Job Description
The A.M. Mangion Group of Companies is an organization operating in Malta and the MENA region. We are leaders in the healthcare sector and pride ourselves in being a true partner of the world’s leading multinationals in the areas of pharmaceuticals, medical devices, consumer and OTC goods, skin and beauty care. We are also a major player in the Pharmacy and Clinic business.
With more than forty years of experience in the healthcare sector, the A.M. Mangion Group is an environment of positive energy, focused on innovation and dedicated to enhancing life. Critical to us being able to achieve our mission is our ability to stay true to our core values these being Trust, Loyalty, Competence, Commitment and Accountability, this reigns true in not just our corporate realm but also in relation to our approach to people.
Are you a strategic, detail-oriented professional ready to make a significant impact in the healthcare sector? We are seeking an experienced and driven Head of Regulatory Affairs to lead our Regulatory Affairs Department. The successful candidate will also serve as the Responsible Person for Good Distribution Practice (GDP). Reporting directly to the CEO, this role is central to our mission of ensuring the safe, compliant, and efficient distribution of our healthcare products.
Main duties and responsibilities
- As Head of Regulatory Affairs, you will:
- Oversee all regulatory activities, ensuring adherence to compliance standards while maintaining the Quality Manual, covering all processes detailed in the company’s standard operating procedures (SOPs).
- Ensure compliance with applicable health regulations by conducting regular screenings, while also fulfilling all responsibilities outlined in the EU GDP guidelines.
- Develop and implement strategies to optimize our regulatory position with the local Health Authorities, product suppliers and customers and support business growth.
- Lead and mentor a team of regulatory professionals, fostering a culture of excellence and innovation.
- Host audits conducted by the company’s Marketing Authorization Holders (MAHs) and manage inspections from the local Health Authority.
- Maintain accurate physical and digital documentation systems.
- Conduct regular training sessions on current and updated SOPs and policies for both in-house and third-party employees.
- Perform self-inspections and internal audits to identify and address potential gaps in the company’s operating procedures.
- Conduct risk assessments before implementing new or updated procedures.
- Present regular progress reports to the CEO and COO.
- Occasionally travel abroad to participate in training programmes and to undertake responsibilities commensurate with the role.
- As the Responsible Person for GDP, you will:
- Ensure all distribution activities meet GDP requirements, maintaining the quality and safety of products throughout the entire supply chain.
- Work closely with logistics, supply chain, medical affairs, and sales teams to implement best practices and ensure compliance with EU GDP guidelines.
- Serve as the main point of contact for regulatory bodies and the company’s Market Authorization Holders (MAHs), maintaining high standards of compliance and reporting.
- Oversee change controls, manage deviations, and implement CAPAs.
- Handle product quality complaints and manage product recalls as needed.
Skills and Competences
- In possession of a Bachelor’s or Master’s degree in Pharmacy.
- Hold a valid warrant to practice as a Pharmacist in Malta.
- Prior experience in regulatory affairs, ideally with a solid understanding of GDP and guidelines set by the European Medicines Agency (EMA).
- Strong leadership, communication and problem-solving skills.
- Self-motivated and capable of working independently as well as part of a team, with the ability to perform effectively under pressure and meet deadlines.
Why Join Us
- Opportunity to work with a leading healthcare company.
- Supportive team environment with opportunities for professional development and career growth.
- Modernised premises with free on-site parking facilities.
- Flexible working environment.
Kindly send your CV and covering letter by not later than 12th December 2024 via the apply button below.
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