Commercial Regulatory Affairs Manager
at LABGISTICS ASIA PTE LTD
Singapore, Southeast, Singapore -
Start Date | Expiry Date | Salary | Posted On | Experience | Skills | Telecommute | Sponsor Visa |
---|---|---|---|---|---|---|---|
Immediate | 24 Jun, 2024 | USD 8000 Monthly | 25 Mar, 2024 | 3 year(s) or above | Working Experience,Regulatory Affairs,Medical Devices | No | No |
Required Visa Status:
Citizen | GC |
US Citizen | Student Visa |
H1B | CPT |
OPT | H4 Spouse of H1B |
GC Green Card |
Employment Type:
Full Time | Part Time |
Permanent | Independent - 1099 |
Contract – W2 | C2H Independent |
C2H W2 | Contract – Corp 2 Corp |
Contract to Hire – Corp 2 Corp |
Description:
REQUIREMENTS:
- Degree in Medical Science or related discipline
- Pharmacy Degree registered with Singapore Pharmacy Board
- At least 4 years related experience.
- Familiar with the registration requirements for Form A Poison License and Controlled Drug License / Therapeutic Products / Medical Devices
- Able to communicate fluently in written and verbal English.
- Working experience as Pharmacist for at least 3 years
- Well verse on Power point presentation.
- Business engagement under Regulatory Affairs is an added advantage.
- Experienced on HSA audits and knowledge on ISO13485, ISO90001 and SS620 are an added advantage.
- Knowledge on secondary redressing is required.
Responsibilities:
- Lead and supervise the SG Regulatory Affairs (RA)
- Accountable for all permit & licenses application, renewals, and maintenance under the company
- Accountable for all Products Registration, renewals, and amendments
- Guide and train the Regional Regulatory Affairs team on the preparation of documents for license applications and maintenance.
- Communicate with regulatory authorities as well as regional RA team regarding regulatory affairs matters such as product registrations, changes in existing products and renewals.
- Advise internal stakeholders on regulatory guidelines and be responsible for new product registration and license renewal progress.
- Be the main liaison with regulatory and government bodies regarding Regulatory Affairs
- Be the main liaison for inter-department alignment of work processes/procedures as required.
- Responsible for local permit & licenses application, renewals and maintenance
- Review and prepare product dossiers for submission, including variations (therapeutic products, medical device etc.)
- Maintenance and filing of current product licenses and registration documents.
- Liaise with QA and Operations on the periodic and routine review of logs and records for movement and traceability of products.
- Ensure the compliance of our Standard Operating Procedures (SPs/SOPs/WIs) in accordance with local regulations & certified bodies standards.
- Attend to all regulatory matters relating to the sales and distribution of Medical Devices, Radioactive Therapeutic Products, Controlled Drug and Therapeutic.
- Submission of reports and transactions of our companies’ assigned licenses and permits required by respective.
- Participate in meetings with the local Regulatory Affairs team to review status of registrations, renewals and amendments including projects and other activities of the department.
- Participate in all RFQ/RFI and able to provide guidance to all potential clients with regards to registrations, requirements, timeline, pharmacovigilance, etc.
- Familiar with HSA requirements and Guidelines.
- Carry out any other duties assigned from time to time by the Director or Business Manager/General Manager
REQUIREMENT SUMMARY
Min:3.0Max:4.0 year(s)
Pharmaceuticals
Pharma / Biotech / Healthcare / Medical / R&D
Clinical Pharmacy
Graduate
Proficient
1
Singapore, Singapore