Global Oncology Regulatory Director

Biopharma Careers; Billerica (MA); On-site; USD 172,000 - 231,000; Full time

Benefits offered by this job

Health insurance

PTO

Retirement contributions

Perquisites

Job summary

EMD Serono seeks a Director of Global Regulatory Affairs to define and execute the global regulatory strategy for oncology programs, leading cross-functional teams and coordinating with major health authorities.

You will mentor staff, oversee submissions across regions, and ensure compliance with global regulations from our Billerica, MA site. English proficiency and strategic leadership are essential for success.

Qualifications

• Advanced degree (e.g., PhD, PharmD, MD, or equivalent).
• At least 6 years of regulatory experience with at least 3 years in Oncology.
• Demonstrated track record in strategy development and HA/EMA/FDA interaction.

Responsibilities

• Develop and execute global regulatory strategy for oncology programs.
• Lead regulatory submissions and lifecycle management across regions.
• Manage interactions with health authorities (FDA, EMA) to facilitate approvals.
• Provide strategic regulatory input to portfolio teams; data-driven decisions.

Skills

Regulatory strategy

HA/EMA/FDA interactions

Cross-functional leadership

English proficiency

Project management

Stakeholder management

Education

Advanced degree (PhD/PharmD/MD)

Tools

eCTD submissions

Job description

EMD Serono seeks a Director of Global Regulatory Affairs to define and execute the global regulatory strategy for oncology programs, leading cross-functional teams and coordinating with major health authorities.

You will mentor staff, oversee submissions across regions, and ensure compliance with global regulations from our Billerica, MA site. English proficiency and strategic leadership are essential for success.