Join to apply for the Regulatory Affairs Manager role at Accord Healthcare
Role: Fixed Term Contract, 24 months – full time hours
Salary: Competitive + bonus + benefits
The Role
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.
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 authorisations 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 harmonised preparation and release of common artwork.
The 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, characterised 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).
In return
We offer a competitive salary and rewards package (including holiday, bonus and pension scheme). This role offers the opportunity to genuinely make a difference within a progressive and expanding business during a period of growing international reach.
How to apply
Complete your Candidate Profile on our careers site to apply for this role. The closing date is 25 November 2025. For more information, contact us at careers@accord-healthcare.
About Accord Healthcare
Accord Healthcare Europe is one of the fastest growing pharmaceutical companies in Europe. With a large market footprint in over 80 countries, we deliver vital, affordable medicines to national health systems and transform patient lives worldwide. Our approach is agile and inventive, always seeking to improve products and patients’ access.
Seniority level: Mid‑Senior level
Employment type: Full‑time
Job function: Quality Assurance
Industries: Pharmaceutical Manufacturing and Biotechnology Research
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