Regulatory Assistant / Microbiologist Assistant (Pharma MNC, Office Hours 5 days, Training provided)
- Reviews and approves regulatory submissions to the HSA to ensure compliance with applicable regulations and guidance's.
- Interacts with various departments as needed on regulatory issues and/or strategy.
- Effectively guides, communicates and implements determined strategy with the appropriate departments and/or employees.
- Review and approve change notices, specifications, batch records, standard test methods, etc.
- Implements policies to assure on-going compliance of Regulatory Affairs activities.
- Assesses impact of new regulations and suggests appropriate changes to business processes/policies as necessary.
- Interacts with the HSA to facilitate approval of the regulatory submissions.
- Maintains awareness of all regulatory activities on assigned projects.
- Works to minimize regulatory issues and helps prevent unnecessary regulatory delays.
- Interacts with outside consultants and or contractors as needed.
- Troubleshoots data and resolves problems with technical issues such as test methods and instrumentation.
- The successful candidate will become a subject matter expert on a variety of microbiological analyses of finished products and/or raw materials and may complete entry, review, and/or approval of data in a computerized database.
- The tests and assays are performed as a function of a high output microbiological testing laboratory.
- The candidate will assist in the overall operation of the laboratory including: continuous improvement of current test assays and methods, assisting with development and validation of new test methods, overseeing qualification of new laboratory equipment, evaluation of testing and lab practices against regulatory standards to ensure continued compliance, leading deviation investigations and corrective action/preventative action creation and execution, and creation and revision of standard operating procedures.
EDUCATION AND EXPERIENCE
- Min Diploma in any science related field
- No experience needed, full training provided
- Minimum 2 - 3 years of experience in either domestic and regional regulatory affairs would have an advantage
- Familiar with regulatory affairs such as NDA, variation and renewal of product registrations in Pharmaceutical industry (manufacturer or distributor) would be at an advantage
- Pharmacovigilance (or safety monitoring/reporting) experiences preferred but not mandatory
If you are interested in the position, do kindly drop your most updated resume to [Click Here to Email Your Resume] (Attn: Regulatory Affairs / Microbiologist- Leon)
Leon Leong De Cong
EA License: 99C4599
Recruit Express Pte Ltd
Recruit Express Pte Ltd