Johnson & Johnson (Hong Kong) Ltd 香港招聘
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com
Business Unit Head – Oncology
Purpose:
The Business Unit Head – Oncology is responsible for leading the overall strategy, execution, and performance of the Oncology business in Hong Kong, including Macau and Business Development initiatives.
This role drives sustainable growth by shaping differentiated strategies, strengthening organisational capabilities, and delivering commercial excellence across marketing and sales. As a key member of the leadership team, the role builds high-performing teams, fosters a culture of innovation and inclusion, and ensures full compliance in a dynamic regulatory environment.
You will be responsible for:
Defining and executing the overall Oncology business strategy, delivering sustainable growth through strong brand performance and effective portfolio management
Leading and aligning sales and marketing teams to develop and implement robust strategic and tactical plans that maximise product and portfolio value
Owning Business Development strategy, including identification, evaluation, and execution of partnerships, licensing opportunities, and portfolio expansion
Driving data-driven decision-making through deep analysis of market trends, competitive landscape, and evolving healthcare dynamics
Building and leading a high-performing organisation by attracting, developing, and retaining diverse talent while fostering a strong coaching culture
Maximising cross-functional and cross-geography collaboration to ensure seamless integration of commercial activities and portfolio execution
Establishing strong partnerships with key external stakeholders, including healthcare providers, KOLs, regulators, and industry bodies, translating insights into impactful strategies
Ensuring full compliance with legal, regulatory, and company standards while proactively managing risks and shaping a culture of integrity and accountability
Qualifications / Requirements:
Bachelor’s degree in Life Sciences, Business, or related field; advanced degree (MBA, MSc, PhD, or equivalent) is strongly preferred
Preferably minimum of 10 years of experience within the pharmaceutical industry, including senior/leadership roles in sales and marketing
Proven track record of successfully leading and growing a business unit, with strong P&L ownership and accountability
Demonstrated experience in business development, including partnerships, licensing, and strategic portfolio expansion
Strong financial acumen with the ability to evaluate investments, manage budgets, and optimise resource allocation
Deep understanding of the oncology landscape, including treatment trends, stakeholder ecosystem, and market access dynamics
Strong ability to operate within a matrixed organisation, influencing regional and global stakeholders and driving alignment beyond direct reporting lines
Inspirational and inclusive leadership style with a proven ability to build high-performing teams, develop future leaders, and foster a culture of diversity, equity, and inclusion
Manager, QARA Hong Kong
The Manager, QARA Hong Kong provides operational leadership for quality assurance and regulatory affairs supporting the Hong Kong market. This role is accountable for ensuring regulatory compliance, effective quality management system execution, and sustained market access for DePuy Synthes’ Orthopedics portfolio in a highly regulated environment.
This role plays a critical part in safeguarding patient safety, managing quality and regulatory risk, and enabling compliant business continuity and growth. The Manager partners closely with local market stakeholders, regional leadership, and Global QARA teams to support product lifecycle activities and operational excellence.
Key Responsibilities:
Lead and manage Quality Assurance and Regulatory Affairs activities to support product registrations, renewals, variations, and full lifecycle management for the Hong Kong market.
Ensure compliance with Hong Kong regulatory requirements, internal policies, applicable international standards, and DePuy Synthes quality management system expectations.
Serve as the primary QARA point of contact for Hong Kong Local Market Support.
Coordinate regulatory submissions, technical documentation, and responses to health authority inquiries in collaboration with Global QARA teams.
Partner with cross‑functional teams including Commercial, Operations, Supply Chain, Legal, and Global QARA to support business objectives and supply continuity.
Monitor regulatory, quality, and enforcement changes applicable to Hong Kong and assess potential impacts to products, portfolios, and operations.
Support and participate in regulatory inspections, quality audits, and compliance assessments as required.
Contribute to continuous improvement initiatives to enhance QARA efficiency, compliance consistency, and inspection readiness.
Qualifications
Education
Required: Bachelor’s degree in Regulatory Affairs, Life Sciences, Engineering, or a related discipline.
Preferred: Advanced degree or professional certification in Regulatory Affairs, Quality, or a related field.
Experience and Skills
Required:
6–8 years of progressive experience in Quality Assurance and/or Regulatory Affairs within the medical device, healthcare, or other regulated industries.
Strong working knowledge of regulatory requirements applicable to Hong Kong.
Experience managing product registrations and lifecycle activities in international markets.
