Job Description

As the Regulatory Affairs Manager, you will be the main person to shape the regulatory landscape within the company and will be expected to develop and drive regulatory strategies to accelerate the products pipeline, manage the life cycle process from submissions, approvals, variation and renewal in accordance with the national regulatory authorities. You will be working closely with the regional RA team, R&D, Production and QA departments.

• Optimise regulatory strategies for new products and changes to existing products, aligned with business objectives
• Manage existing product portfolio life cycle to ensure regulatory compliance and license renewals
• Cross-functional cooperation with R&D, Production, QA departments and external national health authorities
• Manage compilation and submission of responses to queries raised during the evaluation process of NDAs through coordination with relevant parties
• Product submissions, registration and compliance to international regulatory standards by preparation and submission of technical dossiers (ICH) or technical files to regulatory authorities in the country
• Up-to-date and subject matter expert on all regulatory requirements (local, ASEAN, ICH, WHO), market insights
• Assists in Compliance, QA or pharmacovigilance activities wherever necessary

Distinct opportunity to be involved in the growth and evolution of the company|Highly independent working environment with vast opportunities for growth

• 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 years of experience in the Pharmaceutical / Medical Device industry
• Experience in Regulatory Affairs with strong track records, product registrations and life cycle management. Quality assurance 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 an international pharmaceutical company, focusing on innovation-driven specialty care medicine, with a vision to offering medical solutions to overcome the unmet needs for healthcare. The organisation capitalises on its strengths in its global channel resources, strong reputation, distinctive product systems and high quality products over the two decades.

• Distinct opportunity to build and be involved in the growth and evolution of the company
• Promising opportunity to advance in an international company
• Comprehensive remuneration package designed to enhance financial well-being and health

Michael Page