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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.
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We are driven by the belief that the pharmaceutical industry has a humanitarian responsibility to provide essential drugs to patients who are in need and to do so with the power of innovation. In line with this belief, Biocon has developed and commercialized a differentiated portfolio of novel biologics, biosimilars, and complex small molecule APIs in India and several key global markets, as well as, generic formulations in the U.S. and Europe. We are a leading global player for biosimilars and APIs for statins, immunosuppressants, and other specialty molecules, with customers in over 120 countries.
We have built an employee-friendly environment for our gender-diverse workforce that is comparable to the best in the world. This has been validated once again by our position among the Top 20 Best Employers in the Biotech Industry as ranked by the prestigious Science magazine. We have been recognized for being a socially responsible organization with loyal employees who are providing global leadership in innovation.
Position: Assistant Manager/Sr Executive – Regulatory Affairs
Location: Bengaluru, Karnataka, India
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 an 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 a regulatory perspective.
Desired Candidate Profile:
- At least 4 to 8 years of work experience in Regulatory Affairs for APIs
- Adequate knowledge in ICH, and various Regulatory Agencies guidelines
- Should have hands-on experience in eCTD software
- Very good writing skill in English
Qualification: B.Pharma/M.Pharma
Experience: 3-7 Years of Relevant Experience
Salary: Negotiable
Contact Details:
Pulla Rao
careers@biocon.com, human.resources@biocon.com, pullaroa.yarramsetti@biocon.com
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