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Regulatory Affairs Manager (m/f)

Regulatory affairs comprise a multitude of tasks that require expert knowledge and continuous information update and training. Besides national marketing authorizations, new authorizations can meanwhile only be acquired through the mutual recognition procedure (MRP) or the EU centralized procedure.  While these procedures address European requirements, knowledge about the respective national authorization procedures is required to fulfill country-specific requirements for all countries outside Europe (in particular, USA and Japan). The Regulatory Affairs Manager (m/f) serves as internal contact and is also responsible for relations with the regulatory authorities in the respective countries.

He/she is also involved in negotiations with various licensing partners. In companies where research & development of new drugs are only partly or not conducted within the company, development projects must be in-licensed when they reach a certain development stage or when development is completed.

Increasing regulatory requirements – for instance, the new requirements of the EU Clinical Trials Directive that must be incorporated in national law, the structural changes for the application according to the Common Technical Document (CTD) or, in the future, eCTD – require continuous education. The Regulatory Affairs Manager (m/f) must also deal with legal issues and ensure that deadlines for marketing authorizations, renewals or responses to complaints are met.

Also, preciseness and responsibility as well as great diligence and self-organizational skills are required for this work. Pharmacists and also chemists and biologists are qualified for regulatory affairs positions.

Interest in rules and regulations, norms and legal texts as well as their interpretation and application are also key for such positions. In the face of increasing internationalization, foreign language skills, in particular, English knowledge, are extremely important.

While a doctoral degree may be helpful, it is not a mandatory requirement for this position.