The Senior Regulatory Manager provides CMC regulatory input and strategies to directly support development projects and marketed products within Pharmaceutical Diagnostics. The key responsibility of Senior Regulatory Manager is to develop and maintain the Quality sections of the product dossiers throughout the entire life cycle of a product (Module 2.3 and Module 3). The Senior Regulatory Manager provides CMC regulatory input and strategies to directly support development projects and marketed products within Pharmaceutical Diagnostics. The key responsibility of Senior Regulatory Manager is to develop and maintain the Quality sections of the product dossiers throughout the entire life cycle of a product (Module 2.3 and Module 3). GE HealthCare is a leading global medical technology and digital solutions innovator. To provide CMC related strategic 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. In conjunction with the Global Regulatory Lead (GRL), 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. Review and, if necessary, write and edit individual CMC submission documents/CMC dossier sections to support regulatory submissions. 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. In support of key brand CMC variations,



proactively provide CMC related regulatory advice and assessment of impact to product dossiers. Advise project teams accordingly. Bachelor's Degree and 6+ years of experience. Experience in a diagnostic, pharmaceutical, or medical device industry. Capable of applying analytical skills in a CMC regulatory environment. Demonstrated knowledge & experience in scientifically related field e.g. pharmaceutical sciences, chemistry and analytical sciences. Experience in electronic document management and Quality management systems. Knowledge of international CMC regulatory requirements. Master's Degree Experience in pharmaceutical CMC regulatory or QA environment particularly with experience with injectable diagnostic or pharmaceutical products. Has the capability to influence managers and help drive decisions at a project level. 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 perks 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. 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. 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

📌 Senior Regulatory Affairs Manager, Chemistry Manufacturing and Controls (Canada)
🏢 GE Healthcare
📍 Canada