Our client is a Pharmaceutical Supply Chain Solutions industry. Due to their current expansion plan, they are looking for a Regulatory Affairs Specialistto 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.

We regret that only shortlisted candidate will be notified.

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Regulatory Affairs Executive Healthcare / Pharmaceutical / West