Full Time Regulatory Affairs Manager Jobs, in SUN PHARMA Federal Territory - Maukerja

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