Regional Regulatory Affairs Manager
Regional Regulatory Affairs Manager, APAC
- Oversees and execute the Regulatory Affairs, Pharmacovigilance and Quality Assurance functions/activities of the Company
- Responsible for evaluation, compilation & preparation of registration dossiers and preparing registration applications
- Support due diligence pertaining to RA/QA assessment, and regulatory intelligence for specific products
- Liaise with HSA and other regional HAs/business partners on matters pertaining to regulatoryactivities, licenses and permits
- Ensure that the inhouse quality standards and/or specifications are maintained and in accordance with the HSA standard requirement of GMP/GDP
- Business partner to Business Development team in assessment of registration potential for new portfolio/products expansion
- Keep abreast of the latest regulatory requirements and up to date Regulations, Guidelines, Policies, etc. Identifying new updates and changes, share with cross functional teams and stakeholders about impact and mitigation plans, where necessary.
- Oversee and drive registration activity of the Company's products globally.
- Ensure the distribution of the products to our customers are being followed strictly to national rules & regulations
- Attend to both internal and external audits conducted by internal/external audits certification body for GDPMDS and GDP for Medical/Therapeutic Products and medical devices, where needed
- Ensure incoming PV reports are collected, documented, and archived for accessibility at a single point, reporting ADRs/AEs cases to HAs accordingly, communicate internally and externally with relevant stakeholders/partners
- Liaise with manufacturer and clients on product complaints and any other QA issues, where necessary
- Handle ad-hoc projects (RA PV QA related projects) as and when needed
- A bachelor's degree in pharmacy and must be a registered Pharmacist in Singapore
- Minimum 5 years of experience in Regulatory Affairs
- Proficient in both oral and written English, mandarin is the additional advantage
- Excellent communication skills and leadership qualities
- Able to work independently as well as in a team
- Able to work under pressure
If you meet the essential requirements for this position, please send your latest CV through the link provided, or call Vanessa Tan at +65 6871 4700 for further information.
Only shortlisted candidates will be notified via email.
Registration no: R1873695
EA Licence no: 16S8216
Real, a trading division of SThree Pte Limited (Registration Number: 2007.20126E | SThree Pte Limited Licence Number 16S8216 | Real Licence Number 53132073A)
Award winner of:
International Recruitment Company of the Year by Recruitment International 2016
Life Sciences and Healthcare Recruitment Company of the Year by Recruitment International 2016
Best Overseas Operation by Global Recruiters 2017
Highly Commended for Best Large Recruitment Business 2017