Associate Regulatory Affairs Manager/Regulatory Affairs Manager
- Department: Regulatory Affairs
- Reports To: Vice President, Head of Regulatory Affairs &Quality Assurance
- Location: Singapore
This position is to manage the RA department in terms of obtaining & maintaining registration licenses for the global market, meanwhile providing necessary support in quality assurance matters.
- Prepares registration dossiers for submission to authorities in international countries
- Technical expert in all regulatory affairs related matters of the country
- Coordinates with partners and regulatory consultants abroad to support overseas registration
- Work closely with Head of Regulatory Affairs to develop regulatory strategy for different regions in line with company needs.
- Liaises with health authorities on regulatory matters
- Prepares the response or arguments for queries from the Authority within strict deadline
- Maintains all related product lifecycle management activities and following up on product approval commitments
- Prepare regional registration dossiers (eg. International Common Technical Document (ICTD) and ASEAN Common Technical Document (ACTD)
- Perform regulatory feasibility for new country submissions
- Prepares IND for USFDA submission for product under development stage (Phase II,III)
- Provide regulatory inputs in clinical trials and ethics committee submission
- Coordinate with the appropriate parties for the submission
- Assist in GDP and relevant quality assurance matters
- Mentor and guide new RA staff
- Perform other additional related duties or assignments from the management
- Involve in local industry association meetings
- Perform registration dossier preparation and submission and follow-up until approval
- Ensure 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 5-7 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/pharmaceutical in Europe, North America, Middle East, African countries, 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 firstname.lastname@example.org
- Cover letter
- Expectations: Salary
We regret that only shortlisted candidates will be notified.