Due to expansion across Europe within our Regulatory function we are looking for Regulatory Professionals in based in UK, Europe, the Nordics or Russia
IQVIA Biotech is the division of IQVIA which deals with small to medium size biotech companies, most of our employees are involved in clinical research and we are expanding our regulatory affairs team as part of an overall company expansion.
We are looking for candidates at all levels who have experience of regulatory affairs clinical trials submissions for Medical Devices and In-Vitro Diagnostic (IVD) products. We are interested in applicants from the UK, Europe, Nordics, and Russia. The role is home based.
To provide regulatory and quality support to select clinical research projects involving investigational drugs, medical devices, biologics, or new medical procedures. To provide strategic regulatory guidance and information to projects; to acquire pertinent regulatory information from agencies and organizations; to support regulatory agency interactions, communications, and submissions; and to review project regulatory documentation to ensure compliance with applicable regulatory regulations and guidelines.
Essential Job Functions, Duties and Responsibilities
- Assist Associate Director, Regulatory Affairs, in assuming primary or secondary regulatory responsibility for assigned clinical research projects by providing to the project team regulatory information, guidance, training, support and strategic planning based on applicable regulations and guidance’s issued by the applicable regulatory agency(ies).
- Identify and interpret regulations, guidelines, and other pertinent information issued by applicable regulatory agencies and other regulatory organizations.
- Review protocols, consent forms, reports, scientific documents, publications, and related papers, etc., as appropriate for various clinical research projects to ensure compliance with regulations.
- Ensure the compilation and maintenance of pertinent documentation (e.g., files) required for regulatory compliance for assigned clinical research projects.
- Serve as a member of groups, teams, or committees related to regulatory affairs, and quality assurance or other designated IQVIA Biotech activities, as appropriate.
- Serve as IQVIA Biotech liaison with central IRBs.
- Perform other related duties as assigned.
Knowledge Skills and Abilities
- Working knowledge of and aptitude for activities related to regulatory affairs and quality assurance, both domestic and ideally also international.
- Familiarity with or ability to become familiar with regulatory documents, general contents, organization and the methods of filing and tracking.
- Familiarity with or ability to become familiar with principles of Good Clinical Practice, Good Laboratory Practice and Good Manufacturing Practice., ISO standards.
- Extensive knowledge of clinical research; knowledge and familiarity with 21CFR11 and EDC systems.
- Experience in preparation of audit plans and checklists against applicable standards, execution of audits, and preparation of comprehensive written audit reports.
- Good interpersonal skills with the ability to communicate effectively, both orally and in writing, with all levels of staff, and with the public.
- Ability to be detail oriented with background adequate to deal with scientific issues related to technical regulations and SOPs.
- Ability to read and synthesize technical material and to prepare clear and concise written documents.
- Computer literate at a level allowing utilization of event tracking programs, data loading and information processing related to regulatory affairs and quality assurance.
- Experience of regulatory affairs submissions for clinical trials in at least one country is essential.
- Requires Bachelor's degree, science degree preferred or equivalent level of education and work experience.
- Excellent analytical and communication skills, particularly writing skills, are essential.
- Demonstrated computer literacy is required.
Please submit your CV’s/application in English.