Regulatory Affairs Manager

Humana International Group; Klang City; On-site; MYR 180,000 - 280,000; Full time

Job summary

Humana International Group in Malaysia is seeking a Regulatory Affairs Manager to lead end-to-end product registration and regulatory compliance across local and international markets.

The role manages submissions, variations, renewals, dossier preparation, and stakeholder liaison with regulatory authorities, ensuring timely market access while aligning with GDP, ISO 13485, and other quality frameworks. Minimum 5 years in pharma regulatory affairs required.

Qualifications

• Bachelor's Degree in Pharmacy (preferred) or related field.
• At least 5 years of experience in Regulatory Affairs within pharma.
• Strong knowledge of national and international regulatory guidelines.
• Excellent communication and interpersonal skills.

Responsibilities

• Oversee end-to-end product registration for local and international markets.
• Plan and coordinate Regulatory Affairs activities across designated markets.
• Manage lifecycle of products including registrations, variations, renewals, and post-approval maintenance.
• Prepare and maintain regulatory dossiers and technical documentation.
• Liaise with national regulatory authorities and stakeholders.

Skills

Regulatory Affairs

Stakeholder management

Regulatory strategy

Attention to detail

Education

Bachelor's Degree in Pharmacy

Job description

Name of Role : Regulatory Affairs Manager

Employment Type: Full-time

About the Company

Our client is one of Malaysia's largest integrated healthcare and retail pharmacy groups, operating over 600 pharmacy outlets nationwide. Our client offers comprehensive healthcare ecosystem, encompassing pharmaceutical distribution, manufacturing, digital health, primary care, and healthcare services.

Role Summary

This role will be responsible for managing the end-to-end product registration and regulatory compliance lifecycle across local and international markets which includes regulatory submissions, approvals, variations, renewals, product maintenance, importation feasibility assessments, and market expansion.

Key Responsibilities

• Oversee the end-to-end product registration process for local and international markets, ensuring timely submissions and compliance with applicable regulatory requirements.
• Plan, coordinate, and execute Regulatory Affairs (RA) activities across designated markets, aligning regulatory strategies with business objectives and applicable standards.
• Manage the complete regulatory lifecycle of products, including new registrations, approvals, variations, renewals, post-approval maintenance, and portfolio updates with relevant regulatory authorities.
• Conduct regulatory feasibility assessments for new products and importation opportunities, evaluating registration requirements, market-entry considerations, and potential regulatory risks.
• Prepare, compile, review, and maintain regulatory dossiers, technical documentation, and supporting data to ensure complete, accurate, and compliant submissions.
• Act as the key liaison with national regulatory authorities, developing submission strategies, managing regulatory correspondence, and facilitating discussions and negotiations on product registrations and portfolio maintenance.
• Establish and maintain effective professional relationships with regulatory authorities and external stakeholders to facilitate efficient communication and resolution of regulatory matters.
• Monitor changes in regulatory requirements, guidelines, and industry trends, assessing their potential impact on existing products, new registrations, and business expansion plans.
• Provide regulatory guidance and cross-functional support to Business Development, Marketing, Sales, R&D, Quality, and other internal teams to ensure regulatory requirements are incorporated into product development and commercialization activities.
• Develop and monitor departmental KPIs, regulatory project trackers, submission dashboards, issue logs, and portfolio monitoring tools to provide visibility of regulatory progress, timelines, priorities, and risks.
• Support and participate in regulatory authority inspections, internal audits, supplier audits, and principal audits, ensuring readiness and timely closure of audit findings and corrective actions.
• Support compliance with GDP, GDPMD, ISO 13485, and other applicable quality management systems, including CAPA, change control, deviation management, product complaints, recalls, and other quality and regulatory processes.
• Manage internal regulatory compliance activities covering MAL, MDA, NOT, Halal, KKLIU, food-related registrations, wholesale licences, and other applicable regulatory licences and approvals.
• Oversee external regulatory audits and compliance activities, ensuring adherence to company policies, procedures, applicable legislation, and regulatory requirements.
• Lead global market registration and regulatory expansion initiatives across Vietnam, Thailand, Indonesia, the Philippines, and Singapore, coordinating market-entry requirements, registration strategies, submissions, and regulatory approvals.
• Identify regulatory risks and develop appropriate mitigation strategies to support timely product registrations, maintain compliance, and facilitate business growth across local and international markets.

Requirements

• Bachelor's Degree in Pharmacy (preferred), or a degree in Science/Nutrition or a related field.
• At least 5 years of experience in the pharmaceutical industry, specifically in Regulatory Affairs.
• Proven track record of successful product registrations, regulatory submissions, and lifecycle management in the pharmaceutical or healthcare sector.
• Strong knowledge of national and international regulatory guidelines and standards.
• Excellent communication and interpersonal skills, with the ability to work effectively with regulatory authorities and internal teams.
• High attention to detail, with strong analytical and problem-solving abilities.
• Ability to manage multiple projects simultaneously and prioritize tasks in a fast-paced environment.