Job Responsibilities:
R&D:
1. Develop and implement strategic plans for the long-term and short-term research and development of proprietary Chinese medicines, setting clear priorities and goals.
2. Establish and refine processes and standards for the research and development of proprietary Chinese medicines, ensuring consistency and adherence to best practices.
3. Oversee the initiation, evaluation, and decision-making of R&D projects, ensuring scientific rigor, feasibility, and innovation.
4. Foster collaborative relationships with universities, research institutions, and medical organizations, spearheading industry-university-research partnerships.
Regulatory Affairs:
1. Develop and implement regulatory strategies to ensure compliance with domestic and international regulatory requirements.
2. Advise cross-functional teams on regulatory requirements and assist with the interpretation and implementation of regulations.
3. Develop and maintain drug registration and compliance records, review and assess product complaints and adverse events to ensure compliance with reporting requirements, as well as maintain awareness of changes in regulatory requirements and industry trends that could impact the organization.
4. Build strong relationships with regulatory authorities and participate in meetings and negotiations as needed.
Qualifications:
1. Master’s degree or higher in pharmacy, pharmaceutical engineering, or related fields.
2. Fluency in both Chinese and English is required.
3. Minimum of 5 years of experience in regulatory affairs in the healthcare, biotech, or pharmaceutical industry and minimum of 5 years of experience in drug R&D.
4. Expert knowledge of regulations, guidelines, and requirements for drug registration.
5. Deep expertise in drug development processes and technologies, with a strong command of modern drug R&D techniques and methodologies.
6. Exceptional leadership, communication, coordination, and project management skills.
7. Ability to work in a fast-paced environment with changing priorities and tight timelines.
8. Ability to lead and work collaboratively with cross-functional teams.
