Regulatory Affairs

JOB MAIN PURPOSE

The Regulatory Affairs Lead is responsible for leading all regulatory affairs activities in Vietnam across the product lifecycle, including new registrations, post-approval maintenance, renewals, labeling updates, site transfers, and compliance activities.

The role serves as the primary liaison with local health authorities and relevant external stakeholders, ensuring timely approvals, regulatory compliance, business continuity, and successful execution of regulatory strategies. The incumbent also provides regulatory leadership to support commercial objectives, product supply continuity, and organizational growth.

YOUR ROLE & RESPONSIBILITIES

Regulatory Strategy & Product Lifecycle Management

• Develop and execute regulatory strategies to support product registrations, approvals, renewals, variations, and lifecycle management activities.
• Provide regulatory expertise on product approvals, risk assessments, critical issue resolution, and compliance requirements.
• Ensure timely registration of new products, indications, presentations, and product changes.
• Manage regulatory submissions and interactions with local health authorities to secure optimal approval outcomes.

Regulatory Leadership & Team Management

• Lead and manage the local Regulatory Affairs function, including talent development, succession planning, coaching, and performance management.
• Ensure effective implementation and maintenance of regulatory processes, systems, and quality standards.
• Support capability development within the regulatory team through training and knowledge sharing.

Regulatory Compliance & Quality Management

• Ensure compliance with applicable regulatory requirements and internal quality standards throughout the product lifecycle.
• Maintain regulatory documentation, submission tracking systems, and archiving processes.
• Support internal and external audits and ensure readiness for regulatory inspections.
• Collaborate with Quality and Supply teams to manage product complaints, recalls, GMP-related activities, and compliance requirements.

External Stakeholder Management

• Build and maintain strong relationships with local health authorities, industry associations, and external stakeholders.
• Represent the organization in regulatory discussions and industry forums.
• Monitor changes in the regulatory environment and proactively assess their impact on the business.

Cross-Functional Collaboration

• Partner closely with Commercial, Medical Affairs, Market Access, Quality, Supply Chain, and regional stakeholders to support business objectives.
• Provide regulatory guidance for promotional materials, product launches, business initiatives, and strategic projects.
• Contribute regulatory expertise to commercial planning and issue management activities.

Regulatory Intelligence & Process Improvement

• Monitor emerging regulations, industry trends, and regulatory developments.
• Translate regulatory changes into actionable business recommendations and opportunities.
• Drive continuous improvement of local regulatory processes, SOPs, and operational effectiveness.

YOUR KEY SKILLS & QUALIFICATIONS

Education

• Bachelor's Degree in Pharmacy.
• Advanced qualifications in Regulatory Affairs, Pharmaceutical Sciences, or related disciplines are advantageous.

Experience

• Prefer candidate already have solid Regulatory Affairs experience within the pharmaceutical industry.
• Proven experience managing regulatory submissions, product registrations, renewals, and lifecycle management activities.
• Demonstrated experience interacting and negotiating with local health authorities.
• Experience leading teams and managing complex regulatory projects is preferred.

Technical Knowledge

• Strong knowledge of local pharmaceutical regulations and registration requirements.

• Good understanding of international regulatory frameworks and standards, including:

• ICH Guidelines

• ASEAN Harmonization

• GMP Requirements

• Good Storage Practice (GSP)

• Good Distribution Practice (GDP)

• Knowledge of product lifecycle management and regulatory compliance processes.

Skills & Competencies

• Strong leadership and people management skills.
• Excellent stakeholder management and influencing capabilities.
• Strong communication and negotiation skills.
• Strategic thinking and business acumen.
• Strong analytical and problem-solving capabilities.
• Ability to manage multiple priorities and work effectively under pressure.
• Excellent organizational and project management skills.
• Fluent English communication, both written and verbal.
• Collaborative, proactive, and solution-oriented mindset.

Preferred Attributes

• Experience working within multinational pharmaceutical organizations.
• Exposure to regional or global regulatory environments.
• Experience supporting business growth initiatives, product launches, and regulatory transformation projects.

 

 

 

Application Period:

13 Oct - 30 Oct 2026

Reference Code:

887955  

 

Division:

Pharmaceuticals  

Location:

Ho Chi Minh/ Hanoi

 

Functional Area:

Regulatory Affairs  

Position Grade:

 

 

Employment Type:

Regular 

Work Time:

Standard

 

 

 

Contact Us

 

Email: 

 

 

tam.nguyen2.ext@bayer.com