Johnson & Johnson Careers
Associate Director, Regulatory Affairs, SEA
Requisition ID: 00001DF7
The Associate Director, Regulatory Affairs, SEA is responsible for managing the South East Asia (SEA) Regulatory Affairs department for the Medical Devices business, including ensuring compliance with the statutory Regulatory requirements required by internal Johnson & Johnson policy/procedures and external government legislation/guidelines; overseeing the development and execution of a registration strategy for new products and lifecycle maintenance to drive business success; and monitoring, influencing and reacting to local regulatory changes in the SEA region for Johnson & Johnson Medical Device products.
1. Ensure regional regulatory compliance is maintained across all SEA countries, for existing product licenses and new product introductions
2. Develop and execute a registration plan for license renewals and NPIs that maintains compliance and is in line with business priorities.
3. Establish standard operational procedures to achieve efficiency and compliance within the Regulatory Affairs department, including interfacing with other departments to coordinate the development of regulatory procedures and controls.
4. Lead and maximize operational performance and functional support for SEA Regulatory Affairs.
5. Track, monitor and report on progress of regulatory applications.
6. Proactively review, assess, influence and manage implementation of legislative changes within SEA.
7. Maintain awareness of all changes in-country regulatory requirements pertaining to Medical Devices, disinfectants and other regulated medical products, and provide regulatory intelligence to SEA team and Global Regulatory partners.
8. Responsible for providing SEA regional and specific country input into the global regulatory strategy for new products/indications and variations.
9. Represent company in shaping healthcare policy and regulations for medical devices; act as the primary communication point with the local regulatory authority, industry groups, government agencies, healthcare administrators and relevant stakeholders.
10. Manage expenses with budget and act on variances. Plan the allocation of funds and resources in line with Regulatory Affairs and business strategies.
Leadership and Management
11. Manage regulatory resources to best meet regulatory and business demands. Build a strong competent team to support each market.
12. Instill business ethics and compliance with company policies, laws, regulations related to their jobs.
13. Partner with SEA Regulatory Leaders for Consumer and Pharma to drive One J&J SEA cross-sector initiatives and develop a unified Regulatory community.
Please note that there is no relocation assistance provision for this position.
The primary country location of this role is Singapore.
• Minimum bachelor's degree or equivalent in Pharmacy or Life Sciences or health-related discipline.
• Minimum 12 years of relevant industry experience, including at least 10 years of Regulatory Affairs experience within Medical Devices (preferred), Pharma or Consumer.
• Excellent verbal and written communication skills in English required.
• Demonstrated leadership and contribution to product introduction or development strategies.
• Demonstrated ability to handle multiple projects with competing timelines and priorities.
• Must be able to develop and maintain excellent working relationships, work successfully within a team environment and as an individual contributor.
• Cultural sensitivity and ability to work and thrive in a multi-cultural environment, as well as an ability to work in a matrix environment are required
• Proactive team player, able to take charge and follow-through.
• Achievement-oriented with a high degree of flexibility and ability to adapt to a changing regulatory environment.
Johnson & Johnson International (Singapore) Pte Ltd (8438)