RA Officer

Aufgabenbeschreibung

Regulatory Affairs Officer

Role: Full-time, permanent

Location: Salzburg, Austria

Die Rolle

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 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.

Die Person

• Responsible for local repackaging (artwork, agreements etc.)
• Liaise with Ages for national phase submissions and follow up for grant for marketing authorization in AT
• Liaise with Ages for national phase of variations (where needed)
• Artwork approval for submissions to AGES and also for release to manufacturing sites
• Reimbursement price applications in AT and follow up of the price approval procedure
• Maintenance of granted Austrian marketing authorizations including communication regarding marketing status and sunset provision
• Liaise with AGES for national approval of educational material and distribution plan
• Product list: Inserting RA relevant data for new products and maintenance of present products

Die Auszeichnungen

• Structured and scientific way of working, working with precision, reliability and integrity
• Good project planning skills paired with conscientious and results-oriented mind-set
• Bargaining power and assertive
• Team player and strong communication skills
• Self-motivated interest in high quality work
• Hands-on experience with AMG and HWG
• Basic product knowledge including medical expertise for medicinal products
• Desirable is 2 years’ experience in a pharmaceutical generic company, preferably as Officer and/ or Manager in the Regulatory Affairs Department
• 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)
• Excellent communication skills in German (native level) and English (business fluent)

Wie man sich bewirbt

In return, we offer a competitive salary and rewards package. 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.

Etwas über uns

If you have the experience, passion and ability to make this role a success then we would love to hear from you. Please complete your Candidate Profile on our careers site to apply for this role. The closing date is 17/08/2024. For more information, you can contact us on: careers@accord-healthcare.com

Fußzeile

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.