Phó phòng Đăng ký thuốc (Deputy RA)

Job Description

Job Responsibilities

1.1. Managing and Coordinating Drug Registration Activities

• Assist the Manager in developing the annual drug registration plan.
• Manage, assign tasks, and monitor the progress of drug registration dossiers according to Ministry of Health regulations.
• Guide, review, and approve drug registration dossiers before submission to authorities.
• Update and disseminate relevant legal regulations on drug registration.

1.2. Reviewing and Controlling Drug Registration Dossiers

• Check and assess the quality of drug registration dossiers to ensure compliance.
• Collaborate with related departments (R&D, QA, QC, Production, etc.) to collect and standardize necessary documents.
• Work with foreign partners to prepare dossiers for imported drug registration.

1.3. Liaising with Regulatory Authorities

• Represent the company in working with the Drug Administration of Vietnam (DAV) and other regulatory bodies on drug registration matters.
• Monitor the dossier evaluation process and handle additional requests or adjustments from authorities.

1.4. Supporting Personnel Management and Training

• Assist the Manager in overseeing and training the department's staff.
• Provide guidance and training on drug registration processes, legal regulations, and necessary skills.

1.5. Reporting and Process Improvement

• Prepare periodic reports on drug registration status and present them to the Board of Directors.
• Propose improvements in the drug registration process to enhance efficiency and minimize risks.

Job Requirement

Job Requirements

1.1. Education and Experience

• Bachelor's degree or higher in Pharmacy, Pharmaceutical Chemistry, or related fields.
• At least 5 years of experience in drug registration, with at least 2 years in a managerial role.
• In-depth knowledge of pharmaceutical laws, circulars, and decrees related to drug registration.

1.2. Skills and Competencies

• Leadership skills: Ability to manage teams and delegate tasks effectively.
• Technical expertise: Proficient in drug registration procedures (domestic drugs, imported drugs, vaccines, biologics, etc.).
• Communication skills and regulatory liaison: Experience in working with the Drug Administration of Vietnam (DAV) and related authorities.
• Foreign language skills: Proficiency in English (reading technical documents, communicating with international partners).
• Logical thinking, attention to detail, and accuracy: Ensuring compliance with legal requirements.