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|
|Designation||: Sr. Executive/ Assistant Manager – Regulatory Affairs API|
|No. of Vacancies :||:NA|
|Salary||: Not Disclosed by Recruiter|
- 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.
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