Lotte Froberg Balle

Regulatory Affairs Officer

Lotte has more than 10 years of experience within regulatory affairs – both development and maintenance regulatory affairs. Within development RA, Lotte has been responsible for CTA submissions and supported project teams towards other authority submissions such as IND, PIP and Orphan Drug Designations. Further she has experience with EU SME applications and set-up/maintenance of Compassionate Use/Named Patient programs in Europe.

Within maintenance RA, Lotte has assessed CMC change requests and prepared global variations packages. As part of her work for pharma headquarters, she has been responsible for communication with subsidiaries related to local submissions and renewal applications.