Director, Global Regulatory Affairs
$171,600–$230,900 year
On-siteBillerica, Massachusetts, United States
Job Summary
Develop and execute global regulatory strategy for oncology programs, leading regulatory submissions and lifecycle management across multiple regions. Manage interactions with major health authorities such as the FDA and EMA to facilitate approvals and label extensions. Lead a cross-functional, matrix-driven team to align on regulatory requirements, timelines, and deliverables while ensuring compliance with global regulations and quality standards. Mentor junior colleagues and monitor the evolving regulatory landscape to adapt strategies accordingly. Provide strategic regulatory input to portfolio teams with a data-driven approach. This onsite role in Billerica, MA requires at least three days of presence per week.
Required Qualifications
- Advanced degree (e.g., PhD, PharmD, MD, or equivalent)
- At least 6 years of relevant regulatory experience
- At least 3 years in Oncology
- Demonstrated track record as an effective strategy developer
- HA/EMA/FDA interaction expert
- Proven ability to lead in a matrixed, cross-functional environment
- Strong written and spoken English communication skills
- Excellent project management skills
- Influencing skills
- Ability to drive programs across complex organizations
- Must be able to work onsite at least 3 days per week at the Billerica, MA facility
Desired Qualifications
- Proficiency in other languages
- Strategic thinker with a hands-on, execution-focused mindset
- Strong stakeholder management capabilities
- Negotiation capabilities
- Ability to manage competing priorities
- Clear gaze on risk management
- Compliance focus
- Experience with global regulatory submissions (eCTD/dossier delivery)
- Lifecycle planning experience
- Patient-centric mindset
- Commitment to scientific rigor
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