Offer summary

Qualifications:

Bachelor’s Degree in Life Sciences or equivalent., At least 3 years of regulatory experience with EU medicinal product requirements., Experience in preparing regulatory submission documents and coordinating submission plans., Fluency in English and German, with strong communication skills..

Key responsibilities:

Manage local regulatory submissions for Germany, Switzerland, and Austria.

Coordinate with stakeholders to ensure regulatory compliance and approval processes.

Translate and prepare product labeling in German for local markets.

Review artwork and promotional materials for compliance and approval.

Job description

Regulatory Affairs Specialist with German and English language

Location: Poland

Type of work: Homebased

Responsibility for markets: Germany/ Switzerland/ Austria

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

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 Germany/ Switzerland/ Austria
Preparation, translations from English of local Product Labelling (e.g. SmPC, PIL), in German language for Germany/ Switzerland/ Austria
Artwork and promotional materials review and approval in client systems
Manage multiple 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 of EU requirements for medicinal products including the creation of regulatory submission documents and coordinating delivery to submission plans, artwork review, communication with the Health Authority, in country-specific experience (Germany/ Switzerland/ Austria) would be benefit, but not required
Experience with working in a large regulatory organization where some tasks are managed centrally and some at a local level
Knowledge of local (Germany/ Switzerland/ Austria) pharmaceutical legislation, relevant guidelines and requirements would be a plus
excellent organization and communication skills,
ability to work to tight timelines
Good team player
Excellent written and verbal communication skills in English and German
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

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