Regulink were asked to provide interim 0.5 FTE support to a pharma client, due to staff shortage at its UK & IE affiliate. Regulink was well placed to provide the necessary market experience and seamlessly onboard into the client role whilst the client recruited a replacement permanent affiliate lead.
The client had a challenge absorbing the workload of this busy department into its other affiliates and hence reached out to Regulink to provide the urgent support needed.
Activities were typical of a national regulatory affiliate and highly varied in nature.
The functional support involved new MAAs, post-approval activities such as variations & artwork submissions, unlicensed medicines and importation advice, provision of local intelligence to the organisation, supply issue handling, representation in internal and external meetings and very close interaction and liaison with the national authorities, MHRA and HPRA.
The support also requested assistance with onboarding the new incumbent to their role and projects before transitioning off.
