Director, APAC, Regulatory Affairs, Hematology

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-110634, Japan R-110635, Singapore R-108238 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: People Leader All Job Posting Locations: Chiyoda, Tokyo, Japan 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 Regional Regulatory Leader Asia Pacific (AP) is a member of the Global Regulatory Affairs organization. The position resides in the AP region and is responsible for working with the local regulatory affairs departments, AP Integrated Value Teams, AP Therapeutic Area SLT and head office-based team members (e.g., C-ROSS Major Submissions) to define and implement the regional strategy for assigned products. The position is accountable for leading and providing regulatory strategic input for assigned TAs/products. The position is accountable for leading and providing region or country strategic 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. The position is responsible for consolidation of strategy and prioritization of AP countries, including Japan and China that are aligned with business and R&D objectives. The position also ensures (either directly or through a partnership with C-ROSS Lifecycle Submission team) that product variations, including labeling changes, supplements, amendments, product license renewals are effected in the region. Furthermore, 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. This support includes J&J global products as well as licensed products (global, regional, local) and regional/local developed products. Position will ensure that interactions with local/regional manufacturing sites are managed. Position will also manage interactions with manufacturing sites as required to ensure the availability of proper standard export packaging components for product registration. Position will work with regulatory policy professionals as well as local affiliates to keep track of changes in country regulatory requirements and provide regulatory intelligence to regional management and head office. These activities would also include the support to regional and local implementation of strategies (e.g., generics, biosimilars, etc). Position will oversee/ensure adequate preparation for health authority meetings, and will need to attend and provide presentations to health authorities, where necessary. Directs Managers and/or senior individual contributors in a matrix environment, and is accountable for meaningful career development conversations and regular coaching and feedback. Responsible for managing operational aspects of their teams (e.g., budget, performance, and compliance), as well as implementing workforce and succession plans to meet business needs. Proactively creates a purpose driven environment by aligning Johnson & Johnson’s Credo and Leadership Imperatives with the strategies and goals of the team and enterprise. PRINCIPAL RESPONSIBILITIES for Regional Regulatory Leader – AP Provides direction for the activities related with assigned TA/products. Works with regional management, head office-based team members (e.g., C-ROSS Major Submissions) and local operating companies to define and implement the regional and local strategy for assigned TA/products. Is accountable for the development of the regional regulatory strategy and ensures the 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 Ensures consolidation of strategy and prioritization of AP countries, including Japan, China, North Asia clusters, Australia/New Zealand, and India/Southeast Asia clusters, that are aligned with business and R&D objectives. 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. Makes sure the appropriate participation of AP RLs as a standing member of the project related GRT; supports the GRT by providing strategic regional input into compound development, registration and life cycle management. Develops a deep understanding of the regional regulatory environment, competitor intelligence and therapeutic area. Expedites commercialization of new products, new indications and line extension via participation in the AP Integrated Value Teams, AP Therapeutic Area SLT to provide early regional regulatory inputs to identify barriers and needs to shape global developmental plan. 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 that staff is 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 relationship with key stakeholders including staff in the region and global R&D partners (e.g., GRTs, CDTs). 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 assist operating company wit