Job Description:
- Formulate and execute strategic plans with defined priorities and objectives for both short-term and long-term development of proprietary Chinese medicines.
- Establish and continuously refine processes and standards for the R&D of proprietary medicines to ensure consistency and adherence to best practices.
- Oversee the initiation, evaluation, and decision-making processes for R&D projects, ensuring scientific rigor, feasibility, and innovation.
- Develop and implement regulatory strategies to ensure compliance with both domestic and international regulatory requirements.
- Provide guidance to cross-functional teams on regulatory requirements and support the interpretation and application of regulations.
- Manage the development and maintenance of drug registration, compliance records, product complaints, and adverse event reports to meet reporting requirements.
- Monitor changes in regulatory requirements and industry trends to assess their impact on the organization.
- Build and maintain strong relationships with regulatory authorities, participating in meetings and negotiations as necessary.
- Advise and ensure full compliance from cross-functional teams.
- Stay updated on changes and updates in quality procedures and processes, and enforce these changes as required.
Job Requirements:
- At least a Master’s Degree in Pharmacy, Pharmaceutical Engineering, or a related field.
- Fluency in both Chinese (to communicate with Chinese Speaking authorities) and English.
- Minimum of 10 years of senior management experience, including at least 5 years in regulatory affairs and 5 years in drug R&D within the healthcare, biotech, or pharmaceutical industry.
- Expertise in regulations, guidelines, and requirements for drug registration.
To submit your application, please apply online [email protected] or call +(65) 6226 1472 for private and confidential discussion.
Your interest will be treated with the strictest of confidence. We regret that only shortlisted candidates will be notified or contacted.
RN Care Pte. Ltd
EA License No: 17C8900
