Biocon Recruiting For Assistant Manager/ Deputy Manager- Regulatory Affairs API

Biocon Hiring B.Pharm,M.Pharm.B.Sc.M.sc .Biocon is Asia’s premier biopharmaceutical company that is driven by the vision to make a difference to global healthcare through improved access to high quality, life-saving biotherapeutics by making them affordable for patients across the world..Interested and eligible candidates apply online with link provide at bottom and check eligibility before apply and Eligibility details as follows .

Vacancy details :

  • Company Name: Biocon
  • Location :Bengaluru
  • Post Name:Assistant Manager/ Deputy Manager- Regulatory Affairs API
  • Qualification: B.Pharm,M.Pharm.B.Sc.M.sc
  • Experience :05-09 Years
  • No of Vacancies : 01
  • Salary:Not Disclosed

Job Description/skills Required: 

  • Compilation and submission of DMFs globally for new small molecule APIs in eCTD format and in-line with ICH and region specific (EU, US, Canada, Japan, Australia, Brazil, China, South Korea etc.) regulatory guidelines. Self-review of the compiled DMF to ensure that it is error-free.
  • Compilation and submission of amendment to existing DMFs globally in eCTD format and in-line with ICH and region specific (EU, US, Canada, Brazil etc.) regulatory guidelines. Self-review of the compiled DMF to ensure that it is error-free.
  • Compilation of response to queries received from Regulatory Agencies & customers globally and submission of response within the stipulated timeline.
  • Assessment of change proposals from regulatory perspective.

Selection Process: Shortlisted candidates may called for selection process including personal interview and Group discussion ,Exam

How to Apply : Click here for full details and apply

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