We are hiring for Regulatory Affairs -API for Bangalore Location with 2-10 Years of Experience.
JD:
1. 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.
2. 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.
3. Compilation of response to queries received from Regulatory Agencies & customers globally and submission of response within the stipulated timeline. 4. Assessment of change proposals from regulatory perspective.
Email ID: upendra.kamma@biocon.com
Qualification: Post Graduation.
