Regulatory Affairs Executive – Healthcare / Pharmaceutical / West

Our client is a Pharmaceutical Supply Chain Solutions industry. Due to their current expansion plan, they are looking for a Regulatory Affairs Specialist to join their team, in hopes of developing the current high performing team. They are located in West.

Job Responsibilities:

• Manage regulatory licence applications, renewals and maintenance.
• Prepare documents for new product launches and licence submissions.
• Prepare and review product registration dossiers and variations.
• Liaise with regulatory authorities and government agencies on regulatory matters.
• Maintain accurate records of product licences, registrations and regulatory documents.
• Prepare and submit required regulatory reports, records and transactions.
• Work with QA and Operations teams to ensure proper product documentation and traceability.
• Review SOPs, work instructions and procedures to ensure regulatory compliance.
• Support regulatory matters relating to Therapeutic Products, Medical Devices, Controlled Drugs and other regulated products.
• Coordinate with internal teams on registrations, renewals, amendments and regulatory projects.
• Perform other ad-hoc duties as assigned.

Requirements:

• Minimum Degree in Pharmacy with relevant Singapore Pharmacy Board.
• Minimum 3 years of relevant experience in pharmacy practice.
• Familiarity with Singapore regulatory requirements relating to Medical Devices, Controlled Drugs and Poison Licenses.
• Experience in regulatory affairs, product registration or licence management will be an advantage.
• Good understanding of regulatory documentation and submission processes.

Interested candidates who wish to apply for the advertised position, please click APPLY NOW or email an updated copy of your resume/cv.

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