Our client, an established Traditional Chinese Medicine Company , is establishing Singapore as its headquarters outside of China. We are inviting invitations for :
(Senior) Regulatory Affairs and Research Executive
Job Responsibilities:
1. Act as the regulatory liaison between the company and regulatory bodies (e.g., Health Sciences Authority) to support/manage product applications, registrations, and certifications for new market entry; maintain licenses (e.g. Marketing Authorizations) in compliance with local regulations, ensuring corporate regulatory processes, SOP’s and systems are in place.
2. Prepare and collate technical data, product information, and ensure all documentation related to registration, production, and promotional materials is compliant with regulatory requirements in Singapore.
3. Responsible for developing and supporting relationships with key external agencies; facilitate meetings and participate in negotiations with regulatory authority as necessary.
4. Facilitate the drug export from China to Singapore, in compliance with exporting policies.
5. Assist the screening and research of proprietary Chinese medicine formulations; provide consultative and intelligence support to internal stakeholders.
Qualifications:
1. Master's degree or above in Pharmacy, Pharmaceutical Science, Pharmaceutical Engineering, or a related field.
2. Bilingual, both Chinese and English. (spoken and written).
3. A minimum of three years of working experience is required. At least two years of drug registration experience. Preferably a registered pharmacist with the Singapore Pharmacy Council, would be advantageous. Proprietary Chinese medicines is preferred.
4. Proven ability to manage regulatory issues.
5. Knowledge of regulatory environment and how this impacts regulatory strategy and implementation.
6. Knowledge of drug development practice, rules, regulations and guidelines.
