Regulatory Affairs Officer

Posted 11 September by Parkside Office Professional
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Regulatory Affairs Officer

Your main responsibilities will involve:

- Striving to constantly improve the Pharmaceutical Quality System and product quality
- Representing the QA function within Quality leadership meetings, giving expert advice on strategies to maintain/improve quality performance
- Ensures that the Affiliate is in line with the European Guidance on Good Distribution Practise (GDP) for all relevant products
- Reviewing and approving documents that directly affect QA activities
- Responsible for the management of release and updating of Summary of Product Characteristics (SmPC) and Patient Information Leaflets (PIL)

Key accountabilities

- Develops, implements and manages the Quality Assurance policy of the affiliate by ensuring a robust Quality Management System (QMS) is in place
- Quality, risk management, and continuous improvement principles
- Effective investigations and root cause analyses of issues are completed an appropriate Corrective and Preventive Actions are identified and implemented
- Facilitates the conduct of Risk Assessments and the development of Risk Mitigation Plans and monitors mitigation actions
- Establish, implements and manages a documentation system
- Develops and implements a Change Control system management linked to the Corporate QA Change Control management system
- Organises internal audits for the affiliate, in order to evaluate the compliance to local regulatory requirements, and Corporate requirements
- Informs Corporate QA about inspections, and provides the adequate corrective preventive actions to Inspectorates in agreement with Corporate QA
- Involved in writing of all Quality Agreements signed by the affiliate, especially where there is subcontracting regulated activities
- Responsible for the management of release and updating of Summary of Product Characteristics (SmPC) and Patient Information Leaflets (PIL)
- Good Distribution Practise (GDP) compliance - the Affiliate's expect in matters related to the distribution of product
- Contribute proactively to a credible image for the affiliate in the local HealthCare and Medical community

Special Competencies / Other Requirements

- Degree in pharmacy, life science or a recognised healthcare professional degree / qualification
- Good knowledge of Quality Systems Management, GDP, GMP, GCP, Regulatory and
- Pharmacovigilance legislation where appropriate
- Practical experience leading and implementing process development and improvement activities that embed quality and drive continuous improvement
- Challenges and questions ways of working to seek improved processes
- Excellent attention to detail

Parkside Recruitment Ltd is acting as an Employment Business in relation to this vacancy.Parkside Recruitment is an Equal Opportunities Employer.

Required skills

  • Regulatory Affairs

Reference: 38890211

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