Job Description Summary

Il s’agit d’un poste de Directeur(trice) Senior. Le/La Directeur(trice) Senior, Affaires Réglementaires – UE Direct et Canada assure un leadership réglementaire stratégique et opérationnel de haut niveau pour le portefeuille Pharmaceutical Diagnostics (PDx) de GE HealthCare dans la région.
Ce rôle est responsable de la définition et de la mise en œuvre des stratégies réglementaires régionales, en particulier pour les produits en développement visant une première autorisation de mise sur le marché, ainsi que pour les produits historiques et déjà commercialisés recherchant de nouvelles indications, la maintenance et l’extension de leur cycle de vie, ou l’expansion vers de nouveaux marchés au sein de la région.
Ce poste garantit la continuité réglementaire, la conformité aux exigences réglementaires et le soutien des objectifs de croissance de PDx.

This is a Sr. director’s role. The Sr. director, Regulatory Affairs – EU Direct and Canada provides senior strategic and operational regulatory leadership for GE HealthCare’s Pharmaceutical Diagnostics (PDx) portfolio across the region. The role is accountable for defining and executing regulatory strategies in the region, specifically for products in development seeking initial registration, as well as for legacy and marketed products pursuing new indications, lifecycle maintenance and extensions, or expansion into additional markets in the region. This position ensures regulatory continuity, compliance, and support of PDx growth objectives.

Job Description

Key Responsibilities:

Regulatory Strategy & Execution

• Define, lead and oversee the regulatory strategy in the region across the product lifecycle, including development, registration, and post‑approval activities, in alignment with EMA, CMDh, national competent authority requirements and Health Canada.

• Apply strategic regulatory thinking to anticipate regulatory risks and opportunities, enabling informed decision‑making for products in development and legacy products seeking new indications or new markets.

Cross-functional Leadership
 

• Provide early, proactive regulatory input to development programs supporting the RA Global team, influencing clinical, CMC, and evidence generation strategies to support successful approvals.

• Ensure the team closely work with the RA global team for effective lifecycle management, including variations, renewals, post‑approval commitments, and safety‑related regulatory actions, maintaining compliance.

• Partner closely with the RA global team to integrate local regulatory requirements and strategy into overall product global regulatory requirements and strategy.

Agency Engagement

• Serve as the senior regulatory interface with EMA, EU national authorities, leading scientific advice, regulatory meetings, and complex negotiations.

People Leadership and Governance

• Lead, develop, and mentor the Regulatory Affairs team, ensuring clear accountability, role clarity, and capability development.

• Contribute to global regulatory governance, standardization, and continuous improvement initiatives across PDx.

• Support structured knowledge transfer, handover, and risk mitigation activities to ensure regulatory continuity.

• Drive initiatives to improve regulatory efficiency and proactively manage compliance risks.

Business Support

• Participate in due diligence for product development, acquisitions, and in-licensing opportunities; assess regulatory risks and requirements.

• Support budget planning for the Regulatory Affairs function.

Qualifications:

• Bachelor’s degree in Life Sciences, Pharmacy, or related field; advanced degree preferred.

• 7+ years of regulatory affairs experience in the pharmaceutical industry, with proven leadership in the region.

• Expertise in regulatory pathways from development through approval, launch, and lifecycle management; strong understanding of CMC, Quality, non-clinical, and clinical components.

• Experience leading regulatory agencies meetings.

• Background in sterile injectables; radiopharmaceutical experience is a strong asset.

Desired Characteristics:

• Strategic thinker with strong analytical and problem-solving skills.

• Excellent oral and written communication; ability to influence and negotiate effectively.

• Proven leadership and team development capabilities.

• Strong project management and organizational skills; ability to manage complex priorities.

Inclusion and Diversity:

GE HealthCare is an Equal Opportunity Employer where inclusion matters. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law.

Behaviours:

We expect all employees to live and breathe our behaviors: to act with humility and build trust; lead with transparency; deliver with focus, and drive ownership – always with unyielding integrity.

Total Rewards:

Our total rewards are designed to unlock your ambition by giving you the boost and flexibility you need to turn your ideas into world-changing realities. Our salary and benefits are everything you’d expect from an organization with global strength and scale, and you’ll be surrounded by career opportunities in a culture that fosters care, collaboration, and support.

#LI-Hybrid

#LI-AV1

Additional Information