Director, APAC, Regulatory Affairs, Immunology
Johnson & JohnsonAt 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. Whether you apply to one or all of these requisition numbers, your applications will be considered as a single submission.
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.
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 provides strategic leadership input for the local regulatory affairs department in Asia Pacific and implements regional and local regulatory strategy for products and projects in the assigned therapeutic area. It provides region or country input into global regulatory strategy and identifies regional requirements for successful regulatory filings for new products and indications, including opportunities to place clinical trials within the region. It also provides leadership and portfolio review for early portfolio assets before they enter pivotal Phase 3 studies.
The position provides leadership with the local RA team to ensure adequate preparation for health authority meetings, and attends and presents to health authorities where necessary. It provides technical expertise to guide the development and understanding of new diseases for the local regulatory affairs team and extended team. It provides high-level oversight for product variations, including labeling changes, supplements, and amendments; timely responses to Health Authority inquiries; and regulatory support to affiliates in the region for the pharmaceutical sector business. The position resides in the Asia Pacific region.
The Director provides direction for regulatory activities related to products and projects in the Immunology therapeutic area, working with head-office liaisons and local operating companies to define and implement regional and local strategies. The Director manages development and implementation of multinational and 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.
The Director expedites regulatory approval of new products, indications, and line extensions through participation in regional cross-functional teams, providing early regional regulatory input to identify barriers and needs and shape global development plans. The Director provides technical expertise and guidance to local affiliates on strategies to accelerate submissions and approvals; provides input into labels and TPP; leads strategic discussions on labeling before and after registration; provides regional implementation and regulatory advice on new and updated Company Core Data Sheets; and maintains expert knowledge of regional regulatory requirements while ensuring staff expertise in country- and product-specific requirements.
The Director manages regulatory interactions with local operating companies and regional functions, serves as a point of contact with local operating companies, and ensures collaborative relationships with regional staff, R&D, business partners, and senior management. The Director interacts with local operating companies on individual products and processes, facilitates discussions on regional or global regulatory issues, guides operating companies on timing and strategy for regional Health Authority meetings, participates in preparations for Health Authority interactions, and assists operating companies during those interactions. The Director acts as the primary contact with multifunctional regional teams such as Commercial Strategic Marketing, Market Access, Supply Chain, Legal, and Patent, and leads regulatory activities on regional cross-functional teams.
The Director provides input to submission tactical planning and timelines, including lifecycle submissions such as labeling changes, renewals, and safety reports; maintains content plans for regional submissions, including clinical trials and registration submissions; reviews and provides input to critical submission documents; and delivers business-critical regulatory submissions according to development and post-marketing priorities and timelines. The Director may participate in Rapid Response Teams to ensure appropriate and timely responses to Health Authority questions, clarifies questions, and provides input to response strategies. The Director tracks submission and approval milestones and regional post-approval commitments and ensures appropriate follow-up actions with the C-ROSS MS team.
The Director has people-management and oversight responsibilities for regional regulatory staff and regulatory staff in local operating companies, as applicable; provides coaching and guidance to department and local affiliate regulatory staff; and supports talent development through strategy development, mentoring, and fostering talent.
Additional responsibilities include membership of the Asia-Pacific leadership team; management of regional in-licensed registration submissions; participation in development of department processes and procedures; ensuring processes are implemented within the regional regulatory office to track and communicate key regulatory product activities; updating HQ regulatory staff on changes in regional regulatory requirements and seeking to shape a favorable regulatory environment through industry groups; and supporting the Regional Head in developing regional metrics.
The role requires expert applied technical knowledge, leading business acumen, expert decision-making and prioritization, leading external focus and leadership and influencing, and expert persuasive communication. The Director operates independently in a complex environment with very limited managerial oversight, sets long-term work priorities in consultation with the supervisor and regulatory liaison team leader, and determines routine work issues. The Director reports to the Senior Director, Regional Regulatory Immunology Head and has direct line supervisory responsibility.
The Director works with Global Regulatory Affairs colleagues, local regulatory staff, and regional integrated value and cross-functional teams, including Commercial, Market Access, Supply Chain, Medical Affairs, GCO, Communications, and other regional teams. The position is located in the Asia Pacific region, requires flexible hours to accommodate early morning or late evening meetings and teleconferences across time zones, and requires 20–30% regional business travel.
EN: BusinessJP: Not Required
Mercari
