Global Regulatory Lead, Oncology

Millipore Corporation; Billerica (MA); Vor Ort; USD 172.000 - 231.000; Vollzeit

Benefits dieser Stelle

Health insurance

PTO

Retirement contributions

Other perquisites

Zusammenfassung

EMD Serono seeks a Director of Global Regulatory Affairs to define and execute the global regulatory strategy for oncology programs, ensuring timely approvals across geographies. Strong HA/EMA/FDA interaction expertise and cross-functional leadership are essential.

The role is onsite in Massachusetts, requires 6+ years in regulatory roles (3+ in oncology), and involves leading submissions, lifecycle management, and risk oversight with a patient-centric mindset.

Qualifikationen

• Advanced degree required (PhD/PharmD/MD or equivalent).
• Minimum 6 years regulatory experience with at least 3 years in Oncology.
• Proven track record leading HA/EMA/FDA interactions.
• Experience managing matrixed cross-functional programs.

Aufgaben

• Develop and execute global regulatory strategy for oncology programs within the Oncology TA.
• Lead regulatory submissions and lifecycle management across regions with the global regulatory team.
• Manage interactions with health authorities (FDA/EMA) to facilitate approvals and label extensions.
• Provide strategic regulatory input to portfolio teams and influence decisions with data-driven approaches.
• Lead a cross-functional, matrixed team to align regulatory requirements, timelines, and deliverables.
• Ensure compliance with global/regional regulations, quality standards, and governance.
• Mentor junior regulatory colleagues and promote regulatory excellence.
• Monitor evolving regulatory landscape to anticipate impact on programs.

Kenntnisse

Regulatory strategy

HA/EMA/FDA interactions

Cross-functional leadership

Project management

Stakeholder management

Ausbildung

Advanced degree (PhD/PharmD/MD)

Tools

eCTD submissions

Jobbeschreibung

EMD Serono seeks a Director of Global Regulatory Affairs to define and execute the global regulatory strategy for oncology programs, ensuring timely approvals across geographies. Strong HA/EMA/FDA interaction expertise and cross-functional leadership are essential.

The role is onsite in Massachusetts, requires 6+ years in regulatory roles (3+ in oncology), and involves leading submissions, lifecycle management, and risk oversight with a patient-centric mindset.