Regulatory Affairs Manager

Job Responsibilities

• Responsible for local regulatory submissions, developing regulatory strategies, and ensuring compliance with applicable laws and regulations.
• Collaborate with various internal departments and external agencies to achieve regulatory objectives and support business goals.
• Stay up to date with regulatory changes and maintain positive relationships with regulatory authorities and trade associations.
• Develop and execute local regulatory submissions plan in adherence to relevant regulations.
• Contribute to the development of regulatory strategies for new products and changes to existing products, aligning them with business objectives.
• Review, compile, and submit NDAs for drug and medical device products, following local regulations and international formats such as ICH and ACTD.
• Manage the compilation and submission of responses to queries raised during NDA evaluations, coordinating with international functions, and ensuring timely approval.
• Collaborate with commercial teams to address regulatory requirements for new product launches, including activities related to promotional material reviews and alignment with brand guidelines and registered product details.
• Manage compliance of product labels and collaborate with the supply chain to implement regulatory requirements in commercial shipments within Malaysia.
• Ensure regulatory compliance and support license renewals for the existing product portfolio, aligning with business needs.
• Maintain regulatory systems, databases, and connections with local authorities.
• Provide regulatory advice to colleagues within the organization, including regulatory colleagues and other departments.
• Collate information from the region for periodic safety updates reports.
• Stay informed about regulatory changes in the local market and monitor their potential impact on the organization.
• Liaise with internal functions such as Production, R&D, and QA departments to facilitate regulatory operations and ensure alignment.
• Manage product submissions, registrations, and compliance with international regulatory standards by preparing and submitting technical dossiers or files to local regulatory authorities.
• Liaise with international functions, such as Research and Development and Quality Assurance, to ensure timely submission and approval of manufacturing site changes and transfer applications.
• Develop and maintain professional relationships with regulatory authorities and trade associations, aiming to influence positive changes in the regulatory environment.
• Support registrations in new or export markets for commercial development.
• Engage with export parties to establish a list of products for export and manage regulatory requirements.
• Handle queries from potential export parties and overseas health authorities.
• Manage company regulatory affairs activities, including reports, license transfers, and renewals, to ensure compliance with government requirements and company standards.
• Perform any other ad-hoc duties as and when assigned by the Company.

Job Specification

• Bachelor's degree in Pharmacy, Life Sciences, or a related field. Advanced degree preferred.
• Minimum of 10 years of experience in regulatory affairs within the pharmaceutical industry.
• In-depth knowledge of local regulations, ICH guidelines, and international regulatory standards.
• Proven experience in managing regulatory submissions, including NDAs and technical dossiers.
• Strong understanding of drug and medical device regulatory processes and requirements.
• Excellent project management skills with the ability to coordinate multiple stakeholders.
• Strong interpersonal and communication skills to collaborate effectively with internal and external stakeholders.
• Attention to detail and ability to work in a highly regulated and compliance-driven environment.
• Proficient in using regulatory systems and databases.
• Familiarity with safety updates reporting and market intelligence activities.
• Ability to stay updated with regulatory changes and adapt strategies accordingly.
• Fluent in English (written and verbal).
• Regulatory affairs certifications or professional memberships are desirable.