Regulatory Affairs Consultant (2-3 days work week)/ Pharmaceutical MNC

at  Integrity Partners Pte Ltd

Our client is looking for a part-time regulatory affairs candidate with a registered pharmacy background. We will only consider candidates who can work on a part time basis for 2-3 days a week.

REQUIREMENTS:

• Pharmacy Degree / Background in Pharmacy
• 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.

• Accountable for all permit & licenses application, renewals, and maintenance under the company
• 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.
• 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.
• Submission of reports and transactions of our companies’ assigned licenses and permits required by respective.
• 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.