Job title: Regulatory Affairs Manager
Company: General Electric
Job description: Job Description Summary This role will be part of Regulatory Affairs CMC (Chemistry, Manufacturing and Control). In this role, you will provide strategic Regulatory CMC guidance and input in support of development projects and marketed products withi
Job Description Summary This role will be part of Regulatory Affairs CMC (Chemistry, Manufacturing and Control). In this role, you will provide strategic Regulatory CMC guidance and input in support of development projects and marketed products within Pharmaceutical Diagnostics (PDx). The key responsibility of Regulatory Affairs Manager CMC is to develop and maintain the Quality sections of the product dossiers throughout the entire life cycle of a product. 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 Description Key Responsibilities include: 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. Review and, 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. To support QA during audits and inspections as required. To keep oneself updated on CMC related guidelines Qualifications/Requirements Bachelor’s Degree & a minimum of 5 years of experience in a diagnostic or pharmaceutical industry or medical device or government / government relations. Knowledge of international CMC regulatory requirements Ability to prioritize, plan and evaluate deliverables to established strategic goals. Experience in electronic document management and Quality management systems. Ability to work well independently and in a team setting. Desired Characteristics Strong interpersonal skills and ability to engage effectively with colleagues at all levels Experience with Veeva RIM or other registration tracking tools. Ability to resolve day-to-day issues, escalating issues that impact strategic initiatives Experience working with outsource partners an advantage Inclusion and Diversity GE Healthcare is an Equal Opportunity Employer where inclusion matters. 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. We expect all employees to live and breathe our behaviors: to act with humility and build trust lead with transparency deliver with focus, and drive ownership – always with unyielding integrity. Our total rewards are designed to unlock your ambition by giving you the boost and flexibility you need to turn your ideas into world-changing realities. Our salary and benefits are everything you’d expect from an organization with global strength and scale, and you’ll be surrounded by career opportunities in a culture that fosters care, collaboration and support. #LI-MA3
Location: Bangalore, Karnataka
Job date: Sat, 16 Jul 2022 22:39:11 GMT
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