Regulatory Affairs Specialist
4 days ago
As a Regulatory Affairs Specialist with Biocon, you will be responsible for preparing and reviewing ANDA/ANDS applications for the US market. This role requires a deep understanding of life cycle management for products filed in the US market.
About the Role
The ideal candidate will have hands-on experience with preparation, review, and submission of ANDA/ANDS in the US market. Additionally, they should possess comprehensive knowledge on regulatory guidelines and requirements.
Key Responsibilities:
- Preparing and reviewing ANDA/ANDS applications for the US market
- Maintaining regulatory databases and publishing regulatory dossiers into eCTD format
- Reviewing technical documents required for dossier submission
- Providing necessary regulatory inputs to cross-functional teams during product development and manufacturing stages
Requirements:
- Hands-on ANDA/ANDS filing expertise
- A stable background in pharmaceutical regulations
- Experience with US submissions
- Well-versed with regulatory guidelines
What We Offer:
We offer an estimated salary range of $90,000 - $140,000 per year, depending on experience.
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