Regulatory Affairs Manager

Rxilient Health Pte. Ltd.; Petaling Jaya; On-site; MYR 180,000 - 240,000; Full time

Job summary

Rxilient Health Pte. Ltd. seeks a senior Regulatory Affairs professional to lead local submissions and develop regulatory strategies for Malaysia. You will ensure compliance with local laws, coordinate with internal teams and regulators, and drive NDA submissions for drugs and medical devices.

You will stay current with regulatory changes, manage label compliance and renewals, and build positive relationships with authorities to support product launches and market access.

Qualifications

• Bachelor's degree in Pharmacy, Life Sciences, or related field; advanced degree preferred.
• Minimum of 10 years of regulatory affairs experience in 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 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.

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.

Skills

Regulatory strategy

Regulatory submissions

Project management

Stakeholder collaboration

Attention to detail

English proficiency

Education

Bachelor's degree in Pharmacy/Life Sciences

Advanced degree preferred

Tools

Regulatory databases

Regulatory systems

Job description

• 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.