Regulatory Affairs Graduate
Copenhagen Area, Capital Region, Denmark
September 2017 - April 2018: Copenhagen, DK (Novo Nordisk HQ)I spent 8 months working in the life cycle management (LCM) clinical department for modern and human insulins. My role included reviewing/submitting pharmacovigilance documents (RMP, PSURs, DSURs), completing affiliate requests for documentation, driving a project to create a document package supporting the innovator status of a line of our modern insulin products to support colleagues in countries where guidelines defining originator/reference/innovator and biosimilar products are either lacking or unclear, & driving a labelling alignment project.May 2018 - December 2018: Dubai, UAE (Regional office)I was positioned in the Regional AAMEO (Africa, Asia, Middle East, and Oceania) Regulatory Affairs department. Alongside the senior RA manager, we were both responsible for 110 countries, driving operational and strategic projects across the entire region. These included:- Evaluation and optimisation of the current RA operating model- Implementation of strategic plans to improve various RA processes- Mapping of biosimilar guidelines, or the lack thereof, across the region in aid of plans for advocacy.- Working on cross-functional projects with stakeholders from marketing, market access and medical affairs.- Planning and rolling out workshops with affiliates and business areas.- Collecting affiliate RA-specific performance data in collaboration with an external organisation, and creating new data output for the organisation.January 2019 - September 2019: Copenhagen, DK (HQ)I then spent the final 8 months in the Regulatory Affairs Chemistry, Manufacturing and Control department for biopharmaceutical products, specifically working on LCM for NovoEight. Some of the tasks included assessing global regulatory impact of changes to various manufacturing processes, distributing NDA dossiers to follow-on countries, & compiling and submitting Type 1B and Type 2 variations to EMA.