Assistance (M/F/d) Regulatory Affairs

vor 13 Stunden

Hamburg, Deutschland Alfred E. Tiefenbacher GmbH & Co. KG Vollzeit

As Assistance Regulatory Affairs you will work together with the Regulatory Affairs Manager on different regulatory issues to support our clients in the best possible way. You will work in an international environment with a focus on administration and preparation of chemical-pharmaceutical documentations.

A challenging task
Supporting the preparation of marketing authorisation documents.
Being involved in the preparation and implementation of EU-wide marketing authorisation procedures (MRP/DCP, CP) and variations.
Working together with the Regulatory Affairs Manager regarding the support of our customers in the submission of worldwide marketing authorisation procedures and variations.
Correspondence with customers and authorities.
Entering documents into our eCTD/document management system and maintaining data in the regulatory database.
Filing, archiving, electronic submission.

A convincing background
Education as a PTA, medical documentalist or a comparable qualification
Work experience in the pharmaceutical industry would be desirable
Strong communication skills and solution-oriented way of thinking, ability to deal confidently with people from different backgrounds and culture
Very good analytical skills, highest standards for the own work and the ability not to lose head or sense of humor even in hectic time
High degree of commitment, sense of responsibility and assertivenes
Very good German and English language skills as well as the confident handling of MS Office complete your profile

You are interested in our company and the position we can offer you?

The position will be filled by our HR Business Partner Marie-Theres Blumers.

We look forward to hearing from you

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