Formulation Regulatory Affairs Specialist – Biocon
About Company:
Biocon is an innovation-led, fully integrated biopharmaceutical company developing affordable biosimilars, generic formulations, and complex APIs.
Job Details:
| Position | Formulation Regulatory Affairs Specialist |
|---|---|
| Organization | Biocon |
| Location | Bengaluru |
| Salary | ₹13.6 Lakhs per annum |
| Qualifications | B.Pharm, M.Pharm |
| Experience | 8 to 12 years in Regulatory Affairs |
Position Name: Formulation Regulatory Affairs Specialist
Organization: Biocon
Location: Bengaluru
Salary: ₹13.6 Lakhs per annum
Qualifications:
- B.Pharm, M.Pharm
Experience Required:
- 8 to 12 years in Regulatory Affairs
Key Responsibilities:
- Prepare, review, and timely submit ANDA in the US market
- Manage deficiency and lifecycle for products filed in the US
- Review technical documentation for dossier submission
- Provide regulatory inputs to cross-functional teams during product development and manufacturing
- Publish regulatory dossiers into eCTD format as per country requirements
- Maintain regulatory databases concurrently with regulatory updates
- Understand requirements related to US regulatory submissions
How to Apply:
If you are interested in this opportunity, please share your updated resume.
