HEAD OF REGULATORY AFFAIRS

The Head of Regulatory Affairs will lead and oversee all regulatory strategies and activities to ensure the company’s pharmaceutical products comply with applicable laws and regulations in domestic and international markets. This leadership role involves managing submissions, approvals, and maintaining relationships with regulatory authorities to facilitate smooth product registrations and market access.

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Key Responsibilities:

Regulatory Strategy & Compliance

• Develop and implement comprehensive regulatory strategies for product registration, approval, and lifecycle management in multiple markets.

• Ensure compliance with local and international pharmaceutical regulations (e.g., FDA, EMA, WHO, ICH guidelines).

• Monitor changes in regulatory requirements and proactively communicate their impact on the business.

Product Registration & Submissions

• Oversee preparation, review, and submission of dossiers for new product registrations, renewals, variations, and post-approval changes.

• Coordinate timely and successful approvals from health authorities and regulatory agencies.

Team Leadership & Management

• Lead, mentor, and develop a team of regulatory affairs professionals.

• Allocate resources effectively to meet project timelines and business goals.

• Foster a culture of compliance, continuous learning, and professional development.

Cross-Functional Collaboration

• Work closely with R&D, Quality Assurance, Manufacturing, and Marketing teams to ensure regulatory requirements are integrated into product development and commercialization.

• Provide regulatory guidance and risk assessment throughout product lifecycle.

Liaison with Regulatory Authorities

• Establish and maintain effective relationships with regulatory agencies and authorities.

• Represent the company in meetings, inspections, and audits by regulatory bodies.

Documentation & Reporting

• Ensure all regulatory documentation is accurate, complete, and up-to-date.

• Prepare regulatory reports, risk assessments, and compliance statements for internal and external use.

Qualifications:

• Bachelor’s or Master’s degree in Pharmacy, Life Sciences, Chemistry, or related field.

• Minimum 8-10 years’ experience in pharmaceutical regulatory affairs, including at least 3 years in a managerial or leadership role.

• Deep knowledge of regulatory requirements and submission processes in key markets (e.g., Vietnam, ASEAN, US, EU).

• Experience with electronic submission systems (eCTD) and regulatory databases.

• Strong leadership, communication, and negotiation skills.

• Ability to work under pressure and manage multiple projects simultaneously.

Key Skills:

• Regulatory strategy development

• Product registration & dossier management

• Knowledge of international regulatory frameworks (FDA, EMA, WHO, ICH)

• Team leadership and project management

• Risk assessment & mitigation

• Strong interpersonal and stakeholder management skills

Preferred:

• Experience in pharmaceutical product lifecycle management

• Familiarity with GMP, GDP, and other quality standards

• Ability to work independently and as part of a team

• Proficiency in English (written and spoken)