Manager, Regulatory Affairs, APAC

Job Title: Manager, Regulatory Affairs – Regulatory Affairs APAC Job Function Regulatory Affairs Group Job Sub Function Regulatory Affairs Job Category Professional Locations Mongkok, Kowloon, Hong Kong; North Ryde, New South Wales, Australia; Petaling Jaya, Selangor, Malaysia; Seoul, South Korea; Singapore; Taipei City, Taiwan Job Description Johnson & Johnson is seeking a Manager, Regulatory Affairs to join the Regulatory Affairs APAC team. The Manager, Regulatory Affairs is a member of the Global Regulatory Affairs organization. The position resides in the AP Region and is responsible for working with local regulatory affairs departments, AP regional cross‑functional teams, Global Regulatory Teams and other global functions to define and implement the regional strategy for assigned products. Under minimal supervision, the Manager leads and provides regional or country strategic input into the global regulatory strategy, identifies regional requirements to optimize registration and lifecycle management of marketed products, and ensures timely responses to Health Authority enquiries and general regulatory support for all affiliates in the region for the pharmaceutical sector business. Responsibilities Regulatory Strategy and Expertise Understands regional and local requirements and advises the Global Regulatory Team and Compound Development Team on applicable regulatory requirements, guidelines, processes, and region‑specific issues impacting product strategy. Participates as a standing member of the project‑related GRT, supporting the GRT with strategic regional input into registration and lifecycle management. Expedites commercialization of new indications and line extensions by providing regional regulatory inputs to identify barriers and needs. Provides guidance to local affiliates on development of strategies to accelerate submissions/approvals. Provides input in post‑registration activities, including labeling changes. Provides regional implementation and regulatory‑based advice on new and updated Core Data Sheets. Maintains expert knowledge in regional regulatory requirements and ensures that staff is expert in country and product‑specific regulatory requirements. Provides AP evaluation in licensing activities. Health Authority, Operating Companies, and Business Partner Interactions Manages regulatory interactions with local operating companies and regional functions. Serves as point of contact with local operating companies. Ensures excellent collaborative relationships with key stakeholders, including staff in the region and global R&D partnersli> Interacts with local operating companies on individual products/processes and facilitates discussions on regional or global regulatory issues. Provides guidance to local operating companies to determine timing and strategy for regional HA meetings and assists with HA interactions. Regulatory Submissions Provides input to submission tactical planning and timelines, including lifecycle submissions (labeling changes, renewals, and safety reports). Ensures maintenance of generic content plans for submissions in the region, including clinical trials and registration submissions. Coordinates and follows up on post‑approval submissions to ensure product compliance. Reviews and provides input to critical submission documents. Delivers on business‑critical regulatory submissions according to development and/or post‑marketing priorities and timelines. Participates in “Rapid Response Teams” to provide timely responses to HA questions and clarifies HA queries while shaping the strategy for HA interactions. Tracks submission and approval milestones. Tracks regional post‑approval commitments and ensures appropriate follow‑up actions. Additional Responsibilities Participates in the development of department processes and procedures, ensuring defined processes are implemented to track and communicate key regulatory product activities and milestones. Updates global regulatory staff regarding changes in regional regulatory requirements and supports the VP, Regulatory Affairs AP as requested on initiatives. Required Technical Competencies And Knowledge Regulatory Strategy Good understanding of the pharmaceutical industry. Detailed knowledge of local laws, regulations, and guidance in the region related to the full drug lifecycle. Understanding of how laws, regulations, and guidance apply to specific projects and ability to interpret them. Experience in drug development and/or marketed products. Ability to anticipate and influence regulatory developments in the region and assess business impact. Ability to communicate AP regulatory strategy to global teams and assess impact on global/regional development. Understanding of scientific and medical principles applicable to therapeutic areas and specific products. Awareness of pricing and reimbursement issues in AP. Understanding of how supply chain decisions impact registrations in AP. HA And Operating Company Interactions Detailed knowledge of HA structures, operating procedures, and interaction strategies. Ability to influence HA actions and outcomes. Project‑related knowledge of commercial/medical business needs. Broad understanding of scientific data (CMC, clinical, and non‑clinical). Regulatory input into other functions and understanding of regional business partner needs. Submissions Detailed knowledge of laws, regulations, and guidance for regional submissions. Knowledge of dossier requirements and timelines. Ability to analyze reports for regulatory compliance and consistency with regional strategy. Labeling Knowledge of local labeling requirements. Ability to critically review labeling developments/revisions and assess impact on relevant countries. Knowledge of competitive landscape and similar labeling issues. Ability to undertake labeling negotiations with health authorities. Decision Making and Problem‑Solving Operates in a competitive, complex, and rapidly changing environment. Proposes and negotiates prioritizations and trade‑offs at the project level. Can make independent decisions within approved boundaries. Sets operational priorities and tactics in the region and resolves conflicts with internal partners. Determines risk‑management strategies for projects. Makes informed decisions by soliciting input from others when needed. Handles complex decisions in situations with multiple, ambiguous objectives and constraints. Independence/Autonomy Operates independently in a complex environment with limited managerial oversight; sets long‑term priorities with supervisor consultation and determines routine work issues. Knowledge, Education, Experience, Communication Skill Requirements Minimum of a bachelor’s degree or equivalent in pharmacy, life science, or health‑related discipline. 6‑10 years of overall experience in the pharmaceutical industry, preferably with regulatory experience. Hands‑on experience in pharmaceutical product registration in AP countries and familiarity with AP regulatory systems and product registration requirements. Experience preparing documents for health authority submissions (Chemistry & Manufacturing or Registration dossiers). Demonstrated ability to handle multiple projects and organizational skills. Ability to communicate with senior level management. Working knowledge of regulations in the region. Experience in HA interactions. Excellent verbal and written communication skills – proficiency in written and oral English and preferred Mandarin/Asian languages. Strong teamwork and individual contributor skills, cultural sensitivity, and ability to thrive in a multi‑cultural environment. Proactive team player with high flexibility and adaptability to a changing regulatory environment. Proficiency with MS Office and online resources. Minimal regional travel required (1‑2 times per year); occasional international travel may be required. Flexibility to accommodate early morning, evening meetings, and teleconferences across time zones. Preferred Skills Analytical Reasoning Business Writing Coaching Fact‑Based Decision Making Industry Analysis Legal Support Process Improvements Product Licensing Public Policies Regulatory Affairs Management Regulatory Compliance Regulatory Development Regulatory Environment Risk Assessments Risk Compliance Strategic Thinking Technical Credibility #J-18808-Ljbffr