You will become part of a project team involved in updating the product information for all biological products licensed within the European Union as required by the New Veterinary Regulation. The focus of your activities will be the content 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.
To facilitate the introduction of a new product, a new building, clean rooms, utilities, and multiple new production equipments are being established and associated qualification and product validations are needed. Senior Qualification/Validation Experts to support activities are required.
Because of the location this role is partly remote, requiring travel roughly once a month where accommodation will be arranged.
Your activities would include:
- Prepares and manages timely submission of high-quality state of the art scientific dossiers for efficient licensing of new products and maintenance of existing products (i.e., variations, renewals);
- Prepares and manages timely submission of high-quality answers to questions from regulatory authorities during licensing procedures;
- Participates in visits to authorities to discuss regulatory and technical aspects for new submissions and answering of questions during licensing procedures;
- Develops and maintains profound knowledge of all relevant regulatory requirements;
- Supports the development of regulatory strategies for new and existing biological products;
- Actively follows the development/emergence of new regulatory requirements, to support the assessment of their potential impact for new product development and product maintenance and to develop regulatory strategies to cope with future requirements;
- Participates with support of the team lead in multidisciplinary product development and maintenance teams to provide veterinary regulatory expertise
Modis is part of the Adecco Group and is in the business of consultancy and professional staffing. We currently employ 500 consultants in the Netherlands and 20,000 worldwide.
The focus of Modis Life Sciences is mainly in the direction of QA, QC, PV, RA, R&D and process engineering profiles within an organization in the fields of Biotech, Food and the Pharmaceutical industry. We have Consultants working at the EMA, Janssen, Sanquin, Astellas, Unilever, Corbion, MSD, Aspen and many more!
We have an exciting new job opportunity as an RA Product Manager at MSD Animal Health at their location in Boxmeer.
Global Regulatory Affairs (GRA) is accountable for licensing and maintaining pharmaceutical and biological animal health products globally. GRA Biologicals is a part of this department and responsible for the biological product portfolio.
You will be working in one of the RA product managers teams of Global Regulatory Affairs Biologicals. The RA product manager teams are responsible for the content of regulatory submissions.
Functie-eisen• Knowledge of or several years of experience in the (veterinary) pharmaceutical industry in the development and/or maintenance of products, and in regulatory affairs, preferably in the field of biologicals is an asset.
- Academic education followed preferably by Ph.D. (or equivalent experience) in biomedical sciences (e.g. virology, bacteriology, molecular biology, veterinary sciences);
- Excellent oral and written command of the English language; Excellent writing skills.
- Effective communicator and negotiator;
- Flexible and persistent personality. Service and compliance minded.
- Good team player skills;
- Ability to work under high pressure and to meet deadlines;
- Ability to work in a matrix and multi-cultural environment;
- Attention for details;
- Basic knowledge of project management.