We are currently seeking a Head of R&D, QA & RA for a leading pharmaceutical (TCM) company based in Singapore. This pivotal role requires strong collaboration with regulatory authorities and internal teams to ensure full compliance with industry regulations and standards. The successful candidate will lead the company's R&D initiatives, oversee regulatory affairs, and develop strategies to navigate complex regulatory environments. The role is critical in ensuring that all TCM products meet the highest quality standards while driving innovation and growth within the company.
Reporting to: CEO
Location: Singapore
The role:
R&D:
Formulate and execute strategic plans for both short-term and long-term research and development of proprietary Chinese medicines, establishing clear goals and priorities.
Develop and enhance processes and standards for R&D activities, ensuring alignment with best practices and maintaining consistency in the development of proprietary Chinese medicines.
Lead the initiation, evaluation, and selection of R&D projects, ensuring they meet high standards of scientific rigor, feasibility, and innovation, while fostering partnerships with academic institutions, research centers, and medical organizations.
Regulatory Affairs:
Create and implement regulatory strategies that ensure compliance with both domestic and international regulations.
Provide guidance to cross-functional teams on regulatory requirements, helping them understand and apply relevant regulations effectively.
Manage drug registration and compliance documentation, monitor product complaints and adverse events, and stay informed on regulatory changes and industry trends that could affect the organization, while maintaining strong relationships with regulatory authorities and participating in negotiations as necessary.
Quality Assurance:
- Develop and implement an effective Quality Management System
- Stay updated on changes and updates in quality procedures and processes
The experience:
- Master's degree or higher in pharmacy, pharmaceutical engineering, or a related field
- Ideally with 5 years of experience in drug R&D, QA & regulatory affairs and within the healthcare, biotech, or pharmaceutical industry, with deep expertise in drug development processes and technologies
- Knowledge of regulations, guidelines, and requirements for drug registration, coupled with skills in modern drug R&D techniques and methodologies.
- Ideally with leadership, communication, and project management abilities, with the capacity to collaborate effectively with cross-functional teams and excel in a fast-paced, dynamic environment.
How to apply:
Please provide your CV to Shash Prasanan at shashtidaran.prasanan@atomicgroup.sg, in either Microsoft Word document/pdf format.
EA License No. 23S1885
Registration No. R24121011
