Regulatory Affairs Specialist - Bucharest, Ilfov, 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

• Act as a Regional Regulatory affairs lead and strategist on complex regulatory projects, who is able to create and follow through project strategy on country level

• 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.

• Establish strong relationships with stakeholders; present regulatory projects and progress, discuss issues and customer comments.

• 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

• Support pricing reg-intal in the country and provide advice as needed, prepare pricing submission packages as required and based on client request and variation requirements.

• 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

• May present to clients on complex regulatory processes at large full-service bid defense meetings; and preparation for new opportunities.

• 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

• At least 3-5 years relevant experience in regulatory national and/or regional scope of work  

• Good understanding of the regulations and related guidelines in the region

• Good understanding of Regulations (Pharmaceutical and Biological is a must), Medical device is a plus

• Good knowledge of different regulatory dossiers : CTD, e-CTD, NeeS, ..is a must.

• Capacity to read and understand high level SOPs, e-trainings, work easily on veeva and collaborate according to ways of work

• Possesses a specific regulatory and technical expertise;

• 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).
• Knowledge of Pharmaceutical industry operations, the link of change controls to production and supply and SKU sharing
• Good, solid interpersonal communication and organization skills;

• Ability to establish and maintain effective working relationships with coworkers, managers and clients;

• Strong software and computer skills, including Microsoft Office (power BI, Onenote, SharePoint, planner, Word, Excel, Teams, Visio), publishing applications and tools, as applicable;

• Strong software knowledge of finance and planning systems (oracle, SAP, …). Strong knowledge of Veeva vault

• Demonstrates self-motivation and enthusiasm, high sense of ownership

If you think you are able to bring to the role ability to adapt rapidly changing environment, problem solving attitude and constant readiness to upgrade, please apply.

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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