Technical Regulatory Associate Manager

Private Advertiser; Petaling Jaya; On-site; MYR 180,000 - 260,000; Full time

Job summary

Private Advertiser is seeking a senior Regulatory Affairs professional to lead regulatory strategy and lifecycle management for products across Malaysia and Brunei. The role focuses on developing submission plans, governing dossiers, and ensuring ongoing compliance with regulatory requirements.

You will collaborate with Marketing, BD, and Quality teams, oversee external consultants, and drive regulatory excellence to support product launches and sustainable portfolio growth.

Qualifications

• Bachelor's degree in Pharmacy or related field.
• Registered Pharmacist (preferred where applicable).
• 8–10 years regulatory affairs experience.
• Experience developing regulatory strategies and leading registrations.
• Experience engaging with authorities and industry groups.
• Strong project and stakeholder management skills.

Responsibilities

• Develop and execute regulatory strategies for new products and lifecycle management.
• Lead product registrations, renewals, variations, and maintenance of authorizations.
• Monitor regulatory developments and communicate opportunities/risks.
• Provide regulatory intelligence to regional/global stakeholders.
• Lead cross-functional regulatory workstreams and manage external consultants.
• Drive continuous improvement of regulatory processes and systems.

Skills

Regulatory strategy

Cross-functional leadership

Project management

Stakeholder management

Communication

Regulatory intelligence

Education

Bachelor's in Pharmacy

Registered Pharmacist

Job description

1. Regulatory Strategy & Portfolio Management

Develop and execute regulatory registration strategies for new products, reformulations, manufacturing changes, technology transfers, and lifecycle management by evaluating regulatory pathways, regulatory risks, business priorities, and market-specific requirements.

Lead regulatory planning activities to support commercialization timelines, portfolio optimization, and long-term business objectives across Malaysia and Brunei.

Provide strategic regulatory recommendations to cross-functional teams to facilitate informed business decisions while ensuring compliance with applicable regulations.

Identify regulatory risks that may impact product launches, business continuity, or portfolio sustainability and develop appropriate mitigation strategies.

Ensure regulatory strategies remain aligned with regional and global regulatory objectives.

2. Product Registration & Lifecycle Management

Lead regulatory activities for product registrations, renewals, variations, notifications, product classifications, and maintenance of marketing authorizations across assigned markets.

Establish regulatory submission plans and priorities to support business needs and ensure timely product launches.

Oversee preparation, review, and submission of regulatory dossiers, ensuring completeness, accuracy, and compliance with regulatory requirements.

Ensure regulatory approvals, licenses, certificates, and product registrations are maintained throughout the product lifecycle to support uninterrupted product supply.

Monitor registration progress and proactively resolve regulatory issues that may impact project timelines.

Monitor, interpret, and assess emerging regulatory developments, legislation, and industry trends across assigned markets.

Evaluate the business impact of regulatory changes and communicate opportunities and risks to internal stakeholders.

Develop regulatory risk assessment and mitigation plans to ensure ongoing compliance while supporting commercial objectives.

Provide regulatory intelligence and strategic advice to regional and global stakeholders to support business planning and innovation initiatives.

4. Regulatory Advocacy & Government Affairs

Build and maintain effective relationships with regulatory authorities, government agencies, industry associations, and key external stakeholders.

Represent the company in regulatory consultations, industry working groups, and professional organizations to strengthen credibility and influence regulatory policy development.

Lead or support regulatory advocacy initiatives that protect existing business, facilitate market access, and enable future innovation.

Coordinate responses to government inquiries, inspections, and regulatory communications.

5. Scientific & Technical Consultation

Serve as the primary regulatory and scientific advisor to Marketing, Business Development, Product Development, Supply Chain, Quality, Legal, and other cross-functional teams.

Provide strategic guidance on product classification, formulation, ingredient compliance, labeling, claims, advertising, packaging, and technical documentation.

Review and approve regulatory aspects of product labels, promotional materials, and technical communications to ensure regulatory compliance.

Support investigation and resolution of complex regulatory, technical, and product-related issues.

6. Cross-functional Leadership & Project Management

Lead regulatory workstreams for cross-functional business initiatives to ensure regulatory requirements are integrated into project planning and execution.

Collaborate closely with Regional and Global Regulatory Affairs teams to align local regulatory strategies with broader business objectives.

Influence project teams and business stakeholders by providing regulatory expertise throughout the product development and commercialization process.

Manage external regulatory consultants and service providers to ensure quality, efficiency, and timely delivery of regulatory activities.

7. Operational Excellence & Continuous Improvement

Drive continuous improvement of regulatory processes, systems, and documentation to enhance operational efficiency and regulatory compliance.

Develop, implement, and maintain regulatory procedures, standards, and best practices.

Ensure regulatory information management systems and databases remain accurate, complete, and current.

Identify opportunities to leverage digital tools and process improvements to strengthen regulatory operations.

Minimum Qualifications

Bachelor's degree in Pharmacy, Pharmaceutical Sciences, Food Science, Chemistry, Biology, Nutrition, or related scientific discipline.

Registered Pharmacist (preferred where applicable).

Minimum 8–10 years of Regulatory Affairs experience within the pharmaceutical, consumer healthcare, Health Supplement and Traditional Medicine. TM and HS product registration experience is preferred.

Demonstrated experience developing regulatory strategies and leading product registrations across multiple product categories.

Experience engaging with regulatory authorities, government agencies, and industry associations.

Strong project management, stakeholder management, and communication capabilities.