Global Oncology Regulatory Director — Strategy & Approvals

Discover International; Boston (MA); In loco; USD 230.000 - 300.000; Tempo pieno

Descrizione del lavoro

Discover International seeks a Director of Global Regulatory Affairs for its oncology portfolio. You will own global regulatory strategy from development through approval and label expansion, serving as the regulatory voice in cross-functional teams and leading interactions with major health authorities to shape program success.

You will lead multi-region submissions, lifecycle management, and risk assessments, while coaching junior team members and proactively tracking regulatory changes to

Competenze

• PhD, PharmD, MD or equivalent advanced degree.
• 6+ years in regulatory affairs, including 3+ years in oncology.
• Proven record of developing regulatory strategy and leading FDA/EMA interactions.
• Experience leading in a matrixed, cross-functional organization.
• Strong project management, influencing, and negotiation skills.
• Excellent written and verbal English.

Mansioni

• Build global regulatory strategies for assigned oncology assets.
• Lead multi-region submissions and lifecycle management with the broader global regulatory group.
• Plan and lead health authority interactions (FDA, EMA, and others) to secure approvals and label extensions.
• Advise leadership on regulatory risks and opportunities using data to support recommendations.
• Align matrixed teams on regulatory requirements, timelines, and deliverables.
• Ensure programs comply with global/regional regulations and internal governance.
• Coach and develop junior regulatory team members.
• Track changes in regulatory environment and adjust strategy accordingly.

Conoscenze

Regulatory strategy

FDA/EMA interactions

Cross-functional leadership

Project management

Negotiation

English proficiency

Formazione

PhD

PharmD

MD

Advanced degree

Descrizione del lavoro

Discover International seeks a Director of Global Regulatory Affairs for its oncology portfolio. You will own global regulatory strategy from development through approval and label expansion, serving as the regulatory voice in cross-functional teams and leading interactions with major health authorities to shape program success.

You will lead multi-region submissions, lifecycle management, and risk assessments, while coaching junior team members and proactively tracking regulatory changes to