[Hiring] Senior Portfolio Owner Regulatory Affairs @rexx systems

Role Description

The job of the Senior Portfolio Owner Regulatory Affairs is to provide end-to-end ownership of all regulatory and product-related activities, ensuring a strong product strategy that supports compliance, product availability, patient safety, and effective risk management. The role acts as the central point of accountability and escalation while coordinating operations, driving regulatory strategy, and providing disciplinary and functional leadership to the product team. By fostering cross-functional alignment, prioritizing operational activities, and involving relevant experts when needed, the role ensures effective collaboration and high-quality outcomes across departments.

• Strategic Product & Regulatory Ownership: End-to-end responsibility for all regulatory and product-related activities within the portfolio.
• Regulatory Strategy & Compliance Management: Develop and drive the global regulatory strategy while overseeing all submission activities, agency interactions, and regulatory processes across the entire product lifecycle.
• Team Leadership & Operational Management: Provide disciplinary and functional leadership to the product team, including task prioritization, resource allocation, budget responsibility, and continuous development of team capabilities.
• Cross-Functional Coordination & Stakeholder Management: Ensure strong cross-functional alignment with internal departments, acting as the central escalation point for regulatory and product-related topics.
• Risk Management & Strategic Decision-Making: Assess complex regulatory and business risks and develop sustainable solutions under uncertain conditions.
• External Partner & Outsourcing Oversight: Lead and oversee external service providers and outsourcing activities, ensuring quality, compliance, and performance.
• Innovation, Governance & Continuous Improvement: Continuously evaluate regulatory developments, market trends, and available methodologies to improve processes and strengthen governance structures.

Qualifications

• Master’s degree in a relevant scientific or pharmaceutical discipline.
• More than 10 years of professional experience in Regulatory Affairs within the pharmaceutical industry.

Requirements

• More than 10 years of proven leadership experience managing large, cross-functional Regulatory Affairs organizations at senior management level.
• Strong ability to manage and resolve conflicts at high organizational and political levels.
• Excellent indirect leadership, communication, and influencing skills across multiple hierarchical levels.

Benefits

• A growing company with a diverse, open working environment and employees from around 40 countries.
• Individually customizable working models, including the option to work from another EU country for up to two months per year. 30 days of holiday.
• Flexible benefits budget for increased company pension provision, fitness and health offers, or subsidies for travel and meal costs.
• Access to the corporate benefits platform with discounts at hundreds of partner companies.
• Internal and external training courses tailored to personal goals, as well as company and team events to strengthen cohesion.