Regulatory Affairs Officer 1 (R1103039) in Sao Paulo, Brazil at IQVIA™

Date Posted: 10/29/2019

Job Snapshot

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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.

Technical Skills/Experience

  • Degree in life science-related discipline or professional equivalent
  • Experience in regulatory lifecycle maintenance, focusing on marketed products
  • Preferably has experience of Marketing Authorisation transfer procedures in Europe and/or emerging markets 
  • Preferably an understanding of pharmacovigilance activities relevant to marketing authorization transfers
  • Experience of preparation of relevant CTD documents to support submissions (mainly Module 1), in collaboration with technical/CMC/Labelling experts
  • Able to assist in review and revision of regulatory SOPs / act as reviewer as appropriate
  • Strong written and verbal communication skills including good command of English language

Soft Skills

  • Excellent verbal and written communication skills in English are essential
  • Well organized
  • Be able to manage peaks of workload and prioritise workload with supervision
  • Ability to work to tight timelines
  • Open and communicative personality
  • Good team player
  • Some negotiating skills
  • Ability to identify and flag issues
  • Strong computer skills, including MS Office applications, data and document management systems
  • Adaptable to change
  • Cultural awareness

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: R1103039