Senior Regulatory Affairs Licensing – HAYS – Nijmegen


Nijmegen | Regulatory Affairs | Licensing | Authorities | Submissions |EMA
Your new role
In this position you will be working in the licensing team of Global Regulatory Affairs Biologicals, which is accountable for all licensing aspects of regulatory submissions. You will be the first point of contact for country operation regulatory affairs and authorities. Your mains tasks will include sending out dossiers and variation packages to relevant authorities and ensure timely follow up. You will initiate, conduct and support all licensing procedures as well as interacting with authorities on licensing aspects and regulatory submissions. In this role you will managing all actions for obtaining new or amended translations for centrally authorized products via Country Operations Regulatory Affairs including communication with CORAs and EMA on these activities. In addition, you will discuss , amended and renewed marketing authorizations including commitments to all stakeholders, checks these data involving, when applicable, subject matter experts, and enter these data in(to) applicable information systems. Lastly, you will support the fulfilment of any regulatory commitment and assist the design of optimal submission strategies for licensing procedures.
What you’ll need to succeed
University degree or HBO Bachelor (or equivalent) in preferable Veterinary, (Bio) Chemistry, Biology or Bio-Medical area.
At least three to five years of experience in (veterinary) regulatory affairs, preferably in the field of biologicals.
Knowledge of or experience with the development and/or maintenance of products for the (veterinary) pharmaceutical industry is an asset.
Excellent oral and written command of the English language; Excellent writing skills.
Accurate, efficient, pragmatic, flexible, service- and compliance minded, able to work under (time) pressure, and well-developed cultural awareness.
Excellent communication skills, ability to interpret and explain (more complex) information and to lead others in straightforward situations.
Excellent team-player skills.
Ability to identify more complex (licensing) issues, analyze them, and provide possible solutions.
Ability to balance attention for detail with capacity to keep overview.
Developed conceptual knowledge and understanding of country-specific licensing requirements, and of general aspects of product development, production and quality control. Ability to apply this for more complex (licensing) issues.
Developed conceptual understanding of internal processes.
Full proficiency with information systems.
Your new company
Our client is driven by the purpose to develop and deliver innovative products that save and improve lives. With 69,000 employees operating in more than 140 countries, they offer state of the art laboratories, plants and offices that are designed to Inspire their employees as we learn, develop and grow in their careers Our client is a global biopharmaceutical leader with a diverse portfolio of prescription medicines, oncology, vaccines and animal health products. They are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. Our client encourages their employees to respectfully challenge one another’s thinking and approach problems collectively.
What you’ll get in return
Hays Detachering | This is a project that will start with a contract for 1 year through Hays. Extension to stay within the department is anticipated. At this position, you will get a competitive salary and your travel expenses are covered.
What you need to do now
If you’re interested in this role, click ‘apply now’ to forward an up-to-date copy of your CV, or call us now.
If this job isn’t quite right for you but you are looking for a new position, please contact us for a confidential discussion on your career. #1045109

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