GE Healthcare is a subsidiary of American multinational conglomerate General Electric incorporated in New York and headquartered in Chicago, Illinois. As of 2017, it is a manufacturer and distributor of diagnostic imaging agents and radiopharmaceuticals for imaging modalities used in medical imaging procedures.
Post : Regulatory Affairs Manager
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.
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
• 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.
• 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
Experience : 5 years
Qualification : B.Pharm
Location : Gurgaon, Haryana ; Bengaluru, Karnataka, India
Industry Type : Pharma/ Healthcare/ Clinical research
End Date : 5th August, 2022
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