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Biocon Limited Recruiting For Sr. Executive/ Assistant Manager – Regulatory Affairs API

Biocon Limited is looking to hire Sr. Executive/ Assistant Manager – Regulatory Affairs API .Interested and eligible candidates can send their resume.Biocon Limited is a globally recognized, innovation-led organization that is enabling access to high quality, advanced therapies for diseases that are chronic, where medical needs are largely unmet and treatment costs are high…….The eligibility criteria as follows.

Vacancy details :

Company Name : Biocon Limited
Department :Regulatory Affairs
Designation : Sr. Executive/ Assistant Manager – Regulatory Affairs API
No. of Vacancies : :NA
Location :Bengaluru
Qualification : B.Sc.M.sc
Experience :05-09+
Salary : Not Disclosed by Recruiter

 

Job description:-.

  • 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.

How to Apply :  Click here for full details and Apply

Author: Niranjan Reddy

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