This position has responsibility for Regulatory Affairs within Malaysia, Singapore and Brunei.
This includes :
Support regulatory affairs team on other regulatory affairs matters especially those which are required from personnel based in Singapore.
Ensure minimal supply disruption from regulatory affairs scopes.
Ensure required licenses are maintained and renewed on time.
Jobscope
Manage preparation of regulatory documents, dossiers, and applications for OHC projects.
Support RA team to manage artworks and upkeep Veeva database for OHC portfolios including but not limited to submission dates, approval dates and submission dossier.
Assist RA manager to apply and / or maintain all relevant licenses.
Ensure supply continuity during Maternity Cover period including requesting approval from RA lead and relevant Health Authorities for supply exemption (if required).
Review and approve local repacking application form in Veeva system.
Requirements
Bachelors degree in Pharmacy, Life Sciences, or a related field, with 1-2 years of Regulatory Affairs experience in pharmaceuticals or consumer health.
Knowledge in dossier preparation, artwork management, and regulatory databases is an advantage
Knowledge of regulatory submission and license maintenance processes in Singapore, Malaysia, and / or Brunei is an advantage
Strong attention to detail and organizational skills
Candidates with no prior work experience may be considered
Able to commit to contract term and commence 1 Dec
We regret that only shortlisted candidates will be notified.
GMP Technologies (S) Pte Ltd | EA Licence : 11C
This is in partnership with the Employment and Employability Institute Pte Ltd (e2i).
By applying for this role, you consent to GMP Recruitment Services (S) Pte Ltds PDPA and e2is PDPA.
#J-
Executive • Queenstown, New Zealand