Associate Director, Global Regulatory Affairs

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 working with a global, science-led biopharmaceutical company to find an Associate Director of Regulatory Oncology. This is a chance to join a newly built US regulatory team at an early stage, with a global remit and real influence over how oncology medicines reach patients worldwide as several launches approach.

The Role

You will be accountable for developing, adapting, and executing regulatory strategies for oncology programs across development and marketed products, for a specific region or worldwide. You’ll be the primary link between Global Regulatory Affairs and R&D, franchise, and commercial teams, with responsibility across international markets. The initial focus is Oncology, with the potential to expand into other therapeutic areas over time.

What You’ll Do

• Provide regulatory input into target product profiles and integrated asset strategic plans, including target indications, positioning, and key differentiators
• Define the optimal path to the target product profile, with the right sequencing of indications, dosage forms, and geographies
• Shape the optimal label, balancing commercial expectations, regulatory requirements, and development outcomes
• Define and execute strategy for health authority consultations, including scientific advice and planned agency meetings
• Advocate for proposed strategies and secure buy-in from senior leaders and health authorities
• Identify risks early and propose mitigation options to project teams and senior management
• Support upcoming product launches and major regulatory submissions, carrying strategy beyond marketing authorization to include pricing and reimbursement considerations
• Ensure regional regulatory needs are built into global plans in partnership with local and intercontinental teams
• Oversee outsourced regulatory activities to keep them on time and on budget
• Monitor scientific evolution, competitor activity, and the external environment, and communicate emerging trends to stakeholders
• Build effective relationships with global regulators and take part in external influencing activities with health authorities and trade associations
• Lead or contribute to operational excellence initiatives within Global Regulatory Affairs

What You Bring

• Advanced degree (or equivalent) in a scientific discipline such as pharmacy, medicine, chemistry, or biological sciences
• Approximately 7+ years in pharmaceutical regulatory affairs, with Oncology experience essential
• 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 record of finding creative regulatory solutions while balancing agency expectations and compliance across regions
• A strong track record of working in a matrixed environment and bringing groups together around innovative regulatory solutions
• Excellent written and verbal communication skills, with the ability to influence decision makers inside and outside the organization

Nice to Have

• Experience across additional therapeutic areas
• A track record of building strong relationships with the FDA
• Knowledge of the EU and Asia Pacific regulatory environments, particularly China and Japan