RA Interim Consultant
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 Brussel Belgium.
Our client produces a wide range of both generic and innovative products.
ROLE DESCRIPTION
You will be appointed for contract job as a Regulatory Affairs Project Manager, taking part in the development of regulatory strategies for new and existing company products. Further developing and managing Regulatory Submission project plans and ensuring all regulatory necessities are met. You report to the Sr. RA Manager.
RESPONSIBILITIES
- Develop clinically pertinent content, supporting regulatory submissions and reactions to regulatory studies by taking care of other activities related to assigned products and projects.
- Be on point on EMEA/FDA guidance and rule-making to foresee regulatory changes that can interfere with products and submissions
- Assess and document impact of future product changes on regulatory matters.
- Review labeling and promotional materials for assigned products for regulatory compliance
- Develop and implement Regulatory Strategies for the assigned project
- Prepare submissions for the assigned project that is required to ensure timely approval for market release
- Responsible for the licensing of the new product
REQUIREMENTS
- Bachelor´s degree in a science related discipline (or equivalent)
- A minimum of 5 years of experience working with Regulatory Affairs
- Good communication and writing skills in English (and Dutch) with the ability to communicate and work at all levels of the organisation.
- Ability to follow guidelines and successfully communicate scientific data in a structured manner.
- Experience with working in teams
- Be capable of developing and maintaining professional relationships with internal and external subject matter experts
- Strong attention to detail
Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Cees van Wezel.
