Senior Regulatory Affairs Specialist

We are seeking a detail-oriented and proactive Regulatory Affairs Associate to join our Global Regulatory team. In this role, you will be responsible for development and execution of CMC regulatory strategies, marketing applications and Life Cycle Management for biosimilar products.

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 GRA Biosimilars function

KNOWLEDGE AND SKILLS

• 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

• Anticipate and prevent potential issues

• Ability to communicate regulatory strategies and requirements to ensure expectations are understood