Director, APAC, Regulatory Affairs, Immunology

Job description

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 jnj.com. As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit. Please note that this role is available across multiple countries and may be posted under different requisition numbers to comply with local requirements. While you are welcome to apply to any or all of the postings, we recommend focusing on the specific country(s) that align with your preferred location(s): China R-108931, Japan R-108932, Singapore R-107981 Remember, whether you apply to one or all of these requisition numbers, your applications will be considered as a single submission. Job Function: Regulatory Affairs Group Job Sub Function: Regulatory Affairs Job Category: Professional All Job Posting Locations: Beijing, China, Chiyoda, Tokyo, Japan, Singapore, Singapore Job Description: About Innovative Medicine Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow. Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way. Learn more at https://www.jnj.com/innovative-medicine POSITION SUMMARY: 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 tracking of regional post-approval commitments and ensures appropriate follow-up actions with C-ROSS MS team People Management Will have people management/oversight responsibilities for regional regulatory staff, and regulatory staff in LOCs, if applicable. Provides coaching and guidance to department and local affiliates’ regulatory staff as appropriate Participates in development of a strategy to ensure development of talent; supports, mentors, and fosters talent development. Additional Responsibilities: Member of the Asia-Pacific leadership team to support extended group for projects and development Responsible for the management of regional in-licensed registration submissions Participates in the development of department processes and procedures.  Ensures that defined processes are developed and implemented within the regional regulatory office to track and communicate key regulatory product activities Updates HQ regulatory staff regarding changes in regional regulatory requirements and seeks to shape a favorable regulatory environment thro