Regulatory Affairs Officer 1 (R1089272) in Sofia, Bulgaria at IQVIA™

Date Posted: 9/30/2019

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Job Description

IQVIA™ is the leading human data science company focused on helping healthcare clients find unparalleled insights and better solutions for patients. Formed through the merger of IMS Health and Quintiles, IQVIA offers a broad range of solutions that harness the power of healthcare data, domain expertise, transformative technology, and advanced analytics to drive healthcare forward.

We seek for a candidate providing regulatory support and oversight for our operational team. We are looking for a candidate in Eastern EU (eg Hungary, Bulgaria, Poland etc).


• Collate and process requirements for countries under his/her responsibility.
• Assist with creation and/or review of country-specific regulatory documentation to enable study initiation and maintenance, as required.
• Assist with submissions to RA, EC and Data Protection Authority, if applicable
• Prepare master informed consent form and patient information sheet if applicable
• Review country-specific  informed consent form and patient information sheet if applicable.
• QC review core document package ensuring compliance with international and local legislative requirements
• Coordinate questions from competent authorities and subsequent responses
• Contribute to the collection, interpretation, analysis and dissemination of accurate regulatory intelligence to support assigned studies and wider organisation, as required.


Good understanding of laws and related guidelines, as appropriate

Good, solid interpersonal communication (oral and written) and organisation skills

Strong software and computer skills, including MS Office applications

Demonstrates self-motivation and enthusiasm

Ability to work on several projects, with direction from senior staff as appropriate

Ability to follow SOPs consistently; provides independent thought to assist in process improvements

Ability to make decisions on discrete tasks under senior supervision

Ability to establish and maintain effective working relationships with co-workers, managers and clients


Degree in life science-related discipline or professional equivalent plus at least 1 year relevant experience* or high school diploma plus at least 5-7 years experience* (*or combination of education, training and experience)


Extensive use of telephone communication requiring accurate perception of speech

Extensive use of keyboard requiring repetitive motion of fingers

Regular sitting for extended periods of time

Join Us

Making a positive impact on human health takes insight, curiosity, and intellectual courage. It takes brave minds, pushing the boundaries to transform healthcare. Regardless of your role, you will have the opportunity to play an important part in helping our clients drive healthcare forward and ultimately improve outcomes for patients.

Forge a career with greater purpose, make an impact, and never stop learning.

Job ID: R1089272