Manager, Regulatory Affairs, APAC

Manager, Regulatory Affairs, APAC Johnson & Johnson Innovative Medicine is seeking a Manager, Regulatory Affairs to join the Regulatory Affairs APAC team. The role is part of the Global Regulatory Affairs organization, based in the AP Region, and works with local regulatory affairs departments, AP regional cross‑functional teams, Global Regulatory Teams, and other global functions to define and implement regional strategy for assigned products. Job Description The position, under minimal supervision, is accountable for leading strategic input into the global regulatory strategy and identifying regional requirements to optimize registration and lifecycle management of marketed products. It provides timely responses to Health Authority enquiries and gives general regulatory support to all AP affiliates for the pharmaceutical sector business. Responsibilities Understands regional and local requirements and advises the Global Regulatory Team (GRT) and Compound Development Team (CDT) on applicable regulatory requirements, guidelines and processes. Participates as a standing member of the project‑related GRT and supports strategic regional input into registration and life cycle management. Expedites commercialization of new indications and line extensions by identifying barriers and needs. Provides guidance to local affiliates on accelerating submissions/approvals and on labeling changes. Maintains expert knowledge in regional regulatory requirements and ensures staff expertise. Provides AP evaluation in licensing activities. Manages regulatory interactions with local operating companies and regional functions, serving as point of contact. Ensures collaborative relationships with key stakeholders and facilitates discussions on regulatory issues. Provides input to submission tactical planning, maintains content plans for submissions, coordinates post‑approval submissions, reviews critical documents, and delivers on business‑critical regulatory submissions. Participates in “Rapid Response Teams” and ensures timely responses to HA questions. Tracks submission and approval milestones and post‑approval commitments. Participates in department process development and communicates key regulatory product activities and milestones. Updates global regulatory staff on regional regulatory changes and supports VP, Regulatory Affairs AP as requested. Required Technical Competencies and Knowledge Good understanding of the pharmaceutical industry and of local laws, regulations and guidance. Experience in drug development and/or marketed products. Ability to anticipate and influence regulatory developments and assess business impact. Understanding of scientific and medical principles applicable to therapeutic area and products. Awareness of pricing and reimbursement issues in AP. Knowledge of supply chain decisions and their impact on registrations. HA and Operating Company Interactions Detailed knowledge of HA structures and interaction strategies. Ability to influence HA actions and outcomes. Broad understanding of scientific data (CMC, clinical and non‑clinical). Submissions Knowledge of laws, regulations and guidance for regional submissions. Understanding of dossier components and timelines. Ability to analyze reports for regulatory compliance. Labeling Knowledge of local labeling requirements. Critically reviews labeling development/revisions and assesses impact. Opens negotiations with health authorities. Decision Making and Problem‑Solving Operates in a competitive, complex, and rapidly changing environment. Makes proposals and negotiates prioritization on a project level. Defines operational priorities and resolves conflicts with stakeholders. Determines risk‑management strategies and makes informed decisions. Independence/Autonomy Operates independently with limited managerial oversight. Sets long‑term priorities in consultation with supervisor. Knowledge, Education, Experience, Communication Skill Requirements Minimum bachelor’s degree or equivalent in pharmacy, life‑science, or health‑related discipline. 6‑10 years of relevant pharmaceutical industry experience, preferably with regulatory experience. Hands‑on experience in product registration in AP countries and preparation of health authority submissions. Demonstrated organizational skills and ability to handle multiple projects. Excellent verbal and written communication skills; proficiency in English and preferred Mandarin/Asian languages. Ability to work in a matrix environment and adapt to changing regulatory environment. Proficient use of MS Office and Internet resources. Travel may be required (1–2 times per year for regional business). Flexible hours for international meetings. Referrals Referrals increase your chances of interviewing at Johnson & Johnson Innovative Medicine by 2x. Get Notified Get notified about new Regulatory Affairs Manager jobs in Kowloon, Hong Kong SAR. #J-18808-Ljbffr