Develop and execute on regulatory strategies to enable timely product approvals and lifecycle management in key markets including but not limited to US and Canada.
Provide strategic regulatory advice to optimize product development (new and marketed products) and speed to market e.g. via Fast Track and Breakthrough Designations.
Assess changes to marketed products and lead post-approval submissions in key markets, including but not limited to US and Canada.
Coordinate and prepare responses to submissions related questions.
Review and contribute to submissions for products in development and marketed products, including INDs/CTAs, Clinical Study Protocols, CBEs, PAS and other documents of regulatory relevance.
Lead, co-ordinate and review the preparation of briefing documents for regulatory authority meetings, including team rehearsals, slides and minutes.
Lead interactions with FDA, Health Canada, and other regulatory bodies; manage negotiations and responses to agency queries.
Represent GE HealthCare PDx in regulatory meetings and industry forums.
Collaborate with R&D, Manufacturing, Quality, Clinical, and the Commercial team to integrate regulatory requirements into development plans and commercialization strategies.
Represent Regulatory Affairs on cross-functional global project teams and internal/external meetings.
Work closely with cross-functional teams to timely execute project related activities and regulatory submissions.
Foster a culture of compliance, agility, and continuous improvement.
Ensure adherence to FDA, Health Canada, and ICH guidelines; maintain compliance and registration dossiers.
Drive initiatives to improve regulatory efficiency and proactively manage compliance risks.
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.
Bachelor’s degree in Life Sciences, Pharmacy, or related field; advanced degree preferred.
5+ years of regulatory affairs experience in the pharmaceutical industry in major markets such as in US and Canada with a track record of success of submissions and approvals including new applications and post-approval changes.
Expertise in regulatory pathways from IND through approval, launch, and lifecycle management; strong understanding of CMC, Quality, non-clinical, and clinical components.
Experience leading meetings with regulatory agencies such as FDA and Health Canada.
Background in sterile injectables; radiopharmaceutical experience is a strong asset
Strategic thinker with strong analytical and problem-solving skills.
Strong communication and negotiation skills.
Proactive, solution-oriented mindset with risk management capabilities.
Ability to work effectively in multinational and multicultural environments.
Strong project management and organizational skills; ability to manage complex priorities.
GE HealthCare offers a great work environment, professional development, challenging careers, and competitive compensation. GE HealthCare is an Equal Opportunity Employer. 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.
GE HealthCare will only employ those who are legally authorized to work in the United States for this opening. Any offer of employment is conditioned upon the successful completion of a drug screen (as applicable).
While GE HealthCare does not currently require U.S. employees to be vaccinated against COVID-19, some GE HealthCare customers have vaccination mandates that may apply to certain GE HealthCare employees.
Relocation Assistance Provided: No
Skills Required
- Bachelor's degree in Life Sciences, Pharmacy, or related field
- Advanced degree (preferred)
- 5+ years regulatory affairs experience in the pharmaceutical industry in US and Canada with track record of submissions and approvals
- Expertise in regulatory pathways from IND through approval, launch, and lifecycle management; strong understanding of CMC, Quality, non-clinical, and clinical components
- Experience leading meetings and negotiations with regulatory agencies such as FDA and Health Canada
- Background in sterile injectables
- Radiopharmaceutical experience (strong asset)
- Strong communication and negotiation skills
- Strong project management and organizational skills
GE Healthcare Compensation & Benefits Highlights
The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about GE Healthcare and has not been reviewed or approved by GE Healthcare.
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Healthcare Strength — Healthcare coverage is portrayed as comprehensive, including medical, dental, and vision options with HSA-eligible choices and preventive care coverage. Mental health and well-being support programs are also emphasized as part of the overall package.
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Retirement Support — Retirement support is described as meaningful, with a 401(k) match and additional programs such as student-loan matching in some descriptions. Legacy pension and retiree medical obligations for certain closed groups also signal continued support for long-tenured populations.
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Strong & Reliable Incentives — Variable and role-linked earning opportunities appear attractive in some job families, including high on-target earnings potential in certain sales roles. Additional role-based perks like company cars and travel-related reimbursements further increase the perceived value of total rewards in those positions.
GE Healthcare Insights
What We Do
Every day millions of people feel the impact of our intelligent devices, advanced analytics and artificial intelligence. As a leading global medical technology and digital solutions innovator, GE Healthcare enables clinicians to make faster, more informed decisions through intelligent devices, data analytics, applications and services, supported by its Edison intelligence platform. With over 100 years of healthcare industry experience and around 50,000 employees globally, the company operates at the center of an ecosystem working toward precision health, digitizing healthcare, helping drive productivity and improve outcomes for patients, providers, health systems and researchers around the world. We embrace a culture of respect, transparency, integrity and diversity.
