Title:  RA Officer

Role Details

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 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.

The 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

The Rewards

• 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)

How to Apply

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.

A Bit About Us

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

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All applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or disability.

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