Regulatory Affairs Manager Clinical Trials (f/m)

For almost 10 years Progressive has been partnering with Life Science companies and senior talent in the German market to deliver market-leading recruitment services.

By focusing on exceptional service levels and building a business that puts specialisation at the heart of everything we do, we have built a reputation based on delivering local expertise, knowledge and solutions no matter where in the world you are.

InSouthern Germanywe are looking for a

Senior Regulatory Affairs Manager (f/m)

Your tasks:

* Perform central and local IRB/IEC and Competent Authority submissions according different National Drug Laws
* Prepare and/or do a Quality Check of Clinical Trial Application forms (CTA, XML).
* Receive and process study documentation from the sites, assessing accuracy and completeness
* Attend internal and external study meetings and provide regulatory status reports

* Perform and compile all required documentations for submission to IRB/IEC (central and local) and to the Competent Authority
* Submissions to IRB/IEC and/or Competent Authority
(First submission, Substantial Amendments (Protocol-related and for notification only), Notification of additional Sub-Investigator's, Shipment of Annual Safety Reports, revised IB's and IMPD's
* Assessing accuracy and completeness of the Regulatory-Package for drug release

Your profile:

* German (mother tongue preferred) and good English language skills (mandatory, other languages are always welcomed)
* Academic background (biology, chemistry, biochemistry, pharmacy, medicine, ecotrophology etc.)
* 5+ years in regulatory affairs
* Preferably clinical operations experience (CRA and/or PM for 2+ years)

The company offers excellent training as well as personal and career development opportunities in this expanding company. Furthermore, careful selection of employees has ensured an open, friendly and fun working environment and the company enjoys a very low staff turnover rate.

Are you interested?

Do not hesitate to contact me, Coralie Krumpholtz 0n 089 5519766 or send over your CV.