Director Regulatory Affairs Poultry (Global) (Thema Group)

Key assignment:  As Director Regulatory Affairs Poultry you will be responsible for a team of professionals that plays a key-role in the licensing of new biological products and the regulatory maintenance of the existing Biological product portfolio globally (except for the United States). Responsibilities •    Manages the RA product manager team with respect to resource allocation, budget, workload for individual staff (3 to 5 staff), performance, and priority setting for the team in line with overall business priorities; •    Ensures that all direct reports have clear priorities and personal development plans; •    Ensures the timely submission of high-quality dossiers and answers to questions for efficient licensing of new products and maintenance of existing products  (i.e. variations, renewals) in close cooperation with the project teams as well as other regulatory groups (licensing, dossier building, artwork management); •    Keeps oversight of the status of new development and life cycle management projects of the RA product managers team including required GRA resources; •    Takes an active role in setting up efficient roll out strategy for (new) products in the various markets, provides regulatory input on portfolio rationalization strategy and contribute to Value Chain activities; •    Communicates effectively with stakeholders to ensure that GRA timelines and activities meet business expectations •    Develops and maintains profound knowledge of all relevant regulatory requirements and takes the lead in the development of regulatory strategies for new and existing biological products in view of costs, resources, time-to market while considering the changing regulatory environment, the company`s objectives and the business plans of all stakeholders; •    Develops and maintains contacts with regulatory authorities and visits authorities to discuss regulatory and technical aspects of licensing procedures; •    Participates directly in a limited number of multidisciplinary product development and maintenance teams to provide regulatory expertise ; •    Ensures regulatory compliance by setting the appropriate standards for RA product managers and escalation of appropriate issues to higher management; •    Takes the lead or participates in general GRA projects including e.g. documentation system or regulatory database or GRA activities affecting large groups of products (complex variations/line extensions); •    Plays a pivotal role in the development of future veterinary legislation by providing feedback on future regulations, monographs and guidelines and representing GRA at international organizations and meetings (with authorities); •    Provides training and support to other (junior) staff and other relevant departments.