Regulatory Affairs Team Leader – Trưởng Nhóm Đăng Ký Thuốc

POSITION OVERVIEW | TỔNG QUAN VỊ TRÍ

We are seeking an experienced Regulatory Affairs Team Leader to lead the Regulatory Affairs team for imported pharmaceutical products in Vietnam. This role is responsible for managing daily regulatory operations, leading the team, ensuring compliance with Ministry of Health (MOH) regulations, and supporting the company's portfolio expansion and business growth.

KEY RESPONSIBILITIES | NHIỆM VỤ CHÍNH

Leadership & Team Management

• Lead, supervise, coach, and develop the Regulatory Affairs team.

• Allocate workload, monitor project progress, and ensure timely completion of regulatory activities.

• Review and approve regulatory dossiers before submission.

• Build a collaborative, accountable, and high-performing team.

Regulatory Affairs Operations

• Oversee preparation, review, and submission of CTD dossiers for imported pharmaceutical products.

• Manage product registrations, renewals, variations, post-approval changes, and deficiency responses.

• Ensure compliance with DAV, MOH regulations, GMP requirements, and applicable pharmaceutical legislation.

• Monitor regulatory changes and implement updates within the organization.

Cross-functional Collaboration

• Coordinate with overseas manufacturers and regulatory authorities.

• Collaborate closely with QA, Import & Export, Supply Chain, Sales, Marketing, and other departments to support product registration and launches.

• Resolve regulatory issues and provide regulatory guidance to internal stakeholders.

Process Improvement

• Improve Regulatory Affairs procedures and enhance operational efficiency.

• Perform other duties assigned by Management.

QUALIFICATIONS &

Yêu cầu công việc

QUALIFICATIONS & EXPERIENCE

Education

• Bachelor's degree or above in Pharmacy.

• Registered Pharmacist certificate is an advantage.

Experience

• Minimum 06 - 08 years of Regulatory Affairs experience in pharmaceutical companies.

• At least 3+ years of leadership role experience.

• Extensive experience in imported pharmaceutical product registration.

• Strong knowledge of CTD, GMP, Vietnamese pharmaceutical regulations, and product lifecycle management.

• Good English communication skills.

PROFESSIONAL COMPETENCIES

• Strong leadership and people management skills.

• Excellent communication and cross-functional collaboration.

• Strong planning, project management, and organizational skills.

• Strategic thinking with strong problem-solving ability.

• High integrity, accountability, and attention to detail.

COMPENSATION & BENEFITS

• Competitive salary based on qualifications and experience.

• Performance bonus and 13th-month salary.

• Social insurance in accordance with Vietnamese Labor Law.

• Other additonal perks to be discussed during interview.

• Professional, dynamic, and long-term career development opportunities.

Quyền lợi

• Thưởng: Competitive salary based on qualifications and experience
• Chăm sóc sức khoẻ: Chế độ BHXH đầy đủ theo quy định của Pháp Luật
• Nghỉ phép có lương: Nghỉ phép năm, lễ tết theo quy định / Annual leave, holidays according to regulations
• Hoạt động nhóm: Annual company trip.
• Khác: Competitive salary package based on experience and qualifications.