Regulatory Affairs Manager

SUN PHARMA; Kuala Lumpur; On-site; MYR 180,000 - 240,000; Full time

Job summary

SUN PHARMA in Malaysia is seeking a Regulatory Affairs Manager to lead regulatory strategies and registrations for Malaysia and Singapore, ensuring lifecycle compliance and timely approvals.

The role focuses on serving as regulatory focal point, coordinating with local and regional teams, managing submissions through QUEST3+ and PRISM, and guiding junior staff. Candidates should have 5–8 years of experience in pharma regulatory affairs and a bachelor’s degree in a related field.

Qualifications

• Bachelor’s degree in Pharmacy or related life sciences.
• Minimum 5–8 years of Regulatory Affairs experience in pharmaceutical industry.
• Experience handling submissions in Malaysia and Singapore.
• Working knowledge of QUEST3+ and PRISM.
• Experience with ASEAN CTD dossiers and regulatory authorities.

Responsibilities

• Prepare, review, and submit regulatory applications including new registrations, variations, and renewals.
• Drive timely approvals by managing submission timelines and regulatory risks.
• Develop and implement regulatory strategies to support product launches.
• Act as liaison with NPRA Malaysia and HSA Singapore.
• Maintain regulatory databases, records, licenses and documentation.
• Provide coaching to junior regulatory staff.

Skills

Regulatory affairs

Stakeholder management

Project management

Leadership

Attention to detail

Education

Bachelor's Degree in Pharmacy

Tools

QUEST3+

PRISM

Job description

Position Summary

The Regulatory Affairs Manager is responsible for executing regulatory strategies and activities to obtain and maintain product registrations in Malaysia and Singapore. The role ensures regulatory compliance throughout the product lifecycle while supporting business growth through timely approvals, effective regulatory planning, and proactive stakeholder management.

The incumbent will serve as the regulatory focal point for assigned product portfolios and collaborate closely with local, regional, and global stakeholders to achieve regulatory objectives.

Key Responsibilities

1. Regulatory Submission Management

• Responsible to prepare, review, and submission of regulatory applications, including:


• New Product Registrations


• Variations


• Renewals


• Responses to Regulatory Queries


• Other product Lifecycle Management Activities


• Ensure all submissions meet regulatory requirements and internal quality standards.


• Drive timely approvals by proactively managing submission timelines and regulatory risks.

2. Regulatory Strategy & Compliance

• Develop and implement regulatory strategies to support product launches and portfolio growth.


• Interpret and provide guidance on evolving regulatory requirements and assess their business impact.


• Ensure compliance with applicable regulations, guidelines, and company policies.

3. Authority & Stakeholder Management

• Act as the primary liaison with regulatory authorities, including NPRA Malaysia and HSA Singapore.


• Build effective working relationships with internal stakeholders, principals, manufacturers, and regional regulatory teams.


• Coordinate responses to agency requests and deficiency letters within established timelines.

4. Submission Systems & Database Management

• Manage submissions through:


• QUEST3+ (Malaysia)


• PRISM (Singapore)


• Maintain accurate regulatory databases, records, licenses, and product registration documentation.

5. Project & Portfolio Management

• Manage multiple projects simultaneously while ensuring prioritization of critical business needs.


• Identify potential regulatory risks and implement mitigation plans.


• Monitor regulatory milestones and provide management with status updates and recommendations.

6. Team Development

• Provide coaching, guidance, and technical support to junior regulatory staff and trainees.


• Promote a culture of accountability, quality, and continuous improvement within the team.

Education & Professional Qualifications

• Bachelor's Degree in Pharmacy, Pharmaceutical Sciences, Life Sciences, Biotechnology, Chemistry, or related discipline.

Experience

• Minimum 5-8 years of Regulatory Affairs experience within the pharmaceutical industry.


• Demonstrated experience handling pharmaceutical submissions in both Malaysia and Singapore.


• Working knowledge of QUEST3+ and PRISM.


• Experience in product registrations, variations, renewals, deficiency responses, and regulatory compliance.


• Experience working with ASEAN CTD dossiers and regulatory authorities.

Competencies & Leadership Attributes

• Leadership & Professional Maturity


• Resilience & Adaptability


• Strategic Thinking


• Resourcefulness & Problem-Solving


• Attention to Detail


• Prioritization & Execution


• Communication & Influencing Skills