At Majeton, weare driven by our commitment to deliver The Right Product for Health. Our team of researchers and clinical experts utilize clinic feedback from practitioners, scientifically researched literature and top quality manufacturing as the foundation for all products.

We are seeking a meticulous and experienced Quality & Regulatory Affairs Specialist to join our team and ensure regulatory compliance, uphold product quality, and oversee vigilance reporting for all of our marketed products.

About The Role

We are seeking a Quality and Regulatory Affairs (QRA) Specialist to support quality and regulatory activities for our products. In this role, you will ensure full QMS, oversee product quality processes, and supporting the full lifecycle management of products within our group.

This position offers potential regional exposure and the opportunity to build a progressive career in the QRA industry.

Key Responsibilities

Quality Assurance (QA)

Assist in implementing and maintaining the company's Quality Management System (QMS).
Handle and manage QRA-related inspections.
Maintain QRA-related licences and compliance.
Manage new and existing supplier management activities.
Manage investigations for deviation, non-conformity, CAPA and complaints.
Review technical documentation and perform basic investigation.

Regulatory Affairs (RA) / Pharmacovigilance (PV)

Lead and/ or manage drug safety detection activities.
Coordinate and deliver internal training to ensure regulatory and quality compliance.

Others

Manage and maintain all documents and records related to QRA, ensure regulatory compliance.
Participate in the preparation of premarket regulatory submissions for commercial distribution.
Ensure accurate records of training, roles and systems used in GxP functions.
Support ad-hoc tasks and cross-functional initiatives when necessary.

Requirements

Degree in Engineering, Life Sciences, Pharmacy, or a related discipline.
Strong documentation, problem-solving, and communication skills.
Exposure to Quality & Regulatory Affairs (QRA) activities, including QMS, SOP development, and inspection readiness.
Familiarity with GDPMDS, GDP, regulatory inspections, and compliance is an advantage.
Experience in regional QRA roles, SME distribution companies, or start-up / fast-growing environments is a plus.
Non-pharmacists with relevant experience in QA, compliance, or pharmaceutical distribution are welcome.
Fresh graduates with a pharmacist licence who are keen to build a career in the pharmaceutical industry are encouraged to apply.

Quality and Regulatory Affairs Specialist