Job Description Summary

We are seeking a highly motivated and detail-oriented Regulatory Affairs – CMC professional with a strong background in radiopharmacy or radiopharmaceutical development. The successful candidate will support global regulatory strategy and execution for both marketed and development-stage radiopharmaceutical products involving PET and SPECT tracers. This is a cross-functional role requiring close collaboration with CMC, QA, manufacturing, and supply chain teams to ensure continued regulatory compliance and support for post-approval changes across global markets.
The position is hybrid or fully remote.

Job Description

Roles and Responsibilities

• To be the regulatory CMC strategy point of contact for project teams and to provide CMC related regulatory input for the assigned projects/products
• Build, or provide input to, submission strategy documents by defining variation type, data required to support submission, and submission documents required for the submission package. Review and approve published output.
• Guide the project team in the project planning phase so that the correct data (and level of detail) to suit the needs of all markets is collected and submitted.
• Prepare and maintain CMC sections of global regulatory submissions, including INDs, IMPDs, NDAs, MAAs, variations, and supplements
• Provide consistent expert advice to the organisation, determining feasible regulatory strategies and identify potential options, to assist in delivering optimal business value or mitigate compliance issues
• To direct, manage and review outsourced regulatory CMC related regulatory activities for the assigned projects/products. 
• Maintain registration tracking information and assist in the development of good document management practice standards.
• Interact with regulatory agencies during scientific advice, pre-approval inspections, and post-approval queries
• To support QA during audits and inspections as required.

Required Qualifications

• Advanced degree in pharmacy, radiopharmacy, pharmaceutical sciences, chemistry, or related discipline (Doctor of Pharmacy (PharmD) or MSc in Radiopharmacy preferred)
• Minimum 3 years of experience in Regulatory Affairs (CMC focus), with a track record of supporting marketed products and/or clinical development of radiopharmaceuticals
• Familiarity with PET production, automated synthesis (cassette-based systems), and GMP requirements for radiolabeled compounds

Desired Characteristics

• Prior regulatory agency interaction experience (e.g., query responses, scientific advice, deficiency letters)
• Experience of global regulatory affairs from the pharmaceutical and/or healthcare industry 
• Experience of regulatory project management and regulatory agency interactions
• Experience with Veeva RIM or other registration tracking tools.
• Ability to work across cultures/countries/sites.

#LI-DN1 #LI-REMOTE

For U.S. based positions only, the pay range for this position is $128,800.00-$193,200.00 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 Sta