Position Overview:
The role involves leading strategic and operational aspects of Regulatory Affairs and Quality Assurance for clinical studies and product approvals. Key responsibilities include:
- Strategic Leadership: Develop and guide regulatory strategies, risk assessments, and critical issue management.
- Team Management: Build and lead a high-performing regulatory team, including hiring and mentoring staff.
- Regulatory Interactions: Manage and represent the company in meetings with regulatory authorities and handle submissions (e.g., IND, CTA, BLA, MAA).
- Expertise: Address complex scientific and regulatory issues, ensuring compliance with US and international regulations.
- Compliance and Quality: Oversee quality management systems and ensure adherence to regulations, including GCP, GVP, and GLP standards.
Requirements:
- Education: BS/MS required; PhD or MD preferred.
- Experience: 15+ years in Regulatory Affairs and Quality Assurance, with 10+ years in leadership roles. Significant experience with biologics and BLA/MAA submissions is essential.
- Specialized Knowledge: Infectious Disease, Vaccines, Covid, Flu
- Skills: Proven track record in regulatory negotiations and filings, and ability to work collaboratively across functions.
