Beschreibung

In this leadership role, you will shape global regulatory strategies for vaccine development, guide cross-functional teams, and ensure compliance with regulatory requirements while interacting with authorities to expedite approvals.

Anforderungen

• •BA or BS in a relevant scientific or technical discipline
• •15+ years industry experience demonstrating technical and regulatory expertise
• •Graduate education and/or professional certifications in regulatory and/or quality
• •10+ years of extensive and relevant regulatory experience
• •Proven record of achievement in developing regulatory submissions
• •Thorough understanding of clinical development and statistics
• •Direct experience engaging multiple health authorities
• •Demonstrated ability to lead and manage cross-functional teams
• •Direct experience developing clinical regulatory strategies
• •Demonstrated record identifying clinical and regulatory risks
• •Experience translating and integrating regulatory intelligence
• •Articulate oral and written communication skills
• •Active listening skills
• •Strategic and tactical critical thinking
• •Constructive operational productivity
• •Adaptability
• •Flexible and optimistic demeanor

Aufgaben

• •Develop and execute global clinical regulatory strategies
• •Author and review regulatory CMC documentation for submissions
• •Provide regulatory guidance for cross-functional development teams
• •Ensure compliance with current regulatory requirements
• •Serve as the primary contact with regulatory authorities
• •Contribute to product label claims and justifications
• •Lead negotiations with global regulatory authorities
• •Support safety and pharmacovigilance notifications
• •Provide guidance on regulatory intelligence and changes
• •Manage cross-functional teams for regulatory compliance
• •Optionally oversee people development and management

Benefits