Senior/ Regulatory Executive
- Singapore, Singapore
- Regulatory Affairs
Regulatory Executive/ Senior Regulatory Executive, Singapore
- Coordinating and submitting new marketing authorisation applications
- Coordinating and submitting post approval changes including variations, renewals etc
- Perform regulatory assessments on potential new products
- To provide assistance in the development of variation submission strategies
- Prepare registration dossier for initial submissions, renewal and variations for pharmaceuticals products
- Provide support in maintaining Good Distribution Practice and other relevant RA matters.
- From time to time, support Local Drug Safety team.
- Review & approve labelling, ensuring that they are in compliance with individual country regulations
- Maintain and monitor database of status, registration etc.
- Liaise with distributor on secondary repackaging requirements
- Product processing and reporting to partners
The successful candidate should possess:
- Bachelor's Degree in Pharmacy or equivalent
- 2-3 years of experience in regulatory affairs within the Pharmaceutical Industry
- Good understating of regulatory practices (Submission and variation), preferably in Health-care products or equivalent
- An exceptional eye for detail required
- Excellent local verbal and written communication skills
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.
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