Your new role
As a Senior RA Product Manager, you will be part of Global Regulatory Affairs - Biologicals team, that is responsible for the biological product portfolio. The RA Product Manager is accountable for the content of regulatory submissions, as well as, supporting in licensing activities and performing regulatory maintenance of existing biological products. Some main responsibilities include:
What you'll need to succeed
- Preparing and managing timely submission of high-quality scientific dossiers for efficient licensing of new products and maintenance of existing products (i.e., variations, renewals);
- Participating in visits to authorities to discuss regulatory and technical aspects for new submissions and answering of questions during licensing procedures;
- Developing and maintaining profound knowledge of all relevant regulatory requirements;
- Supporting the development of regulatory strategies for new and existing biological products;
In order to be a successful Senior RA Product Manager, you need to have a Ph.D. (or equivalent experience) in biomedical sciences. Additionally, you need several years of experience in the (veterinary) pharmaceutical industry in the development and/or maintenance of products. Based on your role, you need to be an effective communicator, have excellent writing skills and the ability to work with multiple teams. Fluency in oral and written English is mandatory.
Your new company
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 for 1 year through Hays. The project will last until 2026 (4 years), so renewal of contract is expected. Extension to stay within the department is anticipated. At this position, you will get a competitive salary (€4600 - €6800) 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 Ewa now
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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. #1045107