Monroe Consulting Group Malaysia, an executive recruitment firm is partnering with an international animal health manufacturer to hire a Regulatory Affairs Manager. The Regulatory Affairs Manager is responsible for leading regulatory strategy, product registration, and regulatory compliance for the company's animal health portfolio in Malaysia. This role ensures timely approvals for new products and effective lifecycle management while maintaining compliance with local regulatory requirements. The role serves as the primary liaison with regulatory authorities, including the NPRA, DVS, and MDIA and collaborates closely with regional regulatory teams and cross-functional stakeholders. This opportunity is based in Selangor, Malaysia.
Job Responsibilities:
Regulatory Strategy & Leadership
- Develop and implement regulatory strategies to support product registration, lifecycle management, and market expansion in Malaysia.
- Provide regulatory guidance to internal stakeholders on development, registration pathways, labeling, and promotional claims.
- Align local regulatory strategies with global and regional regulatory plans.
Product Registration & Submissions
- Oversee preparation and submission of regulatory dossiers for new product registrations, variations, renewals, and extensions.
- Ensure submissions comply with the requirements of the National Pharmaceutical Regulatory Agency (NPRA) and other relevant authorities such as DVS and MDIA.
- Manage regulatory timelines to ensure timely product approvals and launches.
Authority Engagement
- Act as the primary company representative for regulatory interactions with the National Pharmaceutical Regulatory Agency.
- Lead responses to regulatory queries, deficiency letters, and requests for additional information.
- Support and manage regulatory inspections or audits when required.
Regulatory Compliance & Lifecycle Management
- Ensure company products maintain compliance with regulatory requirements throughout their lifecycle.
- Oversee product maintenance activities including variations, renewals, label updates, and safety reporting.
- Monitor regulatory policy changes and assess their impact on the company's product portfolio.
Job Requirements:
- Bachelor's degree in Pharmacy, Veterinary Science, Animal Science, Life Sciences, or a related discipline.
- 6-10 years of regulatory affairs experience, preferably within pharmaceutical, veterinary, or animal health industries.
- Prior experience managing regulatory submissions and approvals in Malaysia.
- Strong knowledge of Malaysian pharmaceutical regulatory frameworks.
- Experience managing Common Technical Document (CTD) submissions.
- Strong leadership and stakeholder management skills.
- Strategic thinking and problem-solving capabilities.
