Global Regulatory Strategy Director

Discover International; Boston (MA); Vor Ort; USD 180.000 - 240.000; Vollzeit

Zusammenfassung

Discover International is seeking an experienced Global Regulatory Affairs leader to own regulatory strategy across development and post-marketing programs. You will lead interactions with health authorities, align regional plans, and coach a matrixed team of regulatory professionals to drive timely submissions and informed business decisions.

The ideal candidate brings 12+ years in regulatory affairs, including 5+ years of management, and a deep knowledge of global and regional regulations

Qualifikationen

• Bachelor’s degree in biology, chemistry, or a related discipline (or equivalent combination of education and experience)
• 12+ years in pharmaceutical or biotech regulatory affairs, including 5+ years of supervisory or management experience
• Expert knowledge of global, regional, and local regulations and guidance for human medicines across development, registration, and maintenance
• A proven record of creating and assessing proposals to regulatory authorities and leading productive health authority interactions
• Experience guiding development teams on refinements to regulatory pathways as outcomes evolve
• Success leading in a matrixed, cross-functional organization
• Strong communication and influencing skills at all levels, in writing and in presentations
• A business-minded, strategic approach and a commitment to coaching, mentoring, and inclusive leadership

Aufgaben

• Build and drive global regulatory strategies for multiple or complex programs, documented in Global Regulatory Strategy Documents
• Lead regulatory submission documents and health authority communications across regions
• Represent Global Regulatory Affairs on core development and project teams, partnering with regional leaders to give unified input into clinical programs and commercial strategy
• Advise senior management on the status of regulatory strategies and tactics, and resolve complex issues with advanced regulatory solutions
• Lead project plans, timelines, and resourcing so priorities are met on time
• Align matrixed, cross-functional teams on regulatory requirements, timelines, and deliverables
• Influence the regulatory environment through conferences, agency and industry meetings, committees, and trade associations
• Track regulations, policy, and competitive intelligence, and adjust strategy ahead of changes
• Lead continuous improvement of department processes
• Lead, coach, and develop regulatory team members, including skill development and performance feedback

Jobbeschreibung

Discover International is seeking an experienced Global Regulatory Affairs leader to own regulatory strategy across development and post-marketing programs. You will lead interactions with health authorities, align regional plans, and coach a matrixed team of regulatory professionals to drive timely submissions and informed business decisions.

The ideal candidate brings 12+ years in regulatory affairs, including 5+ years of management, and a deep knowledge of global and regional regulations