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2 april 2020 12:00:25

 
Director Regulatory Affairs / Licensing (Global) (Thema Group)
 


Key assignment:  As Director RA/Licensing 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 •    Manage the licensing team of GRA Biologicals by ensuring proper resource allocation and priority setting for the team (12 to 15 staff) in line with overall business priorities; •    Ensure timely submission and appropriate follow-up of new product applications as well as regulatory maintenance of previously authorized products including variations, renewal applications and supplemental marketing authorizations; •    Keep oversight of European and International licensing activities for new and existing products in alignment with the company`s strategy and objectives; •    Function as the key regulatory interface for the Country Regulatory Affairs representatives (CORAs), regional RA coordinators, regional management, manufacturing and other company departments, as relevant. •    Develop regulatory submission strategies with (internal) stakeholders to ensure optimal new product licensing and regulatory product maintenance in view of costs, resources and time to market in designated countries; •    Pursue developments of regulatory legislation and requirements with a focus on licensing aspects.  Identify new and emerging requirements, evaluate their potential impact on licensing aspects and regulatory (submission) strategies for the Biologicals product portfolio and communicate them to relevant departments. •    Monitor the regulatory compliance status in the countries concerned; •    Ensures that regular trainings are provided to other functions e.g. CORAs on relevant GRA procedures and systems; •    Participate in industry association committees and initiatives as regulatory expert to represent and defend the company`s interest e.g. Animal Health Europe. •    Ensure that all direct reports have clear objectives and personal development plans


 
100 viewsCategorie: Wetenschap
 
 

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