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Senior Officer

6.00 to 8.00 Years   Hyderabad   03 Jul, 2019
Sanofi India
Job LocationHyderabad
EducationNot Mentioned
SalaryNot Disclosed
IndustryPharma / Biotech
Functional AreaOperations Management / Process Analysis
EmploymentTypeFull-time

Job Description

  • 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.
,

Keyskills :
emeamarketinginspectionmaintenancempowerembeddedplanningclinicalteamwtemplatesregulatcomponents

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