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Senior Regulatory Affairs Officer

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Primary Location: Warsaw, Poland Additonal Locations: Amsterdam, Netherlands,NLD; Athens, Greece,GRC; Barcelona, Spain,ESP; Basel, Switzerland,CHE; Belgrade, Serbia,SRB; Bratislava, Slovakia,SVK; Bucharest, Romania,ROU; Budapest, Hungary,HUN; Copenhagen, Denmark,DNK; Dublin, Ireland,IRL; Espoo, Finland,FIN; Istanbul, Turkey,TUR; Kaunas, Lithuania,LTU; Kiev, Ukraine,UKR; Livingston, United Kingdom,GBR; Ljubljana, Slovenia,SVN; London, United Kingdom,GBR; Madrid, Spain,ESP; Milan, Italy,ITA; Oeiras, Portugal,PRT; Oslo, Norway,NOR; Paris, France,FRA; Prague, Czech Republic,CZE; Reading, United Kingdom,GBR; Riga, Latvia,LVA; Sofia, Bulgaria,BGR; Solna, Sweden,SWE; Strasbourg, France,FRA; Tartu, Estonia,EST; Zagreb, Croatia,HRV; Zaventem, Belgium,BEL; Zurich, Switzerland,CHE Full time R1215517

Job description

Individual contributor with advanced knowledge acquired from several years of experience in the professional discipline, works independently under limited supervision. Prepares and/or reviews regulatory documents to support clinical trial submissions. Independently provides regulatory support for more complex projects.


RESPONSIBILITIES



Acts as a Regulatory Advisor on complex clinical trial projects or programs
Ability to administratively and technically/scientifically review core scientific documentation and feedback gap analysis to customers.
Prepares and maintains core clinical trial dossiers in accordance with applicable regulatory requirements.
Ability to write scientific documents e.g. Investigational Medicinal Product Dossier, Investigator’s Brochure, clinical trial justifications with minimum support of senior staff
Interacts with internal and external clients to provide regulatory guidance and strategic input for clinical trials.
May strategically plan and oversee global country submissions
Can provide support on regulatory business development opportunities and complete Data Informed Protocol Assessments (DIPAs)
Understands the Scope of Work, deliverables and budget for any given project and ensure timelines are met.
Ensures accurate completion, maintenance and adherence to internal systems, databases, tracking tools and project plans in line with agreed SOPs (customer and/or IQVIA).
Deliver regulatory training/presentations as required.


REQUIRED KNOWLEDGE, SKILLS AND ABILITIES



Good understanding of the regulations, directives and guidance supporting clinical Research and Development
Demonstrates comprehensive regulatory/technical expertise
Good negotiating skills and the ability to identify and resolve issues, using flexible adaptable approach
Strong ownership and oversight skills
Demonstrated skills in chairing small meetings
Ability to work on several projects, retaining quality and timelines and can prioritize workload with minimal supervision
Ability to propose revisions to SOPs or suggest process improvements for consideration
Ability to establish and maintain effective working relationships with co-workers, managers and clients
Strong software and computer skills, including MS Office applications


MINIMUM REQUIRED EDUCATION AND EXPERIENCE



Degree in life science-related discipline or professional equivalent plus at least 5 years relevant experience* or high school diploma plus at least 9+ years’ experience* (*or combination of education, training and experience)


PHYSICAL REQUIREMENTS

Extensive use of telephone and face-to-face communication requiring accurate perception of speech
Extensive use of keyboard requiring repetitive motion of fingers
Regular sitting for extended periods of time
Travel will be required

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

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