Manager, Regulatory Affairs

Job Descriptions

• Oversee and manage the entire process of product registration, ensuring compliance with regulatory requirements and timely submissions local and overseas.
• Plan, coordinate, and execute Regulatory Affairs (RA) activities within the designated region, ensuring alignment with company objectives and regulatory standards.
• Manage the full regulatory lifecycle of products, including initial submissions, approvals, variations, renewals, and ongoing maintenance with the national regulatory authorities.
• Conduct feasibility assessments of new products for importation, ensuring alignment with national regulations and market entry strategies.
• Gather, prepare, and review all necessary data for product registration, ensuring that submissions meet the required standards for regulatory acceptance.
• Serve as the primary point of contact with national regulatory authorities, developing and presenting strategies for new product submissions and portfolio maintenance.
• Foster and maintain strong professional relationships with regulatory bodies to ensure smooth communication and negotiation on regulatory matters.
• Stay updated on regulatory changes and trends, providing strategic input on how they may impact current and future product registrations.
• Provide cross-functional support to internal teams, including Business Development, marketing, sales, and R&D, to ensure regulatory compliance is integrated into product development and commercialization processes.
• Plan and execute departmental KPIs, regulatory project trackers, submission dashboards, issue logs, and portfolio monitoring mechanisms to ensure visibility of regulatory progress and risks.
• Participate in regulatory authority inspections, internal audits, supplier audits, principal audits, and support for GDP, GDPMD, ISO 13485 and other applicable quality management systems, according to the company's licensed activities and risk assessments, CAPA, change controls, deviation management, complaints, and recall procedures.
• Responsible for Internal Regulatory Compliance, Regulatory Affairs (MAL, MDA,NOT,Halal, KKLIU, Food, Wholesale License etc, Internal Regulatory Compliance.
• Responsible for the External Audit and compliance which involved the division policies and procedure
• Lead the Global Market Registration Expansion - Vietnam, Thailand, Indonesia, Philippines & Singapore.

Requirements:

• Bachelor's Degree in Pharmacy (preferred), or a degree in Science/Nutrition or a related field.
• At least 10 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.
• Able to work at Bukit Raja Klang 2 (Near Setia Alam).