Job Description

Regulatory Affairs Leader, ASPAC - MedTech

Caring for the world, one person at a time, inspires and unites Johnson & Johnson. J&J embraces research and science - bringing innovative ideas, products and services to advance health and well-being. Employees of the Johnson & Johnson Family of Companies work with partners in health care to touch the lives of over a billion people every day, throughout the world.

With $82 billion in sales, Johnson & Johnson is the world\'s most comprehensive and broadly-based manufacturer of health care products, as well as a provider of related services, for the consumer, pharmaceutical, and medical devices markets. The more than 250 Johnson & Johnson operating companies employ approximately 132,000 people in 60 countries throughout the world.

As the Regulatory Affairs Leader for ASPAC - MedTech, you will play a vital role as a member of the Global Regulatory Affairs organization. Based in the Asia Pacific region, you will be at the forefront of leading regulatory affairs activities and driving the long-term growth strategy for the region. Your expertise and influence will extend to Health Authorities through networking and active engagement with local and regional trade associations. Your leadership and guidance will be instrumental in aligning regulatory affairs within the region, fostering integration among countries, and strengthening collaboration with global stakeholders. Additionally, you will provide strategic feedback into product-related activities, ensuring seamless integration throughout product development and the entire lifecycle.

As a pivotal leader in the organization, this position holds overall responsibility for leading and guiding staff across the region, including regional offices and local operating companies. The Regional Head plays a crucial role in ensuring the efficient operation of the region, supporting the needs of operating companies, and facilitating expeditious development, submission, and approval of products within the region. A crucial aspect of this role is fostering understanding and alignment of goals and objectives at global, regional, and local levels. Collaborating closely with global compliance functions, the position ensures a robust and dependable compliance framework at both the regional and local levels, instilling confidence in the organization\'s commitment to compliance and regulatory excellence.

This role holds influence both locally and within Global Regulatory Affairs. Beyond serving as the representative for Regulatory Affairs on the regional management board/team, the position plays a part in shaping key regional governance matters, ranging from business decisions and people management to product prioritization. The individual in this role also assumes a vital position within the GRA leadership team, fostering seamless integration of regional initiatives with global regulatory strategies and processes. Through effective collaboration and strategic vision, this position ensures a collaborative approach to regulatory affairs, enhancing the impact of global strategies on the regional level and vice versa.Qualifications

• Minimum of a bachelor\'s degree (or equivalent) in science/health-related field. Advanced degree preferred.
• Minimum of 15 years of relevant regulated industry experience; 6 years in Regulatory Affairs preferred. Must possess a good understanding of R&D and commercial processes and business needs. Experience in a local operating company and/or regulatory agency is a plus.
• Knowledge of the regulatory environment, guidelines and practice throughout Asia Pacific
• Working knowledge of regulations and guidelines related to devices, combination products, biologics, and advanced technology products development and registration. Breadth of global regulatory affairs experience is a plus.
• Global regulatory experience, with experience in contribution to regulatory and clinical strategies
• Experience in Health Authority interactions. Ability to act as company spokesperson with Health Authorities.
• Experience specifically in the region is desirable, though global experience or experience in regions will be considered.

Experience and key competencies:

• Proven leadership, organizational, and people management skills. Track record of staff development. Able to develop highly motivated and talented people.
• Excellent English verbal and written communication skills, ability to work and thrive in a multi-cultural environment, and ability to work in a multi-discipline (including R&D, market access and commercial) matrixed environment are required.
• Facilitation skills to generate consensus among key customers and local, regional and global partners. Strong influencing skills.
• Delivery of results and experience accomplishing objectives through people
• Ability to influence senior level management
• Demonstrated ability to multi-task, prioritize multiple complex priorities. Forward thinking. Ability to lead crisis situations.
• Demonstration of long-term strategic insight and innovative thinking.
• Knowledge and understanding of the MedTech business, health care environment and regional emerging market social economic dynamics
• Understanding of the global regulatory and health care environment
• Preferably multi-lingual (excellent English required; applicable language(s) of the region is a plus, e.g., Mandarin).

Location:
Based in Singapore, China, or Japan (other regional markets to be considered)

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