Drug Registration Manager/Senior Manager
Salary range:
To be negotiated
Experience requirements:
5-10 years
Minimum education level:
Master's degree
Nature of work:
Full-time
Number of positions available:
2
Job Responsibilities:
1. Responsible for the strategic design and drafting of implementation plans for registration projects of imported pharmaceuticals and medical device products;
2. Participate in negotiations for overseas projects, providing professional advice and recommendations from the perspectives of product registration compliance and feasibility; also participate in discussions with foreign parties, receive and confirm registration documents.
3. Complete the registration and filing of imported products, including document preparation, document submission, follow-up and communication after acceptance, sample registration testing, and on-site inspection of the development process;
4. Track, collect, and organize product registration regulations, analyze their potential impact on projects or enterprises, and make corresponding adjustments to the registration plan or propose solutions.
5. Responsible for the coordination and management of externally commissioned registration projects;
6. Complete other relevant tasks assigned by the supervisor.
Job Qualifications:
1. Master’s degree or higher in a pharmacy- or medicine-related field; preference given to graduates of the Japanese-language pharmacy program at a pharmacy university.
2. More than 5 years of experience in pharmaceutical registration submissions; preference given to candidates with experience working at foreign-owned pharmaceutical companies or leading a registration team.
3. Good foreign language skills (English Level 6).
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