Your new role
You will be working in the licensing team of Global Regulatory Affairs Biologicals. The Licensing team is responsible for all licensing aspects of regulatory submissions. The focus of your activities will be the licensing aspects of the required regulatory submissions. In addition, you will provide support for the licensing activities of new products and the regulatory maintenance of existing biological products. Your responsibilities will include but won’t be limited to: Direct interaction with authorities to discuss licensing aspects of regulatory submissions. Act as first point of contact within GRA for CORAs and Authorities and as intermediate between RA product managers and CORA and/or Authorities; Send out dossiers/variation packages to the CORAs and/or competent authorities and ensure timely follow up; Initiate and conduct all standard licensing procedures and, with support, complex licensing procedures. Provide guidance for standard licensing procedures to less experienced staff; Develop regulatory strategies to cope with future requirements and minimize business impact.
What you'll need to succeed
Your new company
- 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. Ability to initiate improvement of more complex processes;
- Full proficiency with information systems;
- Ability to train colleagues on the job.
MSD is a leading company in global biopharmaceuticals with a diverse portfolio of prescription medicines, oncology, vaccines and animal health products. With 69,000 employees operating in more than 140 countries, MSD offers state-of-the-art laboratories, plants and offices that are designed to inspire their employees as we learn, develop and grow.
The department Animal Health is located at the Boxmeer site. There they develop new medicines specifically for animals. They produce, amongst others, vaccines that prevent bacterial, parasitic and viral infections at both pet as farm animals. MSD is one of the first companies that focuses on biological research for animal health.
What you'll get in return
Hays Detachering | This is a project that will start with a contract of one year through Hays. Extension to stay within the department is anticipated. At this position, you will get a competitive salary (€4,500- €6,850) and your travel expenses are covered.
What you need to do now
If you are interested in this role as Senior Regulatory Affairs Specialist, click ‘Apply now’ to send an up-to-date CV, or give us a call! Is this job isn’t quite right for you, but are you still looking for a new position? Please contact us for a confidential discussion on your career.