Manager, Regulatory Affairs

Ansell; Cyberjaya; Hybrid; MYR 200,000 - 320,000; Full time

Benefits offered by this job

Competitive compensation

Flexible and hybrid work model

Learning & mentorship programs

Career development opportunities

Job summary

Ansell is seeking a Manager, Regulatory Affairs for our Cyberjaya team to lead regulatory registrations, compliance, and portfolio support across SEA. The role partners with APAC leadership, manufacturing and commercial teams to ensure regulatory requirements are understood and maintained.

You will guide registration, labeling, and claims oversight while shaping regulatory strategy for Medical and PPE products.

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, demonstrated leadership and rapport with regulators.
• Working knowledge of SEA medical device and PPE product regulatory requirements.
• Demonstrates Ansell values and leads by example.

Responsibilities

• Lead SEA regulatory registrations, certificates and dossiers to ensure compliance with Medical, PPE regulations.
• Serve as a lead on cross-functional and regional initiatives requiring Regulatory Affairs expertise.
• Act as regulatory contact with authorities, internal stakeholders and external partners for SEA market compliance.
• Lead day-to-day regulatory activities and resolve RA issues for SEA countries.
• Provide regulatory input for new product development and portfolio support for SEA.
• Review and approve product claims, labeling, and regulatory approvals.
• Provide regulatory guidance and training to internal/external stakeholders.
• Manage and develop direct reports in line with Ansell policies.
• Perform additional regulatory duties as required.

Skills

Regulatory affairs

Leadership

Stakeholder engagement

Clear communication

Strategic thinking

Education

Bachelor of Science in Regulatory, Scientific or Technical Discipline

Job description

Why Ansell?

At Ansell, we stay two steps ahead of workplace risk to deliver innovative safety solutions that enhance people's quality of life. As a global leader in protection solutions, we design and develop a wide range of products including gloves, clothing, and other protective gear to keep workers safe and productive across industrial, medical, and consumer applications.

Discover more about our company, our people, and our values by visiting us at Ansell.

Ansell is looking for a Manager, Regulatory Affairs to join our team in Cyberjaya!

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.

What benefits and opportunities do Ansell offer?

• Competitive compensation plan, including a performance based annual incentive.
• Flexible and hybrid work model.
• A culture of belonging and inclusion, collaboration thrives, and everyone feels seen, heard, and empowered—across our global community.
• Ansell University, LinkedIn Learning and Mentorship programs to develop professional and interpersonal skills.
• Opportunities to advance and grow within the company through LinkedIn Learning and Mentorships.

What your role will be?

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.

What you will bring:

• Bachelor of Science in Regulatory, Scientific or Technical Discipline or equivalent combination of training and experience.
• 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.