Ability to interpret and apply regulatory and quality requirements to support business and product decisions.
Strong stakeholder management, communication, and cross‑functional collaboration skills.
Ability to manage multiple priorities in a complex, fast‑paced, and matrixed environment.
Preferred:
Experience multi‑market QARA portfolios.
Familiarity with global regulatory frameworks and harmonization initiatives.
Experience working in a multinational or matrixed organization.
Exposure to regulatory audits, quality audits, or health authority interactions.
Demonstrated experience contributing to regulatory or quality process improvement initiatives.
Regulatory Affairs or Quality certification (e.g., RAC or equivalent).
Other
Language: English required; Cantonese and/or Mandarin preferred.
Travel: Limited; primarily regional travel related to market support activities.
Certifications: RAC or equivalent preferred but not required.
Senior Regulatory Affairs Specialist
The Senior Regulatory Affairs Specialist (Hong Kong & Macao) is responsible for leading and executing regulatory activities to ensure compliance, timely product registrations, and lifecycle management of J&J Vision products in Hong Kong and Macao. This role provides regulatory expertise to support product registrations, renewals, promotional activities, and tendering, while ensuring alignment with local regulatory requirements, internal SOPs, and J&J quality standards.
Key Responsibilities:
Regulatory Submissions & Lifecycle Management
Lead and take ownership of regulatory dossier preparation for product registrations, renewals, and post‑approval changes in Hong Kong and Macao.
Be accountable for achieving high‑quality, on‑time approvals for new registrations and changes, and ensuring 100% on‑time renewals prior to license expiry in both markets.
Prepare, submit, and manage timely responses to regulatory authority questions and official correspondences.
Maintain accurate regulatory databases, trackers, and archives for all Hong Kong and Macao regulatory documentation.
Regulatory Compliance & Intelligence
Monitor, interpret, and assess changes in regulatory requirements, legislation, and guidance in Hong Kong and Macao relevant to J&J Vision products.
Provide regulatory impact assessment, clear interpretations, and practical compliance recommendations to internal stakeholders.
Ensure ongoing compliance of marketed products throughout their lifecycle in both markets.
Artwork, Labeling & Promotional Material Review
Review and approve artwork, labeling, packaging, and IFUs to ensure consistency with approved registrations and local regulatory requirements for Hong Kong and Macao.
Coordinate and support review and approval of promotional and educational materials in compliance with local regulations and internal review processes.
Business & Tendering Support
Support regulatory inputs for Hong Kong and Macao tendering activities, including review of regulatory sections, compliance statements, and supporting documents.
Act as the primary regulatory contact for product registration‑related inquiries from health authorities, customers, and internal teams in both markets.
Cross‑Functional Collaboration & Expertise
Work closely with commercial, quality, supply chain, PD, and regional/global RA teams to support product launches and business continuity in Hong Kong and Macao.
Serve as a regulatory subject matter expert for the HK & Macao markets.
Contribute to continuous improvement initiatives, including SOP updates, process optimization, and regulatory best‑practice sharing.
Required Qualifications & Experience
Bachelor’s degree or above in Life Sciences, Pharmacy, Biomedical Engineering, Regulatory Affairs, or a related discipline.
Solid experience in Regulatory Affairs for medical devices (and/or pharmaceuticals), with hands‑on responsibility for Hong Kong and/or Macao regulatory submissions.
Good understanding of regulatory frameworks and submission processes applicable to Hong Kong and Macao.
Proven ability to manage multiple regulatory projects with competing priorities.
Strong written and spoken English; Cantonese / Chinese proficiency preferred for local communications & material review.
Preferred Skills & Competencies
Regulatory Affairs Management & Regulatory Compliance
Product Licensing & Lifecycle Management (HK & Macao)
Regulatory Environment Assessment & Risk Evaluation
Analytical Reasoning & Problem Solving
Business & Regulatory Writing
Strong Communication & Stakeholder Management
Attention to Detail & Data Integrity
Confidentiality & Ethical Business Conduct
Teamwork & Cross‑Functional Collaboration
Preferred Skills:
Analytical Reasoning, Business Behavior, Business Writing, Communication, Confidentiality, Data Reporting, Detail-Oriented, Legal Support, Medicines and Device Development and Regulation, Problem Solving, Product Licensing, Regulatory Affairs Management, Regulatory Compliance, Regulatory Development, Regulatory Environment, Risk Assessments, Teamwork
