
Regulatory Affairs Professional
3 days ago
We are seeking a detail-oriented and proactive Regulatory Affairs Associate to join our team. In this role, you will be responsible for the development and execution of regulatory strategies for biosimilar products.
The successful candidate will be accountable for planning and managing the development of high-quality regulatory documents, including briefing documents, CTAs, IND/IMPD, MAA/BLA, and responses to questions for products in compliance with approved filing plans, timelines, and regulatory requirements.
You will provide regulatory direction on global regulatory requirements to support product development and ensure that all filings are maintained per regulatory requirements and consistent with biosimilar strategy throughout product development and life cycle.
Required Skills and Qualifications:
- Comprehensive understanding of Regulatory activities
- Experienced in analytical method development, method validation, method transfers, and characterization of biologic products
- Ability to understand and communicate scientific CMC information
- Anticipate and prevent potential issues
- Ability to communicate regulatory strategies and requirements to ensure expectations are understood
Benefits:
This is an excellent opportunity to work with a dedicated team and contribute to the success of our biosimilar products.
The ideal candidate will have a strong background in Regulatory Affairs and experience working with biosimilar products.
Others:
Please note that we are looking for a highly motivated and detail-oriented individual who can work effectively in a team environment.
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