Regulatory Affairs Officer
Role: Full-time, permanent
Location: Salzburg, Austria
The Role:
We’re seeking an ambitious and knowledgeable Regulatory Affairs Officer to join our team in Salzburg, Austria. You’ll be responsible for ensuring compliance with Austrian laws and for ensuring that labelling, package leaflets, expert information, and advertisements conform with the marketing authorisation or registration.
Main Tasks Include:
* Repackaging (artwork, agreements, etc.) in the local market
* Liaising with AGES for national phase submissions and follow-up for marketing authorisation in Austria
* Managing variations with AGES where needed
* Approving artwork for submissions to AGES and for release to manufacturing sites
* Handling reimbursement price applications and follow-up in Austria
* Maintaining granted Austrian marketing authorisations, including communication about marketing status and sunset provisions
* Coordinating with AGES on educational material approval and distribution plans
* Updating product lists with RA relevant data for new and existing products
The Person:
* Structured, precise, reliable, and with integrity in work
* Good project planning skills with a results-oriented mindset
* Assertive with bargaining skills
* Strong team player with excellent communication skills
* Self-motivated and committed to high-quality work
* Hands-on experience with AMG and HWG regulations
* Basic product knowledge and medical expertise in medicinal products
* Desirable: 2 years’ experience in a pharmaceutical generic company, preferably as Officer or Manager in Regulatory Affairs
* Knowledge of Austrian guidelines for medicinal product naming
* Degree: B.Sc., Master’s, or equivalent in science, pharmacy, or medical studies (including pharmacists)
* Fluent in German (native) and English (business level)
The Rewards:
We offer a competitive salary and benefits package, along with the opportunity to make a meaningful impact in a dynamic and expanding business during an exciting phase of international growth.
How to Apply:
If you meet the requirements and are passionate about this role, please complete your candidate profile on our careers site. The application deadline is 17/08/2024. For more information, contact us at: careers@accord-healthcare.com
About Us:
Accord Healthcare Europe is one of Europe's fastest-growing pharmaceutical companies, with a presence in over 80 countries. We are committed to providing affordable medicines worldwide, supporting healthcare professionals and transforming patient lives. We value innovation, agility, and continuous improvement, investing in our people’s growth. Join us to advance your career in an inclusive environment focused on making a difference.
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