Attractive salary and fringe benefits
Detachering via YER
Medical & Health
Over deze vacature
The Associate Specialist Licensing is a member of the Licensing Team of Global RA Biologicals.
The Licensing team has the responsibility to manage and keep full oversight of all licensing activities for Biological products worldwide, except in US. The Licensing Team supports -and executes in EU- all licensing activities in the dedicated countries through interface with Country Operation Regulatory Affairs in all countries and the competent authorities in EU. The licensing team is responsible for the submission strategy for the licensing of new products and regulatory maintenance of existing products (e.g. variations, renewals).
- Act as first point of contact within GRA for CORA (representatives) of designated countries;
- Maintain good working relation with the contacts:
- Within GRA (Product Managers, Operations, Pharmacovigilance);
- Within MSD AH (CORAs, MMD) – local and international;
- Outside MSD (3rd party CORAs, Dutch Ministry).
- Arrange required documents, data, samples, test materials and all other items necessary in support of obtaining and maintaining marketing authorizations. Ensure timely availability of the requested documents and materials, in line with the licensing strategy;
- Act as intermediate between GRA Product Managers and CORA;
- Communicate new, amended and renewed marketing authorizations to all stakeholders, plus enter and check these data in(to) the GRA information systems;
- When receiving questions from the various authorities through the CORA, compile answers, where necessary with support of colleagues within GRA or from other disciplines;
- Communicate internally the changes in registration requirements of the designated countries;
- Use existing procedures to solve routine or standard (licensing) problems; apply limited judgment and discretion;
- Participate in determining registration strategies for the designated countries;
- Send out dossiers/variation packages to the CORA and/or competent authorities and ensure timely follow up;
- Support fulfillment of any regulatory commitment given during a registration procedure;
- Timely manage all actions necessary for obtaining new or amended translations for centrally authorized products via CORA. Communicate with CORA and the European Medicines Agency on translation activities.
Global RA Biologicals is part of Global Regulatory Affairs Animal Health. Global RA Biologicals is responsible for licensing of new biologicals and the regulatory maintenance of licensed biologicals world-wide except US.
- Attractive salary and fringe benefits
- Bachelor or equivalent in preferably Veterinary, (Bio) Chemistry, Biology, or Bio-Medical area, if not a Higher Professional education, then proven skills and experience to work on such level;
- Fluent English (speaking, reading and writing);
- Accurate, efficient, pragmatic, flexible, service- and compliance minded and able to work under (time) pressure;
- Well-developed cultural awareness;
- Excellent communication skills; communicates information, asks questions and checks for understanding;
- Basic conceptual knowledge of country-specific requirements and/or EU licensing requirements;
- Applies general knowledge and understanding of general aspects of product development, production and quality control;
- Ability to gain basic understanding of internal processes;
- Full proficiency with information systems.