Regulatory & Medical Affairs

Regulatory Affairs

Proprietary medicinal products are authorized on the basis of the Medicines Act by the BfArM (Bundesinstitut für Arzneimittel und Medizinprodukte - Federal Institute for Drugs and Medical Devices). The quality, effectivity and innocuousness of the medicinal product is examined. Since 1978, all proprietary medicinal products need to be approved by an appropriate authority. The EMEA is responsible for the approval in Europe, whereas the FDA is responsible for the approval in the US.

As part of the approval procedure, the manufacturer's documents will be examined by the authorities, which should verify the quality, efficacy and innocuousness. In the course of this, it is examined whether the manufacturing, quality control and testing in the corresponding studies (preclinical and clinical), are in accordance to the given guidelines.

Not only the valid pharmaceutical policies have to be considered, but also the current guidelines and the state of scientific knowledge. For this, among other things, the results of the pivotal studies (clinical trials phase III), are systematically evaluated.

Required qualifications

• In general academic degree
• Prevalently doctors or pharmacists, as well as biologists, chemists, veterinarians with according experience or an additional qualification

Job profiles (examples)

• Regulatory Affairs Manager
• Regulatory Dossier Writer (Modules 1-5)
• Regulatory Writer
• Technical Writer
• CE Certification
• Expert EMEA
• Expert FDA
• Expert REACH (Registration, Evaluation, Authorization and Restriction of Chemicals)

Medical Affairs

The sector Medical Affairs is originally a subsidiary of marketing. It deals with the marketing of pharmaceutical products, by generating new insights and knowledge of already approved and marketed pharmaceuticals.

Depending on the organization of a company, this field is generally classified as part of medicine or marketing.

Required qualifications

• In general academic degree
• Prevalently doctors or pharmacists, as well as biologists, chemists, veterinarians

Job profiles (examples)

• Medical Affairs Manager
• Medical Liaison Manager
• Medical Scientific Manager
• Medical Advisor
• Medical Writer
• KOL Management