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 MedTech, 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 Product Submissions and Registration **Job Category:** Professional **All Job Posting Locations:** Mongkok, Kowloon, Hong Kong **Job Description:** Johnson & Johnson is seeking a Regulatory Management Centre (RMC) Submission Specialist to join the Regulatory Affairs team. Overall purpose of job + Develops skill set to enable value added individual contributions, who works under close supervision. Applies methods for planning, directing, coordinating and controlling regulatory affairs activities related to new and modified products worldwide in compliance with corporate policies and strategies. Interprets new and changing government regulations to ensure compliance with regulatory/ government standards. + Maintain regulatory compliance and system compliance. + Ensure training assignment is appropriate and timely. Key responsibilities RMC submission + Assists by providing knowledge in implementing compliance with regulations to enable products that are developed, manufactured, or distributed meet regulatory agency requirements. + Applies functional analysis and interpretation of scientific data in assessing risk and creating regulatory strategies to expedite new product introductions to the market. + Contributes 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. + Advises product development teams on input for product labeling, claims support, promotional and scientific materials, and other related activities to ensure all regulatory requirements are met throughout the development process. + Carries out the detailed regulatory submissions required for new and existing product approvals and registrations. + Coordinates Regulatory Affairs interpretation and feedback in support of federal, state, and/or international regulations by preparing documentation and reports to support internal and external audits. + Understands and applies Johnson & Johnson’s Credo and Leadership Imperatives in day-to-day interactions with team. Regulatory Compliance + Archive regulatory documents, maintain or support regulatory compliance metrics and training metrics, monitor HK & MO NCE registration status and adopting regulatory requirement (ARR) compliance for external changes, renew product licences. System Compliance + Manage regulatory documents or licences in systems, e.g. truVault, Corporate Entity Management System (CEMS) + Assign training according to LOC RA-related training matrix to other functions by SUMMIT Training System. Required Qualification + University degree in pharmacy,life sciencesor equivalent field. + 3 years or more relevant workexperience in Regulatory Affairs/ GovernmentAffairs/ Quality/ Compliance/ Manufacturing inmedical or pharmaceutical companies. Less work experience/ Fresh graduate maybe considered with title adjustment subject to work experience. + Experienceof working in a virtual team and/or global organization. + Previous experience in RA role as Associate,Professional or similar role is of advantage. + Knowledge of local regulationsand international standards. + Able to make independent decisions. + Able to analyze (complex) information and situations and to formulate clear solutions. + Constructive team player. + Good communication and collaboration skills are required Required Core Competencies: + Project management skill + Detail-oriented skill & Holistic view + AnalyticalskillwithtechnicalRAknowledge + Adaptability on acquiring local knowledge and shift between local situations + Communication skill with cultural sensitivity in working withstakeholders across markets + Collaboration & Team player + Proficient in English (includingtechnical RA English)