(Senior) Regulatory Affairs Manager (m/w/d) Regulatory Operations

YOUR CHALLENGE

Join our motivated team in Global Regulatory Affairs and grow with exciting challenges. As (Senior) Regulatory Affairs Manager you will strengthen our Regulatory Operations Team, which supports our regulatory processes and continuously improves them to ensure their long-term success. This includes, for example, the following tasks:

• Support of our electronic document management system (eDMS), in particular with regard to further development of the system, interfaces as well as training and support.

• Compiling and managing dossier submissions, also in coordination with partner companies

• Ensuring compliance with legal and internal requirements in the context of Computerised System Validation (CSV)

• Assumption of project management activities in support of IT projects

• Controlling our process and quality management by creating and updating SOPs/WIs and conducting internal training measures

YOUR PROFILE

• Degree or training with sound professional experience in the IT sector, focus on systems engineering or comparable qualifications

• Experience with electronic document management systems (eDMS)

• Business fluent English

• Knowledge of IT systems in the area of regulatory operations desirable

• Analytical thinking and problem-solving skills

• High degree of reliability and ability to work in a team

YOUR BENEFITS

• Permanent employment with long-term career opportunities

• Flexible working time model that allows for a good work-life balance

• Attractive location with good transport links and modern, well-equipped workplaces

• Global family business with flat hierarchies and short decision-making processes

• Cooperation in multifunctional, international teams

• Attractive remuneration with extensive social benefits

Find out more about our offer here.

ABOUT US

Merz Therapeutics GmbH is headquartered in Frankfurt am Main, Germany, and is represented in more than 90 countries worldwide. As part of the Merz Group, a privately held, family-owned company, we have been dedicated to the development of innovations for more
than 110 years.

Merz Therapeutics is committed to improving treatment outcomes for patients around the world. With our relentless research & development efforts and culture of innovation, we strive to identify unmet patient needs and provide appropriate treatments. In particular, we focus on
patients suffering from movement disorders, neurological diseases, liver diseases and other health issues that severely impact quality of life. For more information, visit  https://www.merztherapeutics.com/.