Regulatory Affairs Executive
- Department: Regulatory Affairs
- Reports To: Regulatory Affairs Manager
- Location: Singapore
This position is to assist the RA department in terms of obtaining & maintaining registration licenses for the global market, meanwhile providing necessary support in quality assurance matters.
- Prepare registration dossiers for submission to regulatory authorities
- Assist in the development of regulatory strategy for different regions in line with company needs
- Coordinate with partners and regulatory consultants abroad to support overseas registration
- Liaise with authorities on regulatory matters
- Maintain product licenses’ life cycle management
- Assist registration dossier preparation and submission and follow-up until approval
- Assist in ensuring compliance to all relevant requirements pertaining to regulatory and quality so as to maintain continuous business activities.
- The ideal candidate should preferably have at least 2 years of regulatory affairs working experience.
- Knowledge in international regulatory guidelines such as ICH, ASEAN, USFDA, EU etc,, regulatory experience with food supplement/herbal medicine in Europe, North America or Asia Pacific would be a plus.
- Good understanding in GMP, GDP and relevant quality management systems will be an added advantage.
Functional / Technical / Core Competencies
- Excellent proficiency in English (both written and spoken). Additional language such as Mandarin is a strong plus to liaise with external CMOs and partners.
- Independent worker and self-starter with an innovative and process driven view on regulatory affairs activities in line with business development.
- Good team player
- Good time management skill
Education and Professional Qualification
- The ideal candidate should at least hold a degree in life sciences
Please send the followings to email@example.com
- Cover letter
- Expectations: Salary
We regret that only shortlisted candidates will be notified.