Quality & Safety
Secondment via YER
Food, Feed, Pharma
Over deze vacature
Did you always want to work in a company where your work can have a real impact? Do you enjoy working in an international environment with lots of room for personal development?
As Senior Specialist you will be working in one of the RA product managers teams of Global Regulatory Affairs Biological. You will be involved in supporting the new licensing activities of several major new product ranges and the regulatory maintenance of existing biological products.
Global Regulatory Affairs - Biological provides you a challenging environment where you will get the opportunity to broaden your skills as regulatory affairs professional or to develop into one.
- Providing state-of-the-art dossiers, variation and renewal packages for licensing of new Biological products and maintenance of the existing biological product portfolio;
- Providing 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;
- Developing regulatory strategies for new and existing biological products;
- Maintaining the biological portfolio in the marketplace by providing expert regulatory advice to stakeholders within and outside the company;
- Developing and maintaining contacts with regulatory authorities;
- Participating in regulatory expert groups within the veterinary pharmaceutical industry association(s) to play a role in the development of future veterinary legislation and guidelines;
- 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.
This company is one of the world's best in research, development and production of vaccines and medicines for animals.
You will be employed by YER and seconded to our client, we offer:
- Good employee benefits (eg work-life balance, pension, lease car, bonus model)
- Challenging assignments
- Excellent guidance from your adviser and the YER back office
- Development opportunities, including the YER Talent Development Program with a personal coach
- Intensive guidance of international candidates (including Dutch lessons, tax return and housing assistance)
- Cooperative and result and relationship driven
- Friendly atmosphere and open culture
- Community/network with other technology professionals from different multinationals
- Events and masterclasses with interesting speakers and appealing companies
- Academic education followed preferably by Ph.D. (or equivalent experience) in biomedical sciences (e.g. virology, bacteriology, molecular biology, veterinary sciences);
- 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 biological is an asset.
- 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.