Manager, Regulatory Affairs

Ansell-2; Cyberjaya; On-site; MYR 180,000 - 300,000; Full time

Job summary

Ansell Limited is seeking a Manager, Regulatory Affairs to lead SEA regulatory registrations and compliance for Medical and PPE products. You will collaborate with APAC leadership and cross-functional teams to ensure market access across SEA markets.

Responsibilities include managing registrations, labeling oversight, and regulatory training, while guiding regulatory strategy and maintaining relationships with authorities and internal stakeholders.

Qualifications

• Bachelor of Science in Regulatory, Scientific or Technical Discipline or equivalent.
• Minimum 7 years in Regulatory Affairs or related discipline in medical devices / PPE products.
• Working knowledge of SEA medical device and PPE regulatory requirements.
• Demonstrates Ansell values and leads by example.
• Provides leadership and direction to regulatory team members.
• Clear, professional communication with internal and external stakeholders.
• Works independently with sound judgement and practical solutions.
• Builds effective working relationships and contributes to team performance.
• Manages competing priorities and meets deadlines under pressure.

Responsibilities

• Lead SEA regulatory registrations, certificates and dossiers per Medical, PPE and related regulatory requirements.
• Lead or contribute to regional initiatives requiring Regulatory Affairs expertise, including support to APAC RA Lead.
• Act as regulatory contact with authorities, stakeholders and partners to support SEA compliance and decision-making.
• Plan and coordinate day-to-day regulatory activities, resolving RA issues for SEA countries.
• Provide regulatory input for new product development and existing Medical/PPE portfolios for SEA access.
• Review and approve product claims, labelling, artwork and regulatory approvals.
• Provide regulatory/technical guidance to stakeholders and deliver training on SEA regulatory requirements.
• Manage and develop direct reports in line with Ansell policies.
• Perform other regulatory duties as required.

Education

Bachelor of Science in Regulatory, Scientific or Technical Discipline or equivalent

Job description

Job Description - Manager, Regulatory Affairs (30012325)

Job Description

Manager, Regulatory Affairs - ( 30012325 )

Description

Ansell is a leading global provider of protection solutions. Our company designs, develops and manufactures a wide range of protection solutions that meet the ever-changing needs and demands of our markets and industries. Protection is our primary concern as millions of people around the world depend on Ansell in their professional and personal lives.
Our vision is to create a world where people can enjoy optimal protection against the risk they are exposed to. Whether at work or during their leisure time, people require the right protection for the right application. After all, what better guarantee is there than increased safety, security and productivity than through adequate protection.

GENERAL SUMMARY OF POSITION

The Manager, Certification & Regulatory Compliance SEA is responsible for supporting market access and ongoing regulatory compliance for Ansell Medical and PPE products across SEA markets. The role provides regulatory leadership, stakeholder engagement and practical guidance to support product registrations, portfolio maintenance and business priorities. The position works closely with APAC regional leadership, functional, manufacturing and commercial teams to ensure regulatory requirements are understood, implemented and maintained effectively.

RESPONSIBILITIES

• 1. Regulatory Compliance, Registration & Documentation Lead and maintain SEA regulatory registrations, certificates and registration dossiers, ensuring compliance with applicable Medical, PPE and related regulatory requirements.
• 2. Cross-Functional Leadership & Regional Support Serve as a lead or key contributor on SBU, functional, manufacturing and regional initiatives requiring Regulatory Affairs expertise, including assigned support to the APAC RA Lead.
• 3. Regulatory Representation & Stakeholder Engagement Act as a key regulatory contact with relevant authorities, internal stakeholders and external partners to support SEA market compliance and regulatory decision-making.
• 4. Regulatory Operations & Issue Resolution Lead, plan and coordinate day-to-day regulatory activities, resolving administrative, process and compliance-related RA issues for SEA countries as required.
• 5. Strategic Regulatory Guidance & Product Portfolio Support Provide regulatory input for new product development and existing Medical and PPE product portfolios to support compliance and market access in SEA.
• 6. Regulatory Approval, Claims & Labelling Oversight Review and approve product claims, labelling copy, artwork, change inputs and related regulatory approvals to ensure alignment with applicable regulations and international standards.
• 7. Regulatory Technical Support & Training Provide clear, timely regulatory and technical guidance to internal and external stakeholders and deliver training on relevant SEA Medical and PPE regulatory requirements as appropriate.
• 8. Team Leadership & Development Manage and support the professional development, performance and engagement of direct reports in line with Ansell policies and procedures.
• 9. Other Regulatory Duties Perform additional regulatory responsibilities as required to support ongoing business and compliance needs.

REQUIREMENTS

• Bachelor of Science in Regulatory, Scientific or Technical Discipline or equivalent combination of training and experience. M
• Minimum 7 years in Regulatory Affairs or related discipline in medical devices / PPE products, demonstrated leadership and rapport in working with local Regulatory Bodies.
• Working knowledge of Ansell products preferred.
• Working knowledge of SEA medical device and PPE product regulatory requirements
• Demonstrates Ansell values and leads by example.
• Provides clear leadership, direction and support to regulatory team members.
• Communicates clearly and professionally with internal and external stakeholders.
• Works independently, applies sound judgement and proposes practical solutions.
• Builds effective working relationships and contributes positively to team performance.
• Manages competing priorities, meets deadlines and remains effective under pressure.

Work Locations

Work Locations: MY Selangor Cyberjaya Prima 6 Prima Avenue Block 3512 Prima 6 Prima Avenue, Block 3512 Jalan Teknokrat 6 Cyberjaya 63000