Job Description

Exciting role for Pharmacists with RA experience who are interested in working in a pharmaceutical MNC setting and manage regulatory affairs tasks for immunology and specialty care portfolios.

• Regulatory Compliance:

• Monitor and interpret relevant regulations, guidelines, and standards applicable to healthcare products and services.
• Develop and implement regulatory strategies to ensure compliance with local, regional, and international regulatory requirements.
• Conduct regulatory assessments and gap analyses to identify areas for improvement and ensure ongoing compliance.
• Product Registration and Approvals:

• Manage the preparation and submission of regulatory applications for product registrations, licenses, and approvals.
• Liaise with regulatory authorities and agencies to facilitate timely approvals and resolve any regulatory issues or queries.
• Maintain regulatory documentation and records in accordance with regulatory requirements.
• Quality Assurance and Control:

• Collaborate with quality assurance and quality control teams to ensure adherence to regulatory requirements related to product quality, safety, and efficacy.
• Participate in internal and external audits to assess compliance with regulatory standards and identify corrective actions as needed.
• Regulatory Strategy and Planning:

• Develop and execute regulatory strategies aligned with business objectives and market requirements.
• Provide regulatory guidance and support to cross-functional teams involved in product development, manufacturing, and marketing.
• Stay abreast of emerging regulatory trends and developments to anticipate potential impact on their operations and products.
• Risk Management:

• Assess regulatory risks associated with product development, manufacturing, and distribution activities.
• Implement risk mitigation strategies to address potential regulatory challenges and minimize compliance-related issues.

Global pharmaceutical MNC|Attractive salary package

• Bachelor\'s degree in pharmacy. A licensed pharmacist is very much preferred.
• Minimum of 8-10 years of experience in regulatory affairs within the pharmaceutical industry (Niche portfolio).
• In-depth knowledge of Malaysian and international regulatory requirements and guidelines.
• Strong analytical and problem-solving skills.
• Excellent written and verbal communication skills in English and Bahasa Malaysia.
• Detail-oriented with strong organizational and project management skills.
• Ability to work independently and as part of a team.
• Proficiency in Microsoft Office applications.

Our client stands as a prominent ethical pharmaceutical company in Malaysia, this organisation is dedicated to enhancing pharmaceutical drugs and health through its extensive portfolios of ethical drugs. With a strong commitment to innovation and collaboration, the company serves as a trusted partner for Healthcare professionals.

• Opportunity to be part of a dynamic and innovative healthcare company at the forefront of industry advancements.
• Competitive compensation and benefits package.
• Collaborative and inclusive work environment that values diversity and creativity.
• Career growth and development opportunities.

Michael Page