Global Regulatory Affairs Portfolio Lead, Marketed Products, Radiopharma

Title: Global Regulatory Affairs Portfolio Lead, Marketed Products, Radiopharma

Location: Remote USA

Full time

Job Description:

The GRPL is responsible for the oversight and management of the registration and lifecycle maintenance of a portfolio of product Marketing Authorizations in Pharmaceutical Diagnostics - Radiopharmaceuticals. In this role they will provide regulatory leadership, technical expertise, strategic guidance and delivery of registrations and lifecycle management of the current portfolio of approved products within Pharmaceutical Diagnostics, as assigned. They will apply sound regulatory judgement and translate regulatory requirements into actionable strategies, assess the external regulatory environment and emerging trends, and support regulatory approvals that advance the assigned marketed product portfolio.

Responsibilities:

• Oversee all regulatory activities for the assigned portfolio, including variations, renewals, and regulatory commitments.

• Give appropriate regulatory input (including strategic impact) into commercial plans.

• Ensure compliance with global regulatory requirements and evolving health authority expectations.

• Provide strategic oversight to Regional Regulatory Heads and National RA on regulatory activities that will impact their territories.

• Ensure Regulatory leadership and others, as required, are informed about the status of significant regulatory submissions and notify of any issues that require input or have significant risks to current business.

• Ensure key actions within the Regulatory Information Management systems are performed within appropriate timeframes and to the accepted quality.

• Plan and participate in regulatory agency meetings to support regulatory strategy and product lifecycle activities.

• Lead and/or support forums for sharing of best practices and lessons learned related to regional regulatory activities, ensuring a globally coordinated approach and no duplication of effort across territories.

• Build internal and external networks with key stakeholders to influence regulatory outcomes.

• Interpret the external regulatory environment and regulatory precedence to ensure continual portfolio optimization.

• Attend key business meetings and ensure appropriate regulatory representation based on the discussion topics.

• Ensuring regional regulatory needs are gathered, understood and implemented into Regulatory strategies.

• Contribute into the regulatory budget process in alignment with business strategy.

Desired Characteristics

• Ability to comprehend and communicate key regulatory requirements and expectations.

• Excellent project management skills and managing multiple activities/changes with the ability to change priorities quickly.

• Ability to prioritize daily/monthly/yearly tasks as per business need.

• Ability to educate and influence internal and external stakeholders.

• Openness to adopting digital technologies and AI-driven solutions to enhance efficiency and continuous improvement.

• Experience in regulatory affairs within the radiopharmaceutical sector is desirable.

Required Qualifications:

• Bachelor's degree in Life Sciences, Pharmacy, Chemistry, or related field.

• Significant experience in Regulatory Affairs with strong focus on post-approval lifecycle management.

• Proven experience working in cross-functional global teams.

• Experience in interfacing with global regulatory agencies.

• Strong communication skills.

• Strong project management and prioritization skills with the ability to effectively manage multiple tasks and priorities.

For U.S. based positions only, the pay range for this position is $132,000.00-$198,000.00 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