Max. € 60.000
Detachering via YER
Medical & Health
Over deze vacature
The Senior Specialist-Product Manager (SrSpclst-PM) is a member of one of the Product Manager teams within Global RA Biologicals. The product manager teams are responsibility for the licensing and regulatory maintenance of biologicals (new products and regulatory life cycle management). It has the overall responsibility for these activities for the products/projects within their responsibility. In addition, to the technical content of regulatory submissions, the teams are also responsible for the proper and timely involvement of other GRA teams/functions needed for these activities. Its members function as the main point-of-contact for MSD AH’s internal stakeholders (R&D, MMD, commercial) and will participate in meetings with external stakeholders such as competent authorities.
The SrSpclst-PM will participate in driving the new licensing and life cycle management activities from a RA point of view to assure efficient new licensing, product portfolio maintenance/improvement, and regulatory compliance, i.e. he/she:
- Provides state of the art dossiers, variation and renewal packages, and answers to list of questions, for licensing of new biological products and maintenance of the existing biological product portfolio;
- Provides veterinary regulatory expertise for new product development and product maintenance to ensure that relevant regulatory requirements are understood and followed by other relevant MSD AH departments;
- Supports the development of regulatory strategies for new and existing biological products, and to cope with future regulatory requirements;
- Supports the maintenance of the biological portfolio in the market place by providing expert regulatory advise to stakeholders within and outside the company;
The work of SrSpclst-PM has a substantial impact on the performance of the GRA department and the whole company in relation to licensing of new products and regulatory maintenance of existing product portfolio.
- Preparation and managing of timely submission of high quality scientific dossiers for efficient licensing of new products and maintenance of existing products (i.e. variations, renewals);
- Preparation and managing timely submission of high quality answers to questions from regulatory authorities during licensing procedures;
- Participation 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;
- Support the development of regulatory strategies for new and existing biological products;
- Actively following 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 of regulatory strategies to cope with future requirements;
- Participation with support of the team lead in multidisciplinary product development and maintenance teams to provide regulatory affairs expert know how to ensure new product development and product maintenance in line with relevant regulatory regulations, regulatory compliance;
- Support general GRA projects (e.g. Phoenix, Alexx, Symphony) or GRA activities affecting large groups of products (complex variations/line extensions for a group of products);
- Providing feedback on future regulations, monographs and guidelines;
- Providing training and support to other (junior) staff (content-related).
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 worldwide except US.
- Attractive salary and fringe benefits.
- Academic education followed preferably by Ph.D. (or equivalent experience) in biomedical sciences (e.g. virology, bacteriology, molecular biology, veterinary sciences);
- Profound knowledge of English speaking and excellent writing skills;
- Strong and effective communicator and negotiator;
- Flexible and persistent personality;
- Good team-player skills;
- Proven ability to work under high pressure and to meet deadlines;
- Knowledge of project management.