• Regulatory Affairs Officer Jobs in Argentina - 25368682

  • Iqvia
  • Argentina
  • Save Job
  • 5 - 8 Years
  • Posted : above 1 month

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
Minimum of 5 years in regulatory affairs and 3 years experience in preparation / writing of CMC documents, variations and lifecycle maintenance experience, focusing on marketed products
Experience in regulatory submissions for biologics and biosimlars is required
Experience in new MAA applications in Europe and/or emerging markets an advantage
Experience of involvement in regulatory strategy and determination of documentation requirements, timelines, budgets
Preparation of relevant CTD documents to support submissions (mainly Module1, 2 and 3), in collaboration with technical/CMC/Labelling experts
Experience in quality review of technical/ regulatory documents
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
Well organised
Be able to manage peaks of workload and prioritise workload with some supervision
Ability to work to tight timelines
Good team player
Ability to identify issues and contribute to their resolution
Strong computer skills, including MS Office applications, data and document management systems
Adaptable to change
Good communication and negotiating skills

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 R1107144

Profile Summary:

Employment Type : Full Time
Eligibility : Any Graduate
Industry : Consulting Services
Functional Area : IT Software : Software Products & Services
Role : Software Engineer
Salary : As per Industry Standards
Deadline : 09th Jun 2020

Key Skills:

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