
Strategic Regulatory Compliance Specialist
1 week ago
We are seeking a detail-oriented and proactive Regulatory Affairs Associate to join our team.
Key Responsibilities- Plan and manage 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.
- Provide regulatory direction on global regulatory requirements to support product development.
- Ensure all filings are maintained per regulatory requirements and consistent with biosimilar strategy throughout product development and life cycle.
- Provide review, input, and regulatory advice into study concept CMC documents, protocols and reports used to support product development and registration.
- Ensure and lead regulatory compliance for biosimilar products.
- Partner with regulatory team members to research and communicate relevant regulatory information regarding biosimilar products.
- Escalate regulatory issues, progress, and metrics to the Biosimilars function.
- Comprehensive understanding of Regulatory activities.
- Experienced in analytical method development, method validation, method transfers and characterization of biologic products. Regulatory experience with product filings.
- Ability to understand and communicate scientific CMC information.
- Able to anticipate and prevent potential issues.
- Ability to communicate regulatory strategies and requirements to ensure expectations are understood.
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