Regulatory Affairs Associate

JOB PURPOSE To assist regulatory staff in the renewal and maintenance of Product Registration Licenses in Malaysia and Brunei via a Third-Party Agent. To assist regulatory staff for Life-Cycle Management of all registered products in Malaysia & Brunei such as PI/PIL Update, Artwork Changes, CMC Changes, Change of Sites, New Indications & Dosage Variations, and all other changes that affect the registered information within Regulatory Authorities in Malaysia & Brunei. To assist regulatory staff with all matters pertaining to the registered products, including archiving and retention of the product files. KEY ACCOUNTABILITIES / RESPONSIBILITIES To protect the company’s reputation and license to operate: 1. Comply with relevant national, regional, and global legal and ethical requirements. 2. Implement regulatory governance principles and internal control frameworks. 3. Model and encourage a right-first-time culture and quality in all activities (patient-centered). 4. Proactively identify gaps in processes and mitigate them adequately or escalate. 5. Continuously develop expertise and regulatory knowledge through training curricula, myLearning, and internal and external seminars, courses, and congresses. 6. Effectively contribute to internal audits and external inspections. 7. Provide support in crisis management and product recall. 8. Foster a culture of transparency and trust by ensuring EHS responsibilities and requirements are clearly defined and communicated to staff (e.g. Policy, risks, incident reporting, emergency preparedness). 9. Ensure accountability for compliance with relevant policies, local laws, regulations, permits, and global EHS standards. 10. Identify and manage significant EHS risks arising from processes by monitoring and reporting EHS performance. 11. Ensure discipline and enforcement mechanisms for intentional EHS breaches and non-compliance. To ensure medicines reach patients in compliance with approved dossiers: 12. Implement and maintain controlled regulatory processes. 13. Evaluate, prioritize, plan, and execute regulatory activities on time and thoroughly. 14. Demonstrate a high-performance attitude by delivering objectives, tracking progress, and implementing course correction as needed. 15. Implement and monitor Key Performance Indicators (KPIs) to measure compliance and performance. 16. Live the spirit of Continuous Improvement and a Learning Organization (“allow mistakes but learn from them”). 17. Apply efficient delivery strategies aligned with company fundamentals. To support business strategy through external stakeholder management: 18. Analyze trends and anticipate the future development of regulatory requirements. 19. Identify opportunities and risks for the company, including the competitive environment. To build effective internal relationships and collaborate with key stakeholders: 20. Establish and enhance relationships with business partners, including Medical, Commercial, Quality, Supply Chain, Market Access, and Government Affairs. 21. Bridge Regulatory and Commercial functions through strategic planning and implementation. 22. Develop flexible and effective regulatory solutions for emerging business issues. To provide a competitive advantage in a fast-changing environment: 23. Keep up-to-date with healthcare environments, political, legislative, and regulatory frameworks, and the pharmaceutical industry, including the competitive landscape. 24. Understand key stakeholders and tasks of the Health Ministry, Regulatory Authorities, and other relevant bodies (e.g. Medical Device Authority). 25. Understand GxP, quality guidelines, and regulations relevant to the pharmaceutical industry. 26. Have a basic understanding of the medical knowledge relevant to the product portfolio. 27. Demonstrate robust knowledge of all fundamental regulatory processes. 28. Understand quality and supply chain principles. To drive growth and access to medicines through innovative regulatory solutions: 29. Demonstrate a solution-driven and 'Thinking-Out-Of-The-Box' attitude in addressing challenges and opportunities. 30. Continuously adapt ways of working and develop new strategies to reflect business needs or changes in the legislative or regulatory environment. REQUIREMENTS 1. Bachelor's degree in Life Sciences, Pharmacy, or a related field. 2. Experience in regulatory affairs, specifically in the pharmaceutical industry. 3. Knowledge of regulatory requirements and processes in Malaysia and Brunei. 4. Strong understanding of GxP and other quality guidelines relevant to pharmaceutical products. 5. Ability to communicate effectively with both internal and external stakeholders. 6. Experience with managing product registrations and lifecycle management. 7. Detail-oriented with strong analytical and problem-solving skills. 8. Strong organizational and time management abilities. 9. Proactive, solution-oriented mindset, with the ability to adapt in a fast-paced environment. 10. Knowledge of relevant local and global laws and regulations impacting regulatory affairs. 11. Fluency in English; proficiency in Bahasa Malaysia or Mandarin is a plus.