Supports the regulatory submission creation and the registration tracking of the company regulatory submission targets from a regulatory operational perspective for the whole region.
Manage Operations aspects of submission planning for assigned products
· submission planning,
· document retrieval,
· submission creation and
· delivery to Health Authorities
· Bachelor’s degree in a Life Science related discipline
· High level expertise and knowledge of the regulatory landscape, its registration procedures and a thorough understanding of the technical requirements for dossiers (e.g. eCTD and other submission formats)
· At least 2 years’ experience in the regulatory operations area, regulatory affairs will be an asset
· Able to multitask with proven project management capabilities including managing dynamic timelines, interacting and negotiating with others, collaboration skill and excellent follow-up ability
· Excellent communication skills to manage interactions with colleagues within and outside the department to co-ordinate the regulatory submission for a timely delivery
· Capability to keep overview in the complexity of planning, managing, tracking, assembling and delivering of regulatory content, to meet regulatory strategy, regulatory compliance and informational needs for internal and external customers.
· Ability to handle time pressure and the consequence of any delay in timely submissions
· Affinity to work with complex IT systems