Manager, APAC, Regulatory Affairs, Oncology

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. 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 Manager, APAC, Regulatory Affairs, Oncology 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 Compound teams, Global Regulatory Teams and head office-based team members (e.g., Regional Strategic Implementation Leader) to define and implement the regional strategy for assigned products. The position is accountable for leading and providing regulatory strategic input for assigned products. The position, under the supervision and supported by a supervisor, is responsible 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 within the oncology therapeutic area, including the opportunity for placement of clinical trials within the region. The position also ensures, either directly or through staff, that product variations, including labeling changes, supplements, amendments, and 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. The position will ensure that interactions with local/regional manufacturing sites are managed. The position will also manage interactions with manufacturing sites as required to ensure the availability of proper standard export packaging components for product registration. The 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. This support includes J&J global products as well as licensed products (global, regional, local) and regional/local developed products. The position, under the supervision and supported by a supervisor, will participate in the adequate preparation for health authority meetings, and may attend and provide presentations to health authorities, where necessary. PRINCIPAL RESPONSIBILITIES FOR REGIONAL REGULATORY MANAGER, ASIA PACIFIC Provides direction for the activities related to assigned products. Works with regional management, head office-based team members (e.g., Strategic Execution Leader), and local operating companies to define and implement the regional and local strategy for assigned products. Under the supervision and supported by a supervisor, is responsible for the development of the regional regulatory strategy and ensures the implementation of multinational/regional regulatory 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 Understands regional and local requirements and advises the Global Regulatory Team (GRT) and Compound Development Team (CDT) on applicable regulatory requirements, guidelines and processes, and region-specific regulatory issues with impact on the product strategy or deliverables. Keeps up to date on the regional regulatory environment. Participates as a standing member of the project-related GRT; supports the GRT by providing strategic regional input into compound development, registration and lifecycle management. Expedites commercialization of new products, new indications and line extensions through participation in AP Compound teams, providing early regional regulatory input to identify barriers and needs and shape the global development plan. Provides guidance to local affiliates on development of strategies to accelerate submissions and 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 of regional regulatory requirements and ensures that staff are 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 relationships with key stakeholders, including staff in the region and global R&D partners. Interacts with local operating companies on individual products and 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 Health Authority meetings. Participates in preparations for interactions with Health Authorities and assists operating companies with these interactions. Acts as the primary contact with multifunctional regional teams such as the Asia Pacific Therapeutic Area Strategic Team, regional marketing, Alliance logistics and supply chain, and the trademark office in the US. Leads regulatory activities on AP Compound teams. Regulatory Submissions Provides input to submission tactical planning and timelines, including lifecycle submissions such as labeling changes, renewals and safety reports. Ensures maintenance of generic content plans for submissions in the region, including clinical trial and registration submissions. Coordinates and follows up on post-approval submissions to ensure that products remain in compliance. Reviews and provides input to critical submission documents. Delivers business-critical regulatory submissions in accordance with development and/or post-marketing priorities and timelines. Participates in Rapid Response Teams to ensure appropriate and timely responses to Health Authority questions. Provides clarification regarding Health Authority questions and input to the response strategy. Ensures tracking of submission and approval milestones. Ensures tracking of regional post-approval commitments and appropriate follow-up actions. Additional Responsibilities Responsible for management of regional in-licensed registration submissions, including drafting the regulatory aspects of the license agreeme