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Job Function:
Regulatory Affairs Group
Job Sub Function:
Regulatory Affairs
Job Category:
Professional
All Job Posting Locations:
Bangkok, Bangkok, Thailand
Job Description:
The Regulatory Affairs Specialist is responsible for all aspects of regulatory responsibilities in Thailand, Myanmar, Australia and New Zealand.This role blends regulatory strategy with hands-on submission management, labeling compliance, post-market surveillance, and cross-functional collaboration to ensure timely market access and ongoing conformity with local requirements.Additionally, this role is responsible for directing post-marketing Lifecycle Management (LCM) Regulatory activities (e.g., claims, change management, re-registrations, copy clearance, global LCM labeling support, and external environment surveillance).
Responsibilities
Directs both growth/innovation and post-marketing Lifecycle Management (LCM) Regulatory activities (e.g., claims, change management, renewals, copy clearance, global LCM labeling support, and external environment surveillance). Oversees the creation of global regulatory product development strategies and preparation/submission of marketing approval applications to health authorities to ensure that development plans meet global regulatory requirements. Ensure compliance with product post-marketing approval requirements. Develop and advance the organization’s policy and procedures for regulatory affairs and compliance to establish a compliant culture.
Interacts with internal, health authorities and global regulatory personnel to resolve regulatory matters ranging from pending application negotiations to proposed legislation and guidance document ramifications for the business
Assess the acceptability of documentation for submission filing to comply with regulatory requirements for clinical trials, marketing applications and corporate goals, to secure submission approval. Identify and implement new regulatory policies, processes and SOPs, as appropriate.
Participate in new product development teams to provide input and expertise on regulatory requirements, determination of global regulatory strategies, review and approval of documentation to support regulatory submissions worldwide.
Monitor and assess impact of changing regulations on submission strategies.
Provides strategic direction and advice regarding regulatory pathways and timelines.
Evaluate proposed preclinical, clinical and manufacturing changes for regulatory filing strategies.
Provide medical review and assure compliance of promotional materials in accordance with approved labelling, application regulations and industry standards
Participate in local industry/trade association meetings
Performs additional duties as assigned.
Required Knowledge, Skills and Abilities:
Expert knowledge and application of principles, concepts, and practices related to regional governmental regulations.
Strong understanding of regulatory and business strategies to achieve and maintain legal marketing status for product portfolios.
Excellent organizational, communication, negotiation, and interpersonal skills.
Proven ability to negotiate and influence health authorities to align regulatory and business objectives.
Familiarity with ASEAN Medical Device Directive (MDD).
Experience in new product registration and renewal of medical device registrations (manufacturer or distributor) is an advantage.
Required Skills:
Preferred Skills:
Analytical Reasoning, Business Behavior, Business Writing, Collaborating, Communication, Confidentiality, Data Reporting, Data Savvy, Detail-Oriented, Execution Focus, Legal Support, Medicines and Device Development and Regulation, Regulatory Affairs Management, Regulatory Compliance, Regulatory Development, Regulatory Environment, Risk Assessments
