Manager, Regulatory Affairs, APAC

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

Job Function
Regulatory Affairs Group

Job Sub Function
Regulatory Affairs

Job Category
Professional

All Job Posting Locations
Mongkok, Kowloon, Hong Kong; North Ryde, New South Wales, Australia; Petaling Jaya, Selangor, Malaysia; Seoul, Korea, Republic of; Singapore, Singapore; Taipei City, Taiwan

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. The position, under minimal supervision, is accountable for leading and providing region or country strategic input into the global regulatory strategy and identifying regional requirements to optimize registration and lifecycle management of marketed products, taking into consideration current and proposed changes in regulatory requirements and standards. This position provides regional affiliates with timely responses to Health Authority enquiries and gives general regulatory support to all affiliates in the region for the pharmaceutical sector business.

• Regulatory Strategy and Expertise: Understands regional and local requirements and advises the Global Regulatory Team (GRT) and Compound Development Team (CDT) on applicable regulatory requirements, guidelines and processes, region-specific regulatory issues with impact on the product strategy or deliverables. Keeps up-to-date on understanding of regional/regulatory environment.
• Participates as a standing member of the project related GRT if applicable; supports the GRT by providing strategic regional input into registration and life cycle management.
• Expedites commercialization of new indications and line extension 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 staff are 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 partners. Interacts with local operating companies on individual products/processes. Facilitates discussions on regional or global regulatory issues, and provides guidance on timing and strategy for regional HA meetings. Participates in preparations for interactions with HAs and assists operating companies with these interactions.
    • Regulatory Submissions: Provides input to submission tactical planning and timelines including lifecycle submissions (labeling changes, renewals and safety reports). Maintains generic content plans for submissions in the region, including clinical trials and registration submissions. Coordinates post-approval submissions to ensure ongoing compliance. Reviews and provides input to critical submission documents. Delivers on business-critical regulatory submissions in line with development and post-marketing priorities and timelines. Participates in Rapid Response Teams to address HA questions and strategize responses. Tracks submission and approval milestones and regional post-approval commitments.
      • Additional Responsibilities: Participates in the development of department processes and procedures. Ensures defined processes are implemented within the regional regulatory office to track and communicate key regulatory product activities and milestones. Updates global regulatory staff on changes in regional regulatory requirements and provides support to VP, Regulatory Affairs AP on initiatives as requested.
      Qualifications
      • Minimum of bachelor's degree or equivalent in pharmacy or life-science or health-related discipline.
      • 6-10 years of overall experience in the pharmaceutical industry and preferably regulatory experience.
      • Hands-on experience in pharmaceutical product registration in AP countries and familiarity with AP regulatory systems and product registration requirements preferred. Experience in preparing documents for health authority submissions (Chemistry & Manufacturing, and/or Registration dossiers) preferred.
      • Demonstrated ability to handle multiple projects and strong organizational skills.
      • Ability to communicate to senior level management and working knowledge of regulations in the region.
      • Experience in HA interactions.
      • Excellent verbal and written communication skills – proficiency in written and oral English; Mandarin/Asian languages preferred.
      • Ability to develop and maintain excellent working relationships; able to work in a team environment and as an individual contributor.
      • Cultural sensitivity and ability to work in a multi-cultural, matrix environment; proactive, flexible, and able to adapt to changing regulatory environments.
      • Proficient use of MS Office and Internet resources.
      • Minimal regional travel (1-2 times per year); occasional international travel may be required. Flexible hours to accommodate time zones.
      Seniority level
      • Not Applicable
      Employment type
      • Full-time
      Job function
      • Legal
      Industries
      • Pharmaceutical Manufacturing

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