Senior Regulatory Affairs Associate

• Handle Pre-market and Post-market responsibilities including but not limited to special authorisation applications, product registration, product recall, update changes to product registrations throughout its life cycle.
• Appointed DCH PV Officer, responsible for PV-related activities including but not limited to PV training for DCH employees, regulatory reporting, participate in PV audits, closing audit non-conformance.
• Local literature monitoring and supporting pharmacovigilance in this respect.
• Responsible in handling and managing controlled drugs.
• Review and approve marketing and promotion materials. Handle registration and maintain database of sales and advertisement permits issued by HSA.

• Training on relevant procedures and regulatory requirements to internal and external parties when required.
• Support Commercial Department in business development such as product evaluation and pre-launch activities.
• Provide guidance and arrange job rotations for pre-registration trainees and interns.

• Support clinical product training and initiatives where needed.
• Support technical training to sales and marketing where needed.
• Manage pre-registration trainees and interns including liaison with internal party (HR, Marketing) and external organizations such as Singapore Pharmacy Board and NUS.
• Allocate customer/product groupings and disposal classification in New Customer and Item Creation Forms in compliance to HSA and NEA regulations.

• Degree in Pharmacy and Registered Pharmacist.
• Preferably 2 to 4 years of working experiences in government hospital or regulatory affairs.
• Able to work independently with minimal supervision and as part of a team.
• High degree of flexibility, organized and detail-oriented.
• Abilities to work under pressure, handle multiple priorities and meet strict deadlines.
• Excellent written and verbal communication skills.
• Strong attention to detail and analytical skills.

Only shortlisted candidates will be notified.

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Please do not submit your application to [email protected] and [email protected]. Applications received through these email addresses will not be taken into consideration.