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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.

Roles and Responsibilities

Serve as the regulatory CMC strategy point of contact for project teams and provide CMC‑related regulatory input for assigned projects/products.

Build or provide input to submission strategy documents by defining supplement type, required data, and submission documents for the package.

Guide the project team in the planning phase so that correct data (and level of detail) for all markets is collected and submitted.

Author and review individual CMC submission documents/dossier sections to support regulatory submissions.

Provide consistent expert advice to the organization, determining feasible regulatory strategies and identifying potential options to deliver optimal business value or mitigate compliance issues.

Maintain registration tracking information and assist in the development of good document management practice standards.

Work closely with global RA and regional RA’s to address questions from regulatory authorities.

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 or Quality, with a track record of supporting marketed products and/or clinical development of radiopharmaceuticals.

Desired Characteristics

Familiarity with PET production, automated synthesis (cassette-based systems), and GMP requirements for radiolabeled compounds.

Experience with regulatory submissions for post-approval changes, including FDA supplements and EU variations.

Ability to prioritize, plan & evaluate deliverables to established strategic goals for complex projects, including scientific discussions on how best to present information. Strong problem-solving and negotiation skills.

Demonstrated experience of operating in a highly regulated environment. Capability to apply analytical skills in a CMC regulatory environment.

Experience working within a matrix organization with robust interpersonal and influencing skills to work across disciplines. Ability to influence managers and help drive decisions at a project level.

Demonstrated knowledge & experience in scientifically related fields such as pharmaceutical sciences, chemistry, and analytical sciences.

Strong written and oral English to clearly and concisely present information to the relevant audience.

Experience in pharmaceutical CMC regulatory or QA environment, particularly with injectable diagnostic or pharmaceutical products. Ability to interpret global regulations and present to the wider business.





Experience in electronic document management and quality management systems.

Proactive champion of projects and experience mentoring team members.

Knowledge of international CMC regulatory requirements.

Strong interpersonal skills and ability to engage effectively with colleagues at all levels.

Prior regulatory agency interaction experience (e.g., query responses, scientific advice, deficiency letters).

Experience in global regulatory affairs from the pharmaceutical and/or healthcare industry.

Experience in regulatory project management and regulatory agency interactions.

Experience with Veeva RIM or other registration tracking tools.

Ability to work across cultures/countries/sites.

Experience prioritizing conflicting demands from multiple business entities in a fast‑paced environment.

Compensation and Benefits For U.S. based positions only, the pay range for this position is $132,000.00–$198,000.00 Annual. Compensation decisions are dependent on skills, qualifications, experience and location and may include performance‑based incentive compensation such as cash bonus(es) and/or long‑term incentives (LTI). GE HealthCare offers a competitive benefits package, including medical, dental, vision, paid time off, a 401(k) plan with employee and company contribution opportunities, life, disability, and accident insurance, and tuition reimbursement.

Equal Opportunity Employer 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.

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Apply on Kit Job: kitjob.ca/job/2g8qe3

📌 Associate Director, Regulatory Affairs, CMC (Charlottetown)
🏢 GE Healthcare
📍 Charlottetown