Senior Director, EU Direct, A&Z, Canada

GE HealthCare

. Define, lead and drive the regional regulatory strategy across the entire product lifecycle, including development, registration and post‑authorization activities, in compliance with EMA, CMDh, national competent authorities and Health Canada requirements.

Posted 4/28/2026full-timeRemote • 🇺🇸 United StatesSeniorWebsite

About the role

Key responsibilities & impact

Define, lead and drive the regional regulatory strategy across the entire product lifecycle, including development, registration and post‑authorization activities, in compliance with EMA, CMDh, national competent authorities and Health Canada requirements.
Apply strategic regulatory thinking to anticipate regulatory risks and opportunities, enabling informed decision‑making for products in development as well as legacy products seeking new indications or markets.
Provide early, proactive regulatory input to development programs in support of the global Regulatory Affairs (RA) team, and influence clinical, CMC and data‑generation strategies to facilitate successful approvals.
Ensure close collaboration between the team and global RA for effective product lifecycle management, including variations, renewals, post‑authorization commitments and regulatory actions related to safety, while ensuring compliance.
Work closely with global RA to integrate local regulatory requirements and strategy into the product’s global regulatory strategy and requirements.
Serve as the senior regulatory interface with the EMA and EU national authorities, leading scientific advice requests, regulatory meetings and complex negotiations.
Lead, develop and coach the Regulatory Affairs team, ensuring clear accountability, well‑defined roles and skills development.
Contribute to overall regulatory governance, standardization and continuous improvement initiatives within PDx.
Support structured knowledge transfer, handover and risk‑management activities to ensure regulatory continuity.
Drive initiatives to improve regulatory efficiency and proactively manage non‑compliance risks.
Participate in due diligence activities related to product development, acquisitions and inbound licensing opportunities; assess regulatory risks and requirements.
Contribute to the Regulatory Affairs function’s budget planning.

Requirements

What you’ll need

Degree in life sciences, pharmacy or a related field; advanced degree preferred.
Minimum of 7 years’ experience in regulatory affairs within the pharmaceutical industry, with proven leadership experience in the region.
Expertise across regulatory pathways from development through approval, launch and lifecycle management; strong understanding of CMC, Quality, non‑clinical and clinical components.
Proven experience conducting meetings with regulatory authorities.
Experience with sterile injectable products; experience in radiopharmaceuticals is a major advantage.

Benefits

Comp & perks

Competitive salary
Flexible working hours
Professional development budget
Home office setup allowance
Global team events

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

regulatory strategyregulatory complianceclinical strategiesCMCdata generation strategiesregulatory governancerisk managementbudget planningregulatory pathwayslifecycle management

Soft Skills

leadershipcoachingcollaborationstrategic thinkingaccountabilitycommunicationinfluencingproblem-solvingnegotiationcontinuous improvement

Certifications

degree in life sciencesdegree in pharmacyadvanced degree in related field