Regulatory Affairs Specialist
6 days ago
About the Role:
We are seeking a highly skilled Regulatory Affairs Specialist to join our team at Biocon. As a key member of our regulatory affairs team, you will be responsible for ensuring that our products meet all necessary regulatory requirements in the US market.
Main Responsibilities:
- Product Submission and Lifecycle Management: Prepare, review, and timely submit ANDA applications for products in the US market. Manage deficiencies and ensure compliance with regulations throughout the product lifecycle.
- Technical Documentation Review: Review technical documentations required for dossier submission, including developmental and plant documentation.
- Cross-Functional Collaboration: Provide regulatory inputs to cross-functional teams during product development and manufacturing stages.
- eCTD Publishing: Publish regulatory dossiers in eCTD format as per country requirements.
- Regulatory Database Management: Maintain concurrent regulatory databases based on received updates.
- US Regulatory Requirements Understanding: Stay up-to-date on US regulatory submission requirements.
Qualifications:
M.Pharm/B.Pharm degree is required, with 6-10 years of experience in a similar role.
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