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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
Skill-sets and Requirements
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
Education & Experience
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
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
Skill-sets and Requirements
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
Education & Experience
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
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