Job Information
IQVIA Regulatory Affairs Specialist - Romania in Bucharest, Romania
We are hiring a regulatory Affairs role and looking for individual contributor who is fully proficient in applying regulatory Affairs knowledge for a well-established and marketed portfolio of pharmaceuticals and biologicals and can work with high sense of ownership under limited supervision.
Essential Functions Regulatory Role
Prepare, review and submit regulatory documentation (for example: CTD/eCTD submissions), as appropriate; follow through post approval commitments.
Meet with Officials in Health authorities were applicable and represent the client.
Act as a Subject matter expert implementing Regulatory knowledge for post marketing approvals and well-established marketed products in Medical device, pharmaceutical and Biological innovative products in, Lifecycle Maintenance/ Marketing Authorization Transfers/ Labeling/ Publishing/ Complex cross country change assessments/Market authorization approvals/ Gap analysis and assessments safety variations and manufacturing site renewals or as applicable.
Up to date with regulatory intelligence information in different health authorities, communicating to clients and working groups to define best strategy and anticipate future trends.
Update client regulatory compliance systems and ensure following the metrics and SOPs .
Understands the Scope of Work, deliverables and management of budget for several given projects and manages workload as appropriate.
May give guidance to junior colleagues, including feedback on the quality of technical documents, and may assist in their training/ development/on-boarding.
Network with clinical operation, IMS and business development and other cross-functional teams in additional to maximize external networking with potential clients and stakeholders to identify potential opportunity and bring more business.
• May act as reviewer for regulatory standard operating procedures, as assigned and appropriate.
• Performs other tasks or assignments, as delegated by Regulatory management.
Providing support in risk mitigation, in planning corrective/preventive actions, and guidance for improvement as needed.
May provide assistance during audits and regulatory inspections to the operational teams to the extent agreed.
Prepare periodic reports to stakeholders on quality related matters, risk assessments and specific improvement initiatives.
Upon agreement with the Line Manager: Perform any other reasonable tasks as required by the role.
Qualifications
Degree in pharmaceutical science is a must. Professional post graduate degree is a plus
High English and Romanian proficiency
Good understanding of the regulations and related guidelines
This is for both generic and innovative medicine
Capacity to read and understand high level SOPs, e-trainings, work easily on Veeva and collaborate according to ways of work
Sound working knowledge of medical terminology, Standard Operating Procedures (SOPs), International Conference on Harmonization (ICH), Good manufacturing Practice (GMP), applicable regulatory requirements,. Knowledge of National Regulations and (CMC).
Experience with product lifecycle, renewals, post-market authorization.
IQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry. We believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. Learn more at https://jobs.iqvia.com
IQVIA is a world leader in using data, technology, advanced analytics, and expertise to help customers drive healthcare – and human health – forward. Together with the companies we serve, we are enabling a more modern, more effective and more efficient healthcare system, and creating breakthrough solutions that transform business and patient outcomes.
To get there, it takes diverse skills and a curiosity to explore new possibilities. No matter your role, everyone at IQVIA, including our colleagues at Q² Solutions, contributes to our shared goal of improving human health. Thank you for your interest in growing your career with us.
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