Regulatory Affairs and Pharmacovigilance Manager (South of Malta)

Our client operates in the pharma industry and as they are growing they would like to employ a Regulatory Affairs and Pharmacovigilance Manager role

The Role

• Plan and manage regulatory activities related to assigned projects that span technical areas
• Collaborate with international colleagues to support market access for product portfolio
• Act as Malta point of contact for compliance questions and responsibilities for products
• Assist in developing and implementing strategies for the earliest possible approvals/clearance of regulatory submissions associated with assigned projects
• Manage the preparation, including writing as necessary, assembly, review, and timely submission of regulatory dossiers as required for investigation and registration of products in the Malta and abroad
• Ensure regulatory submissions are maintained in compliance with regulatory requirements
• Act as local QPPV
• Conduct and Manage PV Operations activities to ensure compliance with regulatory requirements and maintain regulatory inspection readiness in collaboration with Quality Assurance
• Participate on project teams and provide expertise on regulatory and PV matters
• Develop and maintain current regulatory knowledge and advise management of significant developments
• Prepare and maintain regulatory archive. Work with external regulatory consultants/CRO’s as required

• Bachelor’s degree or higher in a life science required – healthcare professional preferred
• Minimum 5 years of experience in Regulatory affairs the pharmaceutical industry (Critical care and Oncology products)
• Minimum 2 years recent experience in pharmacovigilance/drug safety
• Knowledge/experience with regulatory requirements for other regions also desirable
• Working knowledge of GMP, GLP, and GCP regulations as well an understanding of the pharmaceutical product life cycle
• Excellent oral and written communications skills are a must as are superior planning skills
• Experience with CTD/eCTD. Experience with publishing documents in Adobe Acrobat Professional. Working knowledge of EU and ICH regulatory guidance and regulations
• The candidate should be detail-oriented, a self-starter, and be comfortable with broad responsibilities in an entrepreneurial, fast-paced, small company environment

• Have good basis in English and Maltese
• Be able to travel within the region EMEA and India,
• Must have excellent communication skills in both English and Maltese