Regulatory Affairs Manager

Aufgabenbeschreibung

Regulatory Affairs Manager

Role: Fixed Term Contract 24 mths -full time hours

Location: Salzburg, Austria

Salary: Competitive + bonus + benefits

Die Rolle

The Regulatory Affairs Manager is responsible for ensuring compliance with the prohibition contained in respective Austrian laws and for ensuring that the labelling, the package leaflets, the expert information and advertisements correspond with the content of the marketing authorisation or registration.

Your key responsibilities:

• Preparation of national text and ensure alignment of national product information with the current QRD template and Austrian regulatory requirements.
• Liaise with AGES during the national phase of marketing authorization applications and follow up to secure approvals.
• Management of variations and Coordinate with AGES for the national phase of variation procedures, as required.
• Request and manage EAN/PZN numbers to support artwork preparation.
• Oversee artwork approval for regulatory submissions to AGES and for release to manufacturing sites.
• Submit and monitor reimbursement price applications in Austria, including follow-up on approval procedures.
• Manage Austrian marketing authorizations post-approval, including updates on marketing status and compliance with sunset clause provisions.
• Coordinate with AGES for national approval of educational materials and associated distribution plans.
• Enter and maintain regulatory affairs data for new and existing products in the product database.
• Draft, update, and maintain local Standard Operating Procedures (SOPs) relevant to regulatory affairs.
• Collaborate with the Information Officer, Global Regulatory Affairs team, and Artwork team to ensure timely artwork approval and release to manufacturing.
• Work closely with the Regulatory Affairs team in Germany to ensure harmonized preparation and release of common artwork.

Die Person

• Knowledge of the Austrian Guideline for the Naming of Medicinal Products
• B.Sc., Master’s degree, or equivalent in science, pharmacy, or medical studies (pharmacist)
• Demonstrable experience in a pharmaceutical company, preferably in a Regulatory Affairs role at Officer or Manager level.
• Practical experience with AMG) and HWG.
• Solid foundational knowledge of pharmaceutical products, including a basic medical understanding of medicinal products- experience with biosimilar products is an asset.
• A structured and scientific approach to work, characterized by precision, reliability, and integrity.
• Strong project planning capabilities, combined with a conscientious and results-driven mindset.
• Demonstrates bargaining power and assertiveness in professional interactions.
• Effective team player with excellent communication skills.
• Self-motivated with a strong commitment to delivering high-quality work
• Excellent communication skills in German (native level) and English (business fluent)

Die Auszeichnungen

In return, we offer a competitive salary and rewards package (including holiday, bonus and pension scheme). Not to mention the opportunity to genuinely make a difference in a new and dynamic role within a progressive and expanding business, at an exciting time of growing international reach. 

Wie man sich bewirbt

If you possess the experience, passion and ability to make this role a success then we would like to hear from you. Please complete your Candidate Profile on our careers site to apply for this role. The closing date is 28/08/25. For more information, you can contact us on: careers@accord-healthcare.com

Etwas über uns

Accord Healthcare Europe is one of the fastest growing pharmaceutical companies in Europe. Accord has one of the largest market footprints of any European generic and biosimilars companies selling generic medicines in over 80 countries around the world. This global footprint enables us to deliver vital, affordable medicines to national health systems supporting healthcare professionals to transform patient lives worldwide. The approach of Accord is agile and inventive, always seeking to improve products and patients' access to them. Accord are driven to think differently and deliver more for the benefit of patients worldwide. 

To continue our growth, we’re looking for the best and brightest technical minds and forward-thinking business professionals. Keeping our people at the heart of all we do, we offer rewarding opportunities for those looking for continued personal and professional growth, investing in training and development tailored to each individual’s focus. So, if you’re looking for an inclusive company to take your career to the next level, you’re certainly in the right place; come and join us to make it better.

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