► Medical Manufacturing Industry
► Office Hour 8am – 5.15pm (Mon – Fri)
► Working Location: Tai Seng
► 1 year contract
Responsibilities:
- Manage product registration, support the planning and execution of submission strategies for all regulatory across Asia, Middle East, USA and Africa
- Responsible of evaluating, compilation and preparation of registration dossiers and preparing registration applications for submission to regulatory agencies or to commercial partners
- Maintain current knowledge base of existing and emerging regulations, standards or guidance documents
- Monitor and communicate new and changing medical product guidelines regulations in a timely manner
- Ensure that all related registration documents (including compiling product technical file are complete and up to date)
- Maintain system for tracking changes in documents submitted to agencies
- Assist and review product labelling, promotional materials and advertisement for compliance with regulatory requirements
- Liaise with HSA and foreign authorities on matters pertaining to regulatory activities, licenses and permits
- Ensure that the in-house quality standards and specifications are maintained and in accordance with regulatory standards and cGMP
- Coordinate with cross functions departments for the preparation and review of registration documents and submissions
- Liaise with external parties for R&D projects
- Conduct new product/ new source evaluation in the R&D laboratory
- Conduct/ manage product sensory evaluation as required
Requirements:
- Diploma or Degree in Pharmaceutical/ medical/ related science with 2 year experience in Regulatory Affairs with a medical company (OTC products, traditional medicines, herbal medicines), 1 year experience with formulation lab work
- Excellent communication skills and detail oriented
- Positive attitude and good interpersonal skills
- Self-motivated, able to work independently as well as in a team
To apply, please visit to www.gmprecruit.com and search for Job Reference: 18757
To find out more about this opportunity, please contact Summer at summer.thung@gmprecruit.com
We regret that only shortlisted candidates will be notified.
GMP Technologies (S) Pte Ltd | EA Licence: 11C3793 | EA Personnel: Summer Thung | Registration No: R1871138
