Job Description

You are responsible to lead the Regulatory Affairs team of seasoned professionals to achieve effective registration, and ensure regulatory requirements related to distribution, importation, and sale of products, where applicable, are met. This role reports directly into the Country Head and is responsible for Malaysia market ONLY.

• Ensure prompt timelines of the RA Teams in Malaysia (only) for Registration Projects are met in accordance with stakeholders\' objectives and planned product launches.
• Review and coach Regulatory Team members\' daily performances, monitor reporting timelines for Pharmacovigilance, and lead the audits related to Regulatory and Pharmacovigilance for the Company.
• Review and negotiate RA-related agreements, revise and oversee process improvements SOPs for Malaysia.
• Review Health Authority regulations and disseminate within the organization to ensure compliance to regulatory requirements, related to Distribution, Safety, Sale, Marketing and Supply of Pharmaceuticals where applicable.
• Drive and ensure team uphold Company\'s core values when carrying out day-to-day responsibilities and interactions

Be at the forefront of ensuring patients\' access to safe and effective drugs|Be a member of the country leadership team with a global Pharma company

• Master\'s or Bachelor\'s Degree in Pharmacy, Science, or related discipline
• Experiences in leadership, regulatory and pharma & medical device registration are highly essential.
• Understanding QA, Pharmacovigilance, Licensing and Certification for Company are added advantages.
• Able to understand changing dynamics of Pharmaceutical industry
• Proficient and adept at MS Office, Quest3+, Medcast, Medcast 2.0
• Digital & Technology Savvy

My client is a world-leading Biopharma company with over 20 brands catering to over 30 disease areas. Its focused therapeutic areas are Oncology, Rare Diseases, Vaccines, Respiratory, Diabetes and Cardiovascular.

• Work in an international, receptive and transparent corporate culture
• Join the team to make decisions to help improve people\'s lives over time
• Be rewarded with excellent, fair opportunities to grow personally and professionally

Michael Page