Director, Global Regulatory Affairs Lead (Oncology)
$171,750–$286,250 year
On-siteWaltham, Massachusetts, United States or Rockville, Maryland, United States
Job Summary
Develop appropriate regulatory strategies for assigned assets across multiple-year horizons, ensuring alignment with the Medicines Development Strategy and Integrated Evidence Strategic. Lead line management of Global Regulatory Strategy Therapy group staff, including mentoring, performance assessment, and workforce planning. Manage direct reports, drive resource demands, and assist in managing the team budget while recruiting new talent. Work closely with Portfolio Leads, global commercial teams, and local regulatory counterparts to secure labeling and lead regulatory interactions with Health Authorities. Advocate persuasively to senior leaders and ensure compliance with regulatory requirements throughout the product lifecycle.
Required Qualifications
- Bachelor's degree in biology, Life Sciences, Healthcare Sciences, Pharmaceutical Sciences, Regulatory Science, or a related scientific discipline
- 8+ years of experience in Regulatory Affairs within the pharmaceutical, biotechnology, or healthcare industry
- Experience leading Health Authority interactions, including preparation, execution, and follow-up activities related to regulatory milestone meetings
- Experience working on cross-functional development teams, including Clinical, Safety, Commercial, Statistics, CMC, and other R&D functions
- Experience assessing and applying regulatory precedent, regulatory intelligence, and evolving regulatory requirements to development or lifecycle management programs
- Experience supporting regulatory activities in major global markets, including the United States, European Union, or other international regulatory jurisdictions
- Experience ensuring compliance with applicable regulatory requirements, industry standards, and company policies throughout the product lifecycle
- Experience in resource management and forecasting
- Experience in all phases of the drug development process in regulatory affairs, including projects where there is little or no precedence
- Knowledge of relevant therapeutic areas or proven track record of being able to develop product
- Knowledge of clinical trial and licensing requirements in priority markets and sound knowledge globally
- Ideally, proven experience of leading regulatory activities outside local region
- Experience as a Global Regulatory Lead or equivalent leadership role
Desired Qualifications
- Advanced degree (PhD, MD, PharmD, or relevant master's degree) in biology, Life Sciences, Healthcare Sciences
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