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.