Responsible Regulatory Manager for Benelux
Location: BelgiumSIRE Life Sciences® is the market leader in life science recruitment. We believe the recruitment market needs to gear up in technology and continues innovation. We like technology, in a life science market driven on science, we couldn’t stay behind; we drive Recruitment Science. Investing a majority of our turnover in technology enables us to use unique Resource Technologies. By using highly advanced algorithms, we enable our team of Resource & Data Strategists© to maintain the most advanced, detailed and complete Life Sciences network in Europe. This big data enables us to work Reverse Recruitment©: we first analyze the market in-depth before we go out to the market. Because we analyze the whole market, we can compare facts and data. This enables us to do Facts & Big Data Recruitment©, making sure we, or better yet, you find the right career!
THE COMPANY
Our client is a professional Biotechnology and Pharmaceutical organization, based in Waals-Brabant Belgium.
The client is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products.
ROLE DESCRIPTION
In this role you will be responsible for all regulatory affairs activities within the Benelux region, including the interaction with governmental institutions and authorities to facilitate the clients products’ within the area.
RESPONSIBILITIES
- Responsible for coordinating the preparation, review and submission of regulatory dossiers in support of post-approval submissions
- Handle new product registrations in collaboration with the Regulatory Affairs Director
- Manage submissions and interactions with the regulatory bodies
- Ensure regulatory strategies are aligned with other teams and business objectives and deliverables.
- Maintenance of a sound scientific knowledge and expertise for all assigned product areas.
- Serve as the Regulatory Affairs representative on assigned non-product related cross-functional teams.
- Coordinate or oversee preparation of regulatory documentation in a timely manner to meet corporate objectives.
REQUIREMENTS
- MSc. in Life Sciences
- Experience in the pharmaceutical, biopharmaceutical, medical industry
- 5 years of experience in regulations, compliance and value dossier submission.
- Excellent technical writing
- Excellent communication skills with key individuals inside and outside the organization
- Good team player skills
- Accurate, Multitasking, Prioritizes and meets Deadlines
- Good knowledge of Dutch, French, English (trilingual)
Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Laura Hoekstra.
