Senior Quality Assurance Officer (Regulatory Affairs)

Malta Island
Permanent
Full-time

9 days ago

We are looking for a detail-oriented Senior Quality Assurance Officer (RA) to support our regulatory operations and ensure continued compliance with applicable regulatory requirements. The role directly reports to the Regulatory Affairs Manager and requires European Regulatory Affairs knowledge to support daily operations as well as projects.Key Responsibilities may include any of the following areas:

Prepare and submit variations to Marketing Authorizations (MAs), including safety-related variations, in accordance with national and EU procedures.
Prepare and manage XEVMPD submissions
Monitor and track product lifecycle management requirements.
Maintain up-to-date regulatory records and databases to ensure traceability and compliance.
Collaborate cross-functionally with internal departments to ensure that regulatory requirements are integrated into company processes.
Management of the Supplier Qualification Process
Support in the external audit programme
Support regulatory inspections, self-inspections and client audits as required.

Candidate Profile

Education: Bachelor’s degree or higher in Pharmacy, Life Sciences, or a related field.
Experience: Minimum of 5 years of experience in Quality Management and/or Regulatory Affairs within the pharmaceutical industry.
Skills:

Solid knowledge of EU and local regulatory requirements.
Strong communication skills with the ability to manage cross-functional collaboration.
Strong organisational skills and attention to detail.

Other Requirements

Applicant must be in possession of a valid work permit.

Benefits

Competitive remuneration package;
Comprehensive health insurance;
Hybrid working arrangements;
Safe and conducive working environment;
On-the-job training and professional development in a state-of-the-art facility equipped with the latest technologies.

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