Job Description
• 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
Candidate Profile
• 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.
• 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.
Additional Information
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
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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