Regulatory Affairs Manager

1.1. Managing & Coordinating Registration Activities

• Build and implement annual registration plans for pharmaceuticals.
• Manage, assign tasks, and supervise the preparation and submission of registration dossiers for drugs.
• Review, evaluate, and approve dossiers before submitting to the Drug Administration of Vietnam (DAV) and other authorities.
• Update and communicate regulatory changes related to pharmaceuticals, variations, renewals, and licensing processes.

1.2. Reviewing & Controlling Drug Dossiers

• Assess dossier quality to ensure full compliance with MOH regulations and guidelines for drugs.
• Work closely with foreign manufacturers/partners to obtain, standardize, and finalize technical documents (CTD format, GMP, CPP, LOA, etc.).
• Coordinate with internal departments (QA, QC, PV, Warehouse, Supply Chain…) to ensure documentation meets regulatory requirements.
• Review documents related to product quality, stability data, manufacturing processes, and foreign regulatory certificates.

1.3. Acting as a Regulatory Liaison

• Represent the company in working with DAV, local health authorities, and inspection bodies on drug matters.
• Track dossier evaluation progress, respond to official letters, and manage additional requests from authorities.
• Work with foreign partners to resolve regulatory issues, update technical documentation, and ensure timely approval.

1.4. Personnel Management & Training

• Manage and supervise the RA team, including performance evaluation and daily task coordination.
• Train staff on regulations for drug registration, documentation standards, and communication with foreign partners.
• Develop internal procedures to enhance compliance and dossier preparation efficiency.

1.5. Reporting & Compliance Improvement

• Prepare regular reports on registration status for products and present to the Board of Directors.
• Propose improvements to optimize the drug registration process and minimize regulatory risks.
• Support compliance activities related to drugs, such as post-approval changes and license renewals.

Yêu cầu ứng viên

• Bachelor’s Degree in Pharmacy.
• Minimum 7 years of experience in Regulatory Affairs, with at least 3 years of managerial experience in pharmaceutical registration in Vietnam preferred.
• Strong knowledge of EU-GMP, MOH regulations, DAV guidelines, pharmaceutical variations, and renewal procedures.
• Advanced English proficiency, especially strong presentation and communication skills.
• Proven experience working directly with foreign manufacturers, principals, or licensors.
• Strong leadership, communication, negotiation, and problem-solving skills.
• High sense of responsibility, strong attention to detail, and ability to work effectively under pressure.

Quyền lợi được hưởng

• Competitive salary and benefits.
• Full insurance package (Social, Health, Unemployment Insurance).
• Lunch allowance; company-provided working devices.
• Teambuilding activities, annual company trip, birthday gifts, and other company benefits.
• Professional environment with opportunities to work directly with international partners.
• Clear career path