Senior Director, Global Regulatory Strategy

Discover International; Washington (District of Columbia); Hybrid; USD 200,000 - 260,000; Full time

Job summary

Discover International in Washington, DC area seeks a Senior Director of Regulatory Strategy to lead global regulatory efforts for development and commercial programs. You will guide health authority engagement and align cross-regional teams on regulatory input across development stages and markets.

With 12+ years in regulatory affairs and a track record of leading in matrixed organizations, you will mentor teams, influence senior management, and shape strategies to drive product development and

Qualifications

• Bachelor’s degree in biology, chemistry, or a related field.
• At least 12 years in pharmaceutical or biotech regulatory affairs, including 5+ years in a supervisory or management role.
• Expert command of global, regional, and local regulations and guidance for human medicines across development, registration, and maintenance.
• A track record of building and evaluating proposals to regulatory authorities and leading productive health authority interactions
• Experience advising development teams on refining regulatory pathways as outcomes evolve
• Proven success leading within a matrixed, cross-functional organization
• Strong written, verbal, and presentation skills, with the ability to influence at every level
• A strategic, business-minded approach and a commitment to coaching, mentoring, and inclusive leadership

Responsibilities

• Create and drive global regulatory strategies for multiple or complex programs, captured in Global Regulatory Strategy Documents
• Direct regulatory submission documents and health authority communications across regions
• Represent Global Regulatory Affairs on core development and project teams, working with regional leaders to deliver consistent regulatory input into clinical programs and commercial strategy
• Counsel senior management on the progress of regulatory strategies and tactics, and resolve complex issues with sophisticated regulatory solutions
• Manage project plans, timelines, and resources to keep priorities on track
• Bring matrixed, cross-functional teams into alignment on regulatory requirements, timelines, and deliverables
• Shape the regulatory landscape through participation in conferences, agency and industry meetings, committees, and trade associations
• Monitor regulations, policy, and competitive intelligence, and adapt strategy before changes take effect
• Drive continuous improvement of department processes
• Lead, coach, and develop regulatory team members through skill-building and performance feedback

Skills

Regulatory strategy

Regulatory affairs

Leadership

Stakeholder influence

Cross-functional collaboration

Communication skills

Strategic thinking

Coaching/mentoring

Education

Bachelor’s degree in biology, chemistry, or a related field (or an equivalent mix of education and experience)

Job description

Discover International in Washington, DC area seeks a Senior Director of Regulatory Strategy to lead global regulatory efforts for development and commercial programs. You will guide health authority engagement and align cross-regional teams on regulatory input across development stages and markets.

With 12+ years in regulatory affairs and a track record of leading in matrixed organizations, you will mentor teams, influence senior management, and shape strategies to drive product development and