01 ago
|
Ge Healthcare
|
Italia
01 ago
Ge Healthcare
Italia
Job Description Summary
The Director of Marketed Products, Radiopharma reports to the Senior Director, RA – Radiopharma and is responsible for leading a global team managing all post-approval lifecycle activities for radiopharmaceutical products across worldwide markets. This role ensures regulatory compliance, drives forward-looking lifecycle and portfolio optimization strategies, enables the efficient execution of variations, renewals, and maintenance activities while collaborating closely with RA-CMC and NPI teams to support product continuity and lifecycle strategy.
Job Description
Key Responsibilities:
Strategic Leadership & Influence
- Define and drive the global lifecycle regulatory strategy aligned with corporate, portfolio, and product objectives, ensuring supply continuity and business value.
- Act as a strategic partner to senior leadership, communicating risks, opportunities, and regulatory scenarios to influence decision-making.
- Represent the lifecycle regulatory function in governance forums and cross-functional leadership discussions.
Leadership & Team Management
- Lead, coach, and develop a high-performing global regulatory team.
- Set clear objectives and drive accountability for timely, high-quality delivery.
- Manage resources, capabilities, and workload planning to meet portfolio priorities.
- Foster a collaborative, inclusive, and performance-driven culture.
- Promote adoption of digital tools and AI, building team capability in these areas.
Global Lifecycle Management & Regulatory Strategy
- Oversee all post-approval regulatory activities, including variations, renewals, and regulatory commitments.
- Lead regulatory strategy for post-approval changes, including impact assessment, pathway optimization, and risk mitigation.
- Lead the development and execution of global regulatory strategies for geographic expansion into new markets and label expansions (e.g.: new indications, formulations, populations).
- Ensure compliance with global regul
📌 Director, Regulatory Affairs, Marketed Products (Italia)
🏢 Ge Healthcare
📍 Italia