Senior Regulatory Affairs Manager, Chemistry Manufacturing and Controls

Job Description SummaryThe 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. Our mission is to improve lives in the moments that matter. Unlock your ambition, turn ideas into world-changing realities, and join an organization where every voice makes a difference, and every difference builds a healthier world.Job DescriptionKey Responsibilities includeTo 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. Review and approve published output.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.To support QA during audits and inspections as required.To keep oneself updated on CMC related guidelines.Qualifications/RequirementsBachelor's Degree and 6+ years of experience.Experience in a diagnostic, pharmaceutical, or medical device industry. Ability to prioritize, plan & evaluate deliverables to established strategic goals.Demonstrated experience of operating in a highly-regulated environment. 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.Desired CharacteristicsMaster's DegreeExperience in pharmaceutical CMC regulatory or QA environment particularly with experience with injectable diagnostic or pharmaceutical products.Has experience working within a matrix organization and has strong interpersonal and influencing skills to work across disciplines. Has the capability to influence managers and help drive decisions at a project level.Experience with Veeva RIM or other registration tracking tools.Demonstrated experience of prioritizing conflicting demands from multiple business entities in an extremely fast paced environment.Strong problem solving and negotiation skills.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 $106,400.00-$159,600.00 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 InformationGE 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: NoApplication Deadline: November 21, 2026Job SummaryJob number: R4047379Profession: Quality