Director APAC Regulatory Affairs Immunology

JOHNSON & JOHNSON INTERNATIONAL (SINGAPORE) PTE. LTD.; Singapore; On-site; SGD 300,000 - 600,000; Full time

Job summary

Johnson & Johnson International (Singapore) Pte. Ltd. is seeking a Regulatory Affairs Director for Asia Pacific to lead regulatory strategy for Immunology products, including Nipocalimab, and to coordinate with global teams.

The role reports to the Therapeutic Immunology head and guides local RA activities, health authority interactions, and lifecycle management across the region. The successful candidate will provide strategic input on regional regulatory requirements, prepare for HA meetings,

Job description

The Regulatory Affairs Director is a member of the Global Regulatory Affairs organization and is the regulatory regional office for the Immunology portfolio reporting to the therapeutic immunology head. This product responsibility includes leadership responsibility for Nipocalimab and early portfolio. The position is required to provide strategic leadership input for local regulatory affairs department in Asia Pacific and successfully implement the regional and local regulatory strategy for products / projects in the assigned therapeutic area. The position is also responsible for providing region or country input into the global regulatory strategy and identifying regional requirements for successful regulatory filings for new products/indications, including the opportunity for placement of clinical trials within the region. This position is also required to provide leadership and portfolio review for all the early portfolio assets before going into pivotal Phase 3 study. This position also should provide leadership together with the local RA team to ensure adequate preparation for health authority meetings, and attend and provide presentations to health authorities, where necessary. As immunology is a therapeutic area with many new diseases, the technical expertise of the position to guide the development and understanding of new diseases for the local regulatory affairs team and extended team is also important. The position also needs to provide high-level oversight for product variations, including labeling changes, supplements, and amendments; timely responses to Health Authority inquiries; as well as regulatory support to all affiliates in the region for the pharmaceutical sector business. The position resides in Asia Pac region.

PRINCIPAL RESPONSIBILITIES for Regulatory Affairs Director, Asia Pacific

• Provides direction for the regulatory activities related to products / projects in the Immunology therapeutic area. Works with "head office-based liaisons" and local operating companies to define and implement the regional and local strategy for assigned products.
• Manages development and implementation of multi-national/regional regulatory and strategies that optimize development, registration, and lifecycle management of new and marketed products, taking into consideration current and proposed changes in regulatory requirements and standards.

Regulatory Strategy and Expertise

• Expedites Regulatory approval of new products, new indications and line extensions via participation in the regional cross functional team(s) to provide early regional regulatory inputs to identify barriers and needs to shape global developmental plan.
• Provides technical expertise and guidance to local affiliates on development of strategies to accelerate submissions/approvals
• Provides input into label and TPP, leads strategic discussion on label pre and post registration.
• Provides regional implementation and regulatory-based advice on new and updated Company Core Data Sheets.
• Maintains expert knowledge in regional regulatory requirements and ensures that staff is expert in country and product-specific regulatory requirements

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 relationship with key stakeholders including staff in the region, R&D and business partners, and senior management.
• Interacts with local operating companies on individual products/processes
• Facilitates discussions with local operating companies on regional or global regulatory issues, as required
• Provides guidance to local operating companies to determine timing and strategy for regional HA meetings. Participates in preparations for interactions with HAs and assists operating company with these interactions.
• Acts as the primary contact with multifunctional regional teams such as Commercial Strategic Marketing, Market access, supply chain, legal and patent
• Leads regulatory activities on regional cross functional teams

Regulatory Submissions

• Provides input to submission tactical planning and timelines including lifecycle submissions (labeling changes, renewals and safety reports).
• Ensures maintenance of content plans for submissions in the region, including clinical trials and registration submissions
• Reviews and provides input to critical submission documents.
• Delivers on business critical regulatory submissions in accordance with development and/or post marketing priorities and timelines.
• May be invited to participate in "Rapid Response Teams" to ensure appropriate and timely responses to HA questions. Provides clarification regarding HA questions and provides input to the strategy for responding to HA questions.
• Ensures tracking of submission and approval milestones
• Ensures tr