Commercial Regulatory Affairs Manager

2 weeks ago

Singapore LABGISTICS ASIA PTE. LTD. Full time

**Responsibilities**:

- Lead and supervise the SG Regulatory Affairs (RA)
- Accountable for all Products Registration, renewals, and amendments
- 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.
- 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

**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.

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