RA CMC Specialist
Location: NetherlandsSIRE 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 Noord-Brabant Netherlands.
Our client is a leading biopharmaceutical company in the field of human medicine. It is a science-based company which is dedicated to help people fighting serious diseases.
ROLE DESCRIPTION
The RA department ensures that the company's products meet the appropriate legislation in order to control their safety and efficacy from early development to the coordination of approval and registration. The RA department is the crucial link between the company, their products and the regulatory authorities.
RESPONSIBILITIES
- Preparation of regulatory dossiers, CMC and labeling variations, renewal and referral applications
- Support with Clinical trials and development strategies
- Contact person for all regulatory related questions for biopharmaceutical products
- Liaise with Regulatory authorities with respect to MAA and regulatory strategy
- Maintain up-to-date knowledge of relevant regulations (EU, US, ICH) and gain regulatory intelligence by attending relevant meetings and conferences
REQUIREMENTS
- Bachelor degree in Life Sciences or Pharmacy
- min. 