Global Regulatory Oncology Lead — Associate Director

Discover International; Boston (MA); On-site; USD 180,000 - 240,000; Full time

Job summary

Discover International is seeking an Associate Director of Regulatory Oncology to lead regulatory strategies for oncology programs across development and marketed products. The role sits in a newly built US regulatory team with a global remit, driving launches and global submissions that influence patient access.

You will oversee target product profile development, health authority interactions, and labeling strategies while coordinating with R&D, franchise and commercial teams across regions.

Qualifications

• Advanced degree in a scientific field such as pharmacy, medicine, chemistry, or biology.
• 7+ years in pharmaceutical regulatory affairs with Oncology experience.
• Global regulatory experience managing complex worldwide products or projects across key geographies.
• Experience supporting oncology product launches or major regulatory submissions.
• Strategic thinking with a track record of balancing agency expectations across regions.
• Strong ability to lead in a matrixed environment and drive cross-functional alignment.
• Excellent written and verbal communication skills to influence stakeholders.

Responsibilities

• Provide regulatory input into target product profiles and strategic plans for indications, positioning and differentiators.
• Define optimal path to target product profiles, including indications, dosage forms, and geographies.
• Shape label strategy balancing commercial, regulatory, and development outcomes.
• Define and execute health authority consultations and planned agency meetings.
• Advocate for proposed strategies and secure buy-in from senior leaders and regulators.
• Identify regulatory risks early and propose mitigation options to project teams and senior management.
• Support upcoming product launches and major regulatory submissions, including pricing and reimbursement considerations.
• Ensure regional regulatory needs are integrated into global plans with local and intercontinental teams.
• Oversee outsourced regulatory activities to keep them on time and on budget.
• Monitor regulatory evolution and competitor activity, communicating trends to stakeholders.
• Build relationships with global regulators and participate in external influencing activities.

Skills

Regulatory strategy

Oncology

Global regulatory affairs

Stakeholder management

Matrix leadership

Strategic thinking

Education

Advanced degree in a scientific discipline

Job description

Discover International is seeking an Associate Director of Regulatory Oncology to lead regulatory strategies for oncology programs across development and marketed products. The role sits in a newly built US regulatory team with a global remit, driving launches and global submissions that influence patient access.

You will oversee target product profile development, health authority interactions, and labeling strategies while coordinating with R&D, franchise and commercial teams across regions.