Require Senior Officer at Sanofi @ Click here for more details
Post : Senior Officer
• 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.
Experience : 6-8 years
Qualification : M.Pharm, M.Sc
Location : Hyderabad
Industry Type : Pharma
End Date : 20th June, 2019