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Job Function:
Regulatory Affairs GroupJob Sub Function:
Regulatory AffairsJob Category:
People LeaderAll Job Posting Locations:
Singapore, SingaporeJob Description:
Regulatory Affairs Lead, Singapore
Job Description
The Regulatory Affairs Lead, Singapore is responsible for leading the local Regulatory Affairs team and overseeing regulatory strategy, product registrations, lifecycle management, compliance activities, and health authority engagement for the Singapore market. The role serves as the primary regulatory partner to the business, ensuring regulatory requirements are integrated into commercial and operational plans while maintaining compliance with local regulations, company policies, and global regulatory strategies. This position reports to the Associate Director, Regulatory Affairs, SEA.
Responsibilities
Regulatory Policy Awareness & Intelligence
Monitor and evaluate changes to Singapore regulatory requirements, industry standards, and health authority expectations.
Provide regulatory intelligence and impact assessments to SEA and Global Regulatory Affairs partners.
Support implementation of new regulatory requirements through established Quality Management System processes.
Regulatory Strategy, Product Registration & Lifecycle Management
Lead regulatory submissions for new and existing products, including registrations amendments, renewals, and compliance activities throughout the product lifecycle.
Provide country input into regional and global regulatory strategies, projects, and initiatives.
Collaborate with global and regional stakeholders to support successful regulatory filings and product approvals.
Ensure timely regulatory support for product launches and business priorities.
Health Authority Engagement
Build and maintain constructive relationships with the Singapore Health Sciences Authority (HSA).
Represent Regulatory Affairs in interactions with health authorities, industry associations, inspections, and regulatory discussions.
Provide regulatory guidance and recommendations to internal stakeholders on regulatory risks and opportunities.
Regulatory Compliance & Operational Excellence
Ensure compliance with applicable regulatory requirements, company procedures, and quality system processes.
Establish, maintain, and continuously improve regulatory affairs departmental procedures and work processes.
Oversee regulatory databases, tracking systems, and documentation to ensure accuracy and compliance.
Act as regulatory subject matter expert during internal and external audits and inspections.
Business Partnership & Cross-Functional Collaboration
Partner closely with commercial, quality, supply chain, and other cross-functional teams to support business objectives.
Collaborate with cross-BU Regulatory Affairs teams and actively contribute to regional RA governance forums and meetings.
Support issue resolution and risk mitigation related to regulatory matters impacting business continuity and product supply.
People & Talent Management
Lead and develop the Singapore Regulatory Affairs team.
Provide coaching, performance management, and career development support to direct reports.
Manage departmental resources, budget, workload prioritization, and succession planning.
Foster a culture of collaboration, accountability, continuous improvement, and inclusion.
Qualifications
Required Years of Related Experience
Minimum 8 years of Regulatory Affairs experience within the medical device, pharmaceutical, or healthcare industry.
Demonstrated people leadership and team management and stakeholder management experience preferred.
Required Knowledge, Skills and Abilities
Bachelor's degree in Pharmacy, Life Sciences, or a related discipline.
Strong knowledge of Singapore healthcare product regulatory requirements and processes.
Excellent written and verbal communication skills in English.
Ability to interpret complex regulatory issues and communicate them effectively to diverse stakeholders.
Strong project management and organizational skills with the ability to manage multiple priorities.
Proven ability to build effective relationships and work successfully within cross-functional and matrix environments.
Cultural sensitivity and ability to collaborate across diverse teams and geographies.
Proactive, achievement-oriented mindset with flexibility to adapt to evolving regulatory and business environments.
Preferred Skills
Business Writing, Compliance Risk Management, Developing Others, Fact-Based Decision Making, Inclusive Leadership, Regulatory Strategy, Product Registration, Regulatory Compliance, Health Authority Engagement, Project Management, Stakeholder Management, Talent Development, Strategic Thinking, and Operational Excellence. (Adapted from the internal posting template.)
Required Skills:
Preferred Skills:
Business Writing, Compliance Risk, Developing Others, Fact-Based Decision Making, Inclusive Leadership, Industry Analysis, Innovation, Leadership, Legal Support, Operations Management, Policy Development, Product Licensing, Public Policies, Regulatory Affairs Management, Regulatory Compliance, Regulatory Development, Regulatory Environment, Strategic Thinking, Team ManagementJohnson & Johnson Singapore, Singapore, SGP Office
1 Fusionopolis Way, Singapore, Singapore, Singapore, 138632
