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You will be responsible for regulatory activities required at a country level for medical devices and medicinal products, including maintenance and approvals, marketing authorization transfers, communication with the Health Authority, artwork approval etc. ensuring regulatory compliance in the applicable markets: Lithuania, Latvia, Estonia.

As part of the IQVIA Global Regulatory Affairs department, you will be working with our clients – global pharmaceutical companies.

Key Responsibilities

• Manage the local regulatory submission preparation in collaboration with internal and external stakeholders based on the agreed strategy for designated countries
• Submit submissions such as notifications/ renewals/ variations/ new applications filings/ MAH transfers to the local Health Authority and follow up on the local regulatory approval process for Lithuania, Latvia, Estonia
• Preparation, translations from English of local Product Labelling (e.g. SmPC, PIL), in local language for Lithuania, Latvia, Estonia
• Artwork and promotional materials review and approval in client systems
• Manage multiple medical devices and pharmaceutical products
• Keep up to date on latest local pharmaceutical legislation, relevant guidelines and requirements

Qualifications

• Bachelor’s Degree in Life Sciences or professional equivalent
• 3+ years regulatory expertise (grade 140) in country-specific requirements for medical devices and medicinal products including the creation of country-specific regulatory submission documents and coordinating delivery to submission plans, artwork review, communication with the Health Authority
• Experience with working in a large regulatory organization where some tasks are managed centrally and some at a local level
• Knowledge of local (Lithuania, Latvia, Estonia) pharmaceutical legislation, relevant guidelines and requirements
• excellent organization and communication skills,
• ability to work to tight timelines
• Good team player
• Excellent written and verbal communication skills in English and native one of languages: Lithuanian, Latvian or Estonian
• Strong computer skills, including MS Office applications, and preferably, experience with Regulatory Information management and artwork systems

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com