US Based Global Regulatory Lead

Job Description SummaryYou will provide regulatory strategy and direction to the business regarding healthcare industry regulatory requirements for product launch, premarket submissions/registrations and postmarket compliance, working closely with healthcare regulatory bodies globally. Has in-depth knowledge of best practices and how own area integrates with others; has working knowledge of competition and the factors that differentiate them in the market.

Our Pharmaceutical Diagnostics (PDx) business is the number one global supplier of contrast media and molecular imaging agents used to enhance medical imaging exams. Used throughout all major disease area diagnostic and treatment pathways, PDx products support three patients every second around the world.

Job Description

• You will provide regulatory strategy and direction to the business regarding healthcare industry regulatory requirements for product launch, premarket submissions/registrations and post market compliance, working closely with healthcare regulatory bodies globally

• Typically a 1st line manager of professionals or a 2nd line manager of a professional department. Developing specialized depth and/or breadth of expertise in own job discipline or field. Serves as best practice/quality resource. Has awareness of latest functional developments in own area. Contributes towards strategy and policy development, and ensures delivery within area of responsibility.

• Skilled influencer, able to communicate complex messages to others. Acts as a resource for colleagues with less experience. May lead small projects with moderate risks and resource requirements. Explains difficult or sensitive information; works to build consensus. Developing persuasion skills required to influence others on topics within field.

• Impacts approaches, projects and programs in the functional area or affected business organization and ways of working. Impacts quality, efficiency and effectiveness of own team. These jobs have significant input into their priorities. Jobs at this level tend to be covered by professional practices and policies but these are shaped by the role. Working within broad guidelines and policies, roles at this level have moderate autonomy, requiring high levels of evaluative judgment.

• Uses judgment to make decisions or solve moderately complex tasks or problems that impact the function. Takes new perspective on existing solutions. Uses technical experience and expertise for data analysis to support recommendations. Uses multiple internal and limited external sources outside of own function to arrive at decisions.

Required Qualifications

• Bachelor’s degree with 10+ years’ experience of global regulatory affairs from the pharmaceutical and/or healthcare industry with a track record in key strategic roles.

• Experience of regulatory submissions and approvals in key regions such as EU, US and APAC, including new MAAs/NDAs.

• Significant experience of regulatory project management and regulatory authority interactions.

• Experience working with business leadership to define high level strategies.

• Experience working effectively across multinational/cultural environments.

• Maintaining a keen interest in scientific advances that impact healthcare product development and regulation.

Desired Qualifications:

• Skills and knowledge in specialized areas key to specific business need, such as oncology/ immuno-oncology products or biologics. 

• Master's degree or PHD

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.

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.

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Legal authorization to work in the U.S. is required. We will not sponsor individuals for employment visas, now or in the future, for this job opening. 

For U.S. based positions only, the pay range for this position is $144,000.00-$216,000.00 Annual. It is not typical for an individual to be hired at or near the top of the pay range and compensation decisions are dependent on the facts and circumstances of each case. The specific compensation offered to a candidate may be influenced by a variety of factors including skills, qualifications, experience and location. In addition, this position may also be eligible to earn performance based incentive compensation, which may include cash bonus(es) and/or long term incentives (LTI). GE HealthCare offers a competitive benefits package, including not but limited to medical, dental, vision, paid time off, a 401(k) plan with employee and company contribution opportunities, life, disability, and accident insurance, and tuition reimbursement.

Additional Information

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

Application Deadline: July 03, 2024 Apply