Senior Director, Regulatory Affairs, Radiopharma

GE HEALTHCARE•Turin, PE

1d•$198,000 - $297,000•Onsite

About The Position

The Senior Director of Regulatory Affairs, Radiopharma serves as a senior global leader within the Pharmaceutical Diagnostics (PDx) Regulatory Affairs organization, reporting into the Global Head of Regulatory Affairs. This role provides end to end regulatory leadership across drug development, registration, lifecycle management, compliance, and CMC for key markets including the United States, while supporting global regulatory strategy, governance, and operational excellence. The Senior Director leads a multi regional team of global regulatory professionals and partners closely with regulatory regional teams and the cross functional leaders to advance the PDx product portfolio efficiently and compliantly.

Requirements

Bachelor’s degree in Life Sciences, Pharmacy, Chemistry, or related field; advanced degree strongly preferred.
12+ years of global regulatory affairs experience, including leadership roles with increasing responsibility.
Demonstrated success supporting or leading regulatory strategy and submissions in US, and other highly regulated agencies such as in Japan, China and in EU, across development, approval, and lifecycle phases.
Proven experience navigating US FDA requirements, regulations and pathways including but not limited to experience with Fast Track, Orphan Designation, Priority and Rolling Review, etc.
Strong expertise in Clinical and CMC regulatory strategy, with hands‑on experience guiding Clinical and CMC teams through development, registration, and global change management.
Proven experience managing and developing regulatory teams across multiple regions.
Deep understanding of global regulatory frameworks from IND/CTA through marketing approval, post‑approval changes, compliance, and pharmacovigilance‑related requirements.

Nice To Haves

Experience in sterile injectables, diagnostics, or radiopharmaceuticals.
Excellent strategic thinking, systems‑level problem‑solving, and decision‑making abilities.
Strong communication and negotiation skills, with ability to influence executives and regulators.
Excellent project management and organization skills; capable of leading multiple complex programs simultaneously.

Responsibilities

Develop, oversee and drive global regulatory strategies for assigned development programs and marketed products in US, and other priority markets supported by the regional regulatory teams, ensuring alignment with business objectives, regional requirements, and long‑term portfolio plans.
Provide strategic guidance from early development to registration and lifecycle, leveraging expertise across CMC, non‑clinical, clinical, and quality domains.
Monitor and interpret global regulatory trends, emerging guidances, and agency expectations to inform program design and risk mitigation strategies.
Serve as the senior regulatory lead in interactions with major health agencies including FDA, leading high‑stakes negotiations and ensuring high‑quality briefing packages and responses.
Represent the organization in global regulatory forums and external industry groups to influence evolving regulations and advocate for PDx‑relevant policy positions.
Partner with R&D, CMC, Manufacturing, Clinical, Medical, Quality, Commercial, and Supply Chain teams to integrate regulatory requirements into global product strategies, development plans, and launch readiness.
Communicate effectively opportunities and risks of proposed regulatory strategies.
Lead, mentor, and develop a global team of regulatory professionals across multiple regions, ensuring clear priorities, proper resource allocation, and high‑quality, timely execution.
Foster a culture of compliance, agility, scientific excellence, and proactive problem-solving, consistent with the expectations for senior leadership roles.
Ensure global compliance across development, submissions, registration maintenance, and post‑market activities.
Oversee preparation, accuracy, and maintenance of global regulatory dossiers, ensuring alignment across regions and adherence to corporate governance expectations.
Lead continuous‑improvement initiatives to enhance regulatory efficiency, operational excellence, and risk management.
Support due diligence activities for partnerships, acquisitions, and in‑licensing opportunities by assessing regulatory risks, pathways, and development strategies.
Contribute to regulatory budgeting, long‑range planning, and strategic portfolio prioritization.