory pathways in India.
• Knowledge/experience in electronic submissions.
• Understanding of GMP, GDP and GLP.
• Computer software knowledge (e.g. MS Word, Excel, Power point etc.)
• Must have strong ability to grasp complex technical information and have problem solving skills, as well as the ability to handle multiple projects simultaneously.
Qualification : B. Pharm / M. Pharm. / M. Sc. / M. Tech
Location : Hyderabad
Areas of Specialization: Pharmacy, Microbiology, Biotechnology, Industrial-Microbiology, Virology, Bacteriology, Life Sciences.
Experience : 2-4 years
Industry Type : Pharma/ Healthcare/ Clinical research
End Date : 5th May, 2019
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