Regulatory Affairs and Pharmacovigilance Manager (South of Malta) - Quality Control jobs in Malta - February 2024
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Regulatory Affairs and Pharmacovigilance Manager (South of Malta)

Konnekt

Published on 26 Jan 2024

Expired on 25 Feb 2024


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

time
Full Time
Job Type
experience
Middle Management
Experience Level
category
Quality Control
Category
industry
Pharmaceuticals
Industry

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