Specialist, Regulatory Management Centre (RMC) Submission

• 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.

• 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.

• 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.

• 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.

• University degree in pharmacy, life sciences or equivalent field.
• 3 years or more relevant work experience in Regulatory Affairs/ Government Affairs/ Quality/ Compliance/ Manufacturing in medical or pharmaceutical companies. Less work experience/ Fresh graduate maybe considered with title adjustment subject to work experience.
• Experience of 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 regulations and 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

• Project management skill
• Detail-oriented skill & Holistic view
• Analytical skill with technical RA knowledge
• Adaptability on acquiring local knowledge and shift between local situations
• Communication skill with cultural sensitivity in working with stakeholders across markets
• Collaboration & Team player
• Proficient in English (including technical RA English)

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