At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and Med Tech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow and profoundly impact health for humanity. Learn more at https://www.jnj.com. Job Function: Regulatory Affairs Group Job Sub Function: Regulatory Affairs Job Category: Professional All Job Posting Locations: Mongkok, Kowloon, Hong Kong Job Description: Implements compliance with regulatory agency regulations by providing knowledge to enable products that are developed, manufactured, or distributed to meet regulatory agency requirements. Completes thorough analysis and interpretation of scientific data in assessing risk and creating regulatory strategies to expedite new product introductions to the market. Applies in-depth knowledge on cross-functional project teams in the development of compliant policies and operational plans to ensure timely commercialization of new and modified products into key markets. Identifies opportunities for input on product labeling, claims support, promotional and scientific materials, and other related activities to ensure all regulatory requirements are met throughout the development process. Completes detailed regulatory submissions required for new and existing product approvals and registrations. Communicates Regulatory Affairs interpretation and feedback in support of federal, state, and international regulations by preparing documentation and reports to support internal and external audits. Coaches more junior colleagues in techniques, processes, and responsibilities. Understands and applies Johnson & Johnson's Credo and Leadership Imperatives in day-to-day interactions with the team.
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