Regulatory Affairs Manager, Asia

About the role

PRODUCT COMPLIANCE TO LOCAL REGULATIONS: - Manage the regulatory activities across Southeast Asia region - regulatory submissions, ensure compliance for new or existing products. - Develop and implement regulatory strategies to ensure compliance with all relevant laws, regulations, and guidelines. - Manage the preparation of regulatory submissions, including product registrations, licenses, and approvals for new and existing products. - Draft, revise and review the relevant submission documents. - Provide regulatory guidance for the labelling, formula compliance, advertising and marketing of new and existing products across Southeast Asia region sales channels. - Conduct regulatory assessments and evaluations of product formulations, labelling, and promotional materials to ensure compliance. - Review raw material and ingredient compositions for regulatory conformity based on industry guidelines. - Participate in the design of new product launches by providing regulatory expertise on product formulation, package design, labelling, and claims development, etc. - Create and/or update document standard operating procedures regulatory activities. - Develop and implement procedures for creating, reviewing and approving labels to ensure consistency in labelling in the Southeast Asia markets. - Support product notifications as per business needs ensuring supply continuity. MANAGING EXTERNAL REGULATORY/ GOVERNMENT BODIES/ CUSTOMS: - Provide responses to regulatory agencies regarding product information or issues. - Assist with activities such as audits, regulatory agency inspections, or product recalls. - Develop relationships with various regulatory agencies, as required. - Assist with investigations relative to product complaints and prepare documentation and submissions to appropriate regulatory agencies as necessary. - Manage and track labelling projects across Southeast Asia region, including a system to provide access to important documents to external stakeholders. - Assist in creation of responses to regulatory agencies regarding product information or issues. - Securing documentation from various government agencies across the Southeast Asia region on an as needed basis. - Create product certificates and product documentation for product notification/registration where necessary. - Act as a HSA Agent for a foreign establishment to (a) review, disseminate, route, and respond to all communications from HSA including emergency communications; (b) respond to questions concerning those drugs that are imported or offered for import to HSA; (c) assist HSA in scheduling inspections; and (d) If HSA is unable to contact a foreign registrant directly or expeditiously, HSA may provide the information and/or documents to the HSA agent. HSA's providing information and/or documents to HSA agent is equivalent to providing the same information and/or documents to the foreign registrant. - Attend project meetings at early or late time of the day to accommodate external clients or internal customers located at different time zones. - Communicate with client/sponsor as needed. NEW PRODUCT INTRODUCTION SUPPORT: - Involvement in project implementation from regulatory perspective for new product introductions. - Support relevant team on creating new product pipelines and launches products according to project timelines. - Work closely with cross functional teams to ensure required documentation and compliance evaluations are in place for successful product registration/notification and launch. - Provide regulatory guidance to departments or development project teams regarding appropriate subjects. CONTINUOUS IMPROVEMENT: - Stay abreast of changes in regulatory requirements and industry trends to proactively advise the company on regulatory matters. - Maintain current knowledge of relevant regulations, including proposed and final rules. - Provide training session to the global RA team of Southeast Asian Regulations related to drug registration. - Maintain good relationship with other functional departments. - Key Challenges and Success Measures Customer, Stakeholders and Sourcing Site Regulatory Collaboration: Communicate regulatory information to cross-functional teams and ensure that information is interpreted correctly. - Extend support to customers in case of product clearance/customs as needed. - Provide accurate, risk-based approach to regulatory queries. - Positively add to the culture of the organization and participate across the broad spectrum of activity the function is responsible for to deliver on the total organizational goals. - Responsive to stakeholders. - Assist routine management of RA department or temporary works assigned by RA Director. REQUIREMENT: - Familiarity with relevant regulatory guidelines and standards. - Possess good knowledge of local and Southeast Asia regulations, inclusive HSA, USFDA, TGA, etc guidance. - Good interpersonal and communication skil

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