Senior Regulatory Affairs

The Regulatory Affairs will be responsible for managing legal registrations, participating in research and development projects, providing product consulting and training, and ensuring quality management of pharmaceutical products. This role requires strong knowledge of regulatory compliance, research trends, and quality standards.

Key Responsibilities

1. Legal Registration:
   • Prepare, review, and submit product registration documents.
   • Ensure compliance with national and international pharmaceutical regulations.
   • Collaborate with regulatory bodies and partners to complete legal procedures.
   • Maintain and update records of licenses and product registrations.
   • Monitor and ensure timely renewal of licenses.
2. Research & Development (R&D):
   • Participate in projects for developing new products.
   • Stay updated on market trends and scientific research.
3. Product Consulting & Training:
   • Provide professional advice on products.
   • Support training for sales staff and customers.
   • Address technical inquiries from customers and the sales team.
4. Quality Management:
   • Verify compliance with GMP and FDA standards.
   • Collaborate with production and quality control departments.
   • Monitor products post-launch.

Job Requirements

• Bachelor’s degree in Pharmacy or a related field.
• At least 3 years of experience in drug registration (Regulatory Affairs).
• Familiarity with legal regulations regarding drug registration, GMP, GSP, GDP standards.
• Experience working with regulatory agencies such as the Drug Administration Bureau, Ministry of Health is advantageous.
• Strong teamwork, problem-solving, communication, and time management skills.
• Ability to read and write technical documents in English.

 Key Competencies

• Strong understanding of regulatory compliance and quality standards.
• Ability to participate effectively in R&D projects.
• Excellent communication skills for product consulting and training.
• Strong analytical skills for quality management and problem-solving.
• Ability to work collaboratively with internal departments and external partners.