The regulatory function is critical throughout the entire lifecycle of a pharmaceutical product – from initial development to product discontinuation.
In Novo Nordisk, regulatory employees play a key role in our business, as ensuring a robust strategy for obtaining and maintaining regulatory licenses often has a significant impact on our bottom line.
Our regulatory professionals and regulatory leads collaborate across functions and with project teams to establish a compelling storyline for negotiations with health authorities when it comes to the approval of new marketing authorisations and amendments to existing licenses.
These individuals must therefore be able to understand the technical details of a product and be able to view that information in the context of the wider product profile and the needs of patients.
Based on sound scientific argumentation and specific regulatory requirements stipulated by authorities, regulatory professionals and leads define the content of regulatory dossiers. This content is discussed and negotiated with authorities when required.
Regulatory professionals and leads also develop submission strategies with pharmacovigilance, manufacturing and medical advisers, and they negotiate approval terms for applications with authorities. Because they have broad stakeholder contact within and outside the organisation, strong collaboration and communication skills are essential.
Our regulatory colleagues are often educated as pharmacists or engineers, sometimes specialised within chemistry or biotechnology. Certain regulatory professionals might also come with experience from related fields such as manufacturing, although others typically have medical or clinical backgrounds.
Senior regulatory professionals generally have 4-5 years of relevant experience, while a specialist or lead usually has at least seven years of regulatory experience as well as supplementary experience from other pharmaceutical disciplines.