What are the tasks and responsibilities of regulatory affairs managers?
By making an important contribution to the development, production and licensing of products and ensuring their compliance with the requirements of regulatory authorities, regulatory affairs managers promote chemical and pharmaceutical innovations. Furthermore, they prepare comprehensive documentations of products, including product information for packaging and package inserts, required for the approval for market entry by the authorities.
Regulatory affairs managers are important in marketing as well since they ensure the appropriate advertising of cosmetics, drugs and chemical products. Last but not least, they are the point of contact for authorities and the press in critical situations, e.g. in case of unforeseen adverse reactions.
- Providing advice and support during the conceptual and development phase
- Ensuring the compliance of new products with regulatory requirements
- Preparation of comprehensive documentations of complete product development processes
- Providing advice to the marketing department
- Communication with regulatory authorities
- Crisis communication in case of adverse reactions