CROMA-PHARMA is an internationally active, family-owned pharmaceutical Company with its headquarter in Leobendorf, Korneuburg district, in the north of Vienna. Many years of experience in the manufacturing of products based on hyaluronic acid and a unique level of expertise in the field of aesthetic medicine have made CROMA-PHARMA a globally renowned specialist in the dynamic and versatile business of anti-aging.
Regulatory labelling is the department in CROMA responsible for the administration, translation and publication of product related labels such as instructions for use and folding box texts. Our product portfolio comprises cosmetic products, medical devices and drug products distributed in more than 60 countries of the world. Regulatory labelling plays the key role in the life cycle of our product texts and acts as central coordination unit between translation offices and internal departments.
We are searching for applicants who want to make a sustainable contribution to our success as a family- run Austrian company.
We are expanding our Regulatory Development department and therefore looking for a/an Regulatory Labelling Manager.
- Editing of texts for medical devices, cosmetics and drugs
- Coordination of translations and proof reading of texts
- Labelling project management from conception, creation to print
- Documentation and archiving according to the QM system
- Support in the regulatory approval and registration process
- Support the labelling department in analyzing and reporting of labelling standards, guidelines according to the internal regulatory surveillance process
- Degree in translation studies or those with a comparable level of education or qualification
- Basic knowledge of Adobe InDesign is essential
- Fluent in English and German (oral and written)
- Additional language knowledge advantageous
- Well organized and ability to achieve results within short timelines both independently and within a team
- Work experience desirable but not required
- Knowledge of regulatory labelling standards and guidelines (ISO 15223, ISO 20417, EU 2017/745, FDA/CFR, EMA, EC 1223/2009) desirable
We offer a varied work in a rapidly expanding company with diverse development opportunities and company benefits, as well as flexible working hours and home office. If you want to become part of a dynamic team, we look forward to meeting you!
For this position, a salary of EUR 39.625,32 (full-time, 38h) applies gross p. a. Willingness to overpayment exists and depends on the specific qualification and experience.