Regulatory Affairs Manager (Pharmaceutical)

• Lead and manage the Regulatory Affairs Department, ensuring that all activities comply with legal regulations and the company's requirements.
• Ensure drug registration processes are completed on time and meet all legal requirements.
• Participate in building and maintaining relationships with drug regulatory authorities and related organizations.
• Develop strategies and plans to ensure the drug registration process is efficient and timely.
• Ensure compliance with procedures and quality standards related to drug registration dossiers.
• Provide creative solutions and optimize the registration process to improve efficiency and enhance the company's competitiveness.
• Monitor issues related to drug registration dossiers and other related matters at the Ministry of Health.
• Report work progress accurately and promptly to management, with the ability to respond to issues quickly.

• Bachelor's degree in Pharmacy or a related field.
• Foreign language: Good command of English in all four skills, with preference for candidates who can also communicate in Japanese.
• Experience in drug registration, preferably in pharmaceutical companies or drug regulatory agencies.
• Solid understanding of drug registration processes and regulations set by regulatory authorities.
• Strong leadership and team management skills, with the ability to work independently.
• Excellent communication and persuasion skills to build relationships with stakeholders.
• Knowledge of quality control and legal procedures related to drug registration dossiers.
• High attention to detail, good organizational and time management skills.
• Willing to work under high pressure and achieve assigned goals.

Adecco