Senior Manager, 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. Job Function: Regulatory Affairs Group Job Sub Function: Regulatory Affairs Job Category: Professional All Job Posting Locations: 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 The Senior Manager, APAC, Regulatory Affairs, Immunology 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, Global Regulatory o define and implement the regional strategy for the assigned therapeutic leader The position is accountable for leading and providing region or country input into the global regulatory strategy to compound development teams, global regulatory teams, 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 a core member of the IVT (Integrated Value Team) and CFT (Cross functional Team) and responsible for the integrated product strategy in alignment with regional Strategic Marketing, MAF and Market access. The position is responsible for driving the long-term growth strategy and vision for regulatory affairs in the assigned TA. The position provides leadership and guidance in aligning regulatory affairs in the region to ensure synergy and integration among countries within the region and globally, and ensuring strategic input into product-related activities (development and lifecycle) and non-products activities (such as but not limited to processes, regulatory intelligence, competitor intelligence, generics, biosimilars) The position is also responsible for the management of staff under her/his responsibility The Sr Director Regulatory regional TA leader lead long-term regulatory initiatives to support and collaborate in the development of capabilitities in China or Japan She/he is also responsible for development long-term startegies to prepare the region for the future environment, beyond the assigned TA, representing regulatory affairs in global forums within CDTs, R&D and business functions. Position will oversee and ensure adequate preparation for health authority meetings, and will need to attend and provide presentations to health authorities, where necessary. And collaborate with other funtions (Governematl affairs, GRPI) in the analysis of regulatorions and influencing in the appropaite bodies PRINCIPAL RESPONSIBILITIES Provides direction and 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 He/she is an active member of the regional CFT/IVT working in the regional integrated product strategy along with MAF, Strategic Marketing, and Market Access. He/she is also responsible for the deployment of this strategy to LOCs. To ensure consolidation of strategy and prioritization of countries aligned with business and R&D objectives Expedites commercialization of new products, new indications and line extension via participation in the Regional Therapeutic Area Teams to provide early regional regulatory inputs to identify barriers and needs to shape global developmental plan within 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. Develop a deep understanding of the regional regulatory environment, competitor intelligence and therapeutic area. Provides guidance to local affiliates on development of strategies to accelerate submissions/approvals Participates 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. Provides input into strategy with respect to clinical data requirements and study design. Maintains expert knowledge in regional regulatory requirements and ensure 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 global/ regional functions Determines timing and strategy for meeting with regulatory agencies , and leads preparations for these meetings along with relevant regulatory and compound development team members and regional regulatory staff. Prepares global company personnel for interactions with HAs 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 with these interactions. Ensures excellent collaborative relationship with key stakeholders including staff in the region and R&D partners (e.g. GRTs, CDTs, APMS) Interacts with local operating companies on individual products/processes Leads regulatory activities on regional therapeutic area teams Regulatory Submissions Develop the TA strategy with direct report, GRT, IVT, CDT and R&D functional representatives, on required documents and processes to support HA contacts and submissions. Lead regulatory forums to provides strategic input to CTAs People Management Include people management Is co-responsible with VP regional Ap in the development of the staff and pipeline of people Provides coaching and guidance to department and local affiliates regulatory staff as appropriate Additional Responsibilities: Long-term multi-function and/or x-sector initiative with high impact in the AP region Required Leadership Competencies: Credo - Demonstrate and inspire the behaviors that reinforce Our Johnson & Johnson Credo. Connect – Develop deep insights into the needs of our patients,customers, markets and communities. Shape – Drive innovation; anticipate and shape industry and market changes to advance health care globally. Lead – Create an environment where leadership and talent development is top priority. Deliver - Deliver results by inspiring and mobilizing people and teams. Required Leadership Competencies (J&J Regulatory Affairs Competency Model): Applied Technical Knowledge (Expert) Business Acumen (Leading) Decision Making and Prioritization (Expert) External Focus (Leading) Leading and Influencing (Leading) Persuasive Communication (Expert) Required Technical Competencies & Knowledge Regulatory Strategy Good understanding