Director of Regulatory Affairs

Discover International; Boston (MA); On-site; USD 180,000 - 260,000; Full time

Job summary

Discover International is seeking a Director, Global Regulatory Affairs — Oncology to lead regulatory strategy and execution for oncology programs. You will partner with global clinical development teams to navigate milestones, submissions, and lifecycle activities.

The ideal candidate has 6+ years in regulatory affairs, strong oncology experience, and proven FDA/EMA interactions, with the ability to influence cross-functional teams in a complex matrix environment.

Qualifications

• 6+ years of regulatory affairs experience in pharma/biotech.
• 3+ years of oncology regulatory experience.
• Experience interacting with major health authorities (FDA/EMA).
• Experience leading global regulatory strategies.
• Ability to lead cross-functional teams in a matrixed organization.
• Excellent written and verbal English communication.

Responsibilities

• Develop and execute global regulatory strategies for oncology programs.
• Lead regulatory submission planning and execution across regions.
• Serve as regulatory representative in FDA/EMA interactions.
• Provide strategic regulatory guidance to clinical development and portfolio teams.
• Assess regulatory risks and translate requirements into actionable plans.
• Lead cross-functional teams to align development plans and submission deliverables.
• Prepare for health authority meetings and regulatory milestones.
• Contribute to lifecycle planning including new indications.
• Mentor regulatory colleagues and promote proactive risk management.

Skills

Regulatory strategy

Cross-functional leadership

FDA/EMA interactions

English communication

Regulatory strategy execution

Education

Advanced degree (PharmD/MD/PhD)

Tools

eCTD submissions

Job description

Director, Global Regulatory Affairs — Oncology

A growing biopharmaceutical organization is seeking a Director, Global Regulatory Affairs to lead regulatory strategy and execution for oncology development programs. This individual will serve as a strategic regulatory partner across global clinical development teams, helping guide programs through key development milestones, regulatory interactions, submissions, and lifecycle activities.

The ideal candidate brings strong oncology regulatory experience, a track record of successful interactions with major health authorities, and the ability to influence cross-functional teams in a complex, matrixed environment.

Key Responsibilities

• Develop and execute global regulatory strategies for oncology programs across clinical development and commercialization.
• Lead regulatory submission planning and execution across multiple regions and support ongoing lifecycle management activities.
• Serve as a key regulatory representative in interactions with global health authorities, including the FDA and EMA.
• Provide strategic regulatory guidance to clinical development, program, portfolio, and cross-functional teams.
• Assess regulatory risks and opportunities and translate evolving regulatory requirements into actionable program strategies.
• Lead cross-functional teams to align regulatory requirements, development plans, timelines, and submission deliverables.
• Partner with internal stakeholders to prepare for health authority meetings, submissions, and regulatory milestones.
• Ensure regulatory strategies and deliverables remain aligned with applicable global and regional requirements.
• Contribute to lifecycle planning, including opportunities for label expansion and additional indications.
• Mentor and support regulatory colleagues while promoting strong regulatory practices and proactive risk management.

Qualifications

Required:

• Advanced degree such as PharmD, PhD, MD, or equivalent scientific/technical degree.
• 6+ years of regulatory affairs experience within the pharmaceutical or biotechnology industry.
• 3+ years of current, direct oncology regulatory experience.
• Demonstrated experience developing and executing regulatory strategies for oncology programs.
• Experience interacting directly with major health authorities, particularly the FDA and/or EMA.
• Experience with global regulatory submissions and eCTD/dossier requirements.
• Ability to lead cross-functional teams within a matrixed organization.
• Strong strategic thinking, communication, influencing, and stakeholder management skills.
• Excellent written and verbal English communication skills.

Preferred:

• Experience supporting oncology programs from early development through later-stage development and/or commercialization.
• Experience with lifecycle management, label expansions, and/or additional indications.
• Strong understanding of evolving global oncology regulatory requirements.
• Experience preparing for and participating in health authority meetings.
• Demonstrated ability to identify regulatory risks and develop practical mitigation strategies.
• Experience mentoring or developing regulatory affairs professionals.
• Ability to balance strategic planning with hands‑on execution.