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 : Senior Officer
Candidate Profile
• M. Pharm or MSc in Life Sciences such as Microbiology, Biochemistry etc.
• Requires 6-8 years’ experience in regulatory affairs specifically experience in vaccines/ biologicals in the leading biopharmaceutical and vaccine industries
• Experience working on Project teams preferred
• Ability to make planning and execution of Regulatory affairs related activities
• Ability to manage multiple priorities efficiently
• Experience in handling and preparation of Clinical trial application (CTA), marketing authorization application (MAA), related amendments or variations and all routine license maintenance activities
• Ensures preparation of the components of the submission within pre-defined schedules in accordance with relevant RA procedures, tools, and templates, and coordinates the final submissions to regulatory authorities and/or to third parties.
• Up-to-date on regulatory guidance and technical/scientific developments.
• Requires in depth knowledge and understanding of the Indian, WH, European and International regulations/guidelines
• Experience in handling of regulatory inspection of various regulatory authorities (CDSCO, WHO, EMEA)
• Good skills in communication and teamwork
• Candidate should have competencies such as Act for change, Commit to customer, Transversal cooperation.
Additional Information
Experience : 6-8 years
Qualification : M.Pharm, M.Sc
Location : Hyderabad
Industry Type : Pharma
End Date : 20th June, 2019
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