Our client is a well-known MNC in analytical and diagnostics field. They are looking for Singapore Pharmacist to be the Primary License Holder for controlled drugs (CD), poison and psychotropic substances (PS), handle QA activities and assist in regulatory activities.
- License holder for controlled drugs, poison and psychotropic substances
- Application and maintenance of the licenses for controlled drugs, poison and psychotropic substances in Singapore. Fulfil the roles and responsibilities as defined in the Misuse of Drug Act, Poison Act, Health Products Act.
- Perform regulatory surveillance of relevant regulations in SEA and manage changes that could have business impact or regulatory risk.
- Ensure timely reporting of declaration records, on-renewal of the licenses and new application according to registration plan.
- Act as lead process owner for SOP management of controlled drugs, poison and psychotropic substances. Ensure control measures are in place for ordering and supply to authorized customers/distributors. Provide training on any changes to update the local stakeholders.
- Work closely with regulatory bodies for audits and also resolve any issues or changes to ensure smooth operation.
- Ensure proper documentation of records in accordance to the relevant regulations.
- Regulatory Related Activities
- Align product registration submissions according to commercial plan and regular reporting of status and/or challenges.
- Post-market support including timely change notification submission and FSCA reporting. Advise stakeholders on impact and implement system control points as necessary.
- Management of IFU translation and assign as document controller for translated IFU.
- Trainer for Global Complaint Handling process.
- Maintain ISO9001:2015 and GDPMDS certification & other Quality Assurance Related Activities
- Assign as Document controller.
- Maintain RAQA related SOP/WI to be in line with ISO9001:2015 and GDPMDS.
- Conduct or support internal audits, supplier assessment and Quality Management Review. Provide Regulatory Affairs support for external audits and inspections.
- Pharmacist Degree recognized by the Singapore Pharmacy Council and is registered as Pharmacist in Singapore
- Candidates with no related working experience is welcome to apply
- Build and maintain excellent working relationships in a multicultural environment
- Attention for details
- Good problem solving and critical thinking
- Excellent planning/organizing skills
Please contact Ewen Poh at +65 6950 0365 or firstname.lastname@example.org for a confidential discussion
EA License no: 16S8066 | Registration no: R1550486
Only successful candidates will be notified.