Job Description

Are you passionate about regulatory affairs and driven to make an impact in the pharmaceutical industry? This Regulatory Affairs Associate Manager will collaborate closely with the Regulatory Affairs Manager and key stakeholders across Malaysia to drive successful delivery of the business objectives. Your expertise will be crucial in obtaining timely approvals for new products, variations and renewals while ensuring strict adherence to regulatory compliance.

Regulatory Affairs

• Familiar with regulations and guidelines for cosmetics, foods, medical devices, health supplements and herbal/ traditional medicines in Malaysia and Brunei.
• Develop and implement effective regulatory strategies for new product introductions and modifications, ensuring alignment with business objectives.
• Oversee the life-cycle of the existing product portfolio, ensuring regulatory compliance and timely license renewals.
• Prepare and submit technical dossiers (ICH) or technical files to regulatory authorities, ensuring product submissions, registrations, and compliance with international regulatory standards.

Pharmacovigilance

• Ensure timely submission of Adverse Drug Reactions (ADRs) and Adverse Events (AEs) reporting for Malaysia and Brunei, in accordance with local regulatory requirements.
• Evaluate safety data and oversee the preparation of pharmacovigilance reports.

Quality Assurance

• Manage local complaints and recalls processes with support from Group QA and relevant distributors.

One of the largest company with a strong track record in the industry|Highly collaborative and supportive work culture

• Study background: Bachelor\'s degree or professional qualification, preferably with major in Life Science, Pharmacy, Biotechnology or a related technical field
• An established candidate with a minimum of 5 year\'s experience in the Pharmaceutical
• Experience in Regulatory Affairs with strong track records, product registrations and life cycle management. Quality assurance and Pharmacovigilance experience would be an advantage
• Outstanding strategic planning with the ability to develop actionable solutions and recommend strategies
• Exceptional effective interpersonal relationship & communication skills with both internal and external stakeholders
• Have fluent oral and written communication skills in English

Our client is a leading international pharmaceutical company that prides itself on innovation and being at the forefront in various therapeutic areas in more than 20 countries. This company is committed to increasing the quality standard of the market-leading brands that would be trusted to improve people\'s health. The company offers ample opportunities for career advancement and continuous learning through exposure to diverse job scopes.

• Opportunity to build rapport and closely work with various internal and external stakeholders in the healthcare industry
• Highly collaborative and supportive work culture
• Great remuneration package

Michael Page