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Sr Reg Affairs Officer (R1064803)

Keywords / Skills : Sr Reg Affairs Officer (R1064803)

Posted: 2019-06-09

Software Engineer/ Programmer
Posted On
9th Jun 2019
Job Ref code
Job Description

Job Description

Join us on our exciting journey!IQVIA is The Human Data Science Company, focused on using data and science to help healthcare clients find better solutions for their patients. Formed through the merger of IMS Health and Quintiles, IQVIA offers a broad range of solutions that harness advances in healthcare information, technology, analytics and human ingenuity to drive healthcare forward.
Job profile: Senior Regulatory Officer - Maintenance

Technical Skills/Experience
Degree in life science-related discipline or professional equivalent
Minimum of 6 years in international regulatory lifecycle maintenance experience, focusing on marketed products
Experience in regulatory procedures in Europe and/or emerging markets (e.g. variations/renewals/aggregate reports) to support lifecycle maintenance activities
Experience in new MAA applications in Europe and/or emerging markets
Good understanding of pharmacovigilance activities relevant to marketed products
Experience in managing regulatory projects
Interaction with Regulatory Agencies (EU/EMA)
Involvement in regulatory strategy and determination of documentation requirements, timelines, budgets
Preparation of relevant CTD documents to support submissions (mainly Module 1), in collaboration with technical/CMC/Labelling experts
Experience in quality review of technical/ regulatory documents
Able to mentor junior colleagues and to assist in their training and development as appropriate
Able to assist in review and revision of regulatory SOPs / act as reviewer as appropriate

Soft Skills
Excellent verbal and written communication skills in English are essential, including the ability to deliver difficult messages in an appropriate way to client / stakeholders
Be able to manage peaks of workload and prioritise workload with minimal supervision
Ability to work to tight timelines
Open and communicative personality
Good team player
Good negotiating skills
Be able to identify and resolve issues, using flexible adaptable approach
Strong computer skills, including MS Office applications, data and document management systems
Adaptable to change
Cultural awareness

We know that meaningful results require not only the right approach but alsothe right people. Regardless of your role, we invite you to reimagine healthcare with us. You will have the opportunity to play an important part in helping our clients drive healthcare forward and ultimately improve human health outcomes. Whatever your career goals, we are here to ensure you get there! We invite you to join IQVIA

Job ID: R1064803

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