Highridge Pharmaceuticals Limited,a leading pharmaceutical importer and distributor is seeking a quality assurance and regulatory pharmaceutical technologist to join our dynamic team. This is an exceptional opportunity to contribute to a high performing team and ensure company compliance to industry standards.

• Support regulatory activities involving new dossier submissions, medical devices and dietary supplements applications, handling of product variations and renewal submissions and liaising with the regulatory authority to obtain timely approvals
• Ensure all regulatory licences and approvals are valid and up-to-date
• Staying abreast with the regulatory requirements and guidelines of the country.
• Assist in logistics and ensure timely applications and approvals of import permits and IDFs
• To coordinate, prepare and compile bid submission documents in relation to tendering/bidding activities, tender questionnaires and pre-qualifications
• Ensure that quality assurance and quality control (QA/QC) processes are in place and maintained by strict compliance to SOPs throughout the warehouse.
• Review periodically to ensure that all standard operating procedures reflect the most up-to-date, internationally accepted practices in accordance with GDP and GWP and ensure compliance with evolving innovations or changes to processes or products.
• Ensure the compliance of the warehouse to Environment, Health & Safety as well as Good House Keeping Practices.
• Conduct self-inspections in conjunction with the Warehouse Manager according to required standards (GDP/GWP)
• Ensure that Temperature Reports, Pest Control Reports, Housekeeping Reports and Incident Reports are kept up to date.
• Organize biannual self-inspection and annual internal quality inspection to ensure the warehouse is always in an audit-ready state.

Proven experience (5+ years) in clinical, regulatory department in the pharmaceutical field.

• Strong knowledge of PPB processes for product registrations, retentions, and permits.
• Experience with compilation of tenders for public institutions.
• Preferably registered with PPB and have excellent grasp of the local regulations of Pharmacy and Poisons Board (PPB) and KMLTTB.
• Excellent leadership and team management skills, with the ability to motivate and develop a diverse group of professionals.
• Exceptional organizational, problem-solving, and analytical abilities, with a keen eye for detail.
• Effective communication and interpersonal skills, capable of collaborating with multidisciplinary teams.
• Proficiency in using online portals including Kentrade, ICMS and PPB.
• Flexibility to adapt to changing priorities and handle multiple projects simultaneously

If you are a dynamic and results-oriented individual with a passion for pharmaceutical regulatory affairs, we invite you to apply for this exciting opportunity. Please submit your resume, cover letter, and any other relevant documents to [email protected] In your cover letter, briefly outline your experience and highlight your accomplishments.

Application deadline is on 9th June 2024, Only shortlisted candidates will be contacted.