Regulatory Submission Manager

Exalon GmbH

Radolfzell am Bodensee

EUR 40.000 - 60.000

Jobbeschreibung

Exalon GmbH is a growing company based in Radolfzell at the Lake of Constance. As service
provider specialized in electronic regulatory submissions we work with international customers from
pharma and biotech industry as well as drug manufacturers. To expand our publishing group we are
looking for a

Regulatory Submission Manager
(eCTD Publishing)

Responsibilities:
• Management of regulatory submission projects for various clients and regulatory procedures

Publishing of regulatory submissions in eCTD (electronic Common Technical Document) format

for regions such as EU, CH, US, CA, AU

Awareness/monitoring of the applicable regulatory guidelines and internal procedures
Involvement in various quality control processes, incl. SOP authoring
Formatting of Word documents and processing of PDF documents

Qualifications / Skills:
• Degree in regulatory affairs, medical documentation or comparable technical / pharmaceutical

qualification

Experience with regulatory eCTD publishing and knowledge of regulatory affairs requirements,

working experience with docuBridge (Lorenz) would be a plus

Experience with Document Management Systems
Proficiency with IT systems, especially MS Office programs (Word, Excel) and Adobe Acrobat
Detail-oriented with the ability to check documents for accuracy as well as consistency
Good communication skills (both oral and written - English / German)

Offer:
• You will be part of a dynamic team involved to various interesting / international projects

Opportunity for professional development and increasing responsibility
Detailed training regarding systems and processes
Home office possible, onsite presence for initial phase (depending on experience)

Contact:
• Sibylle Teuchmann, Tel. 07732/939-1652, Email: info@exalon.com

Please send your application electronically (including potential start date and salary requirement)

Exalon GmbH, Fritz-Reichle-Ring 2, 78315 Radolfzell, Germany
Phone: +49(0)7732-939-1650, Fax: +49(0)7732-939-1655, Email: info@exalon.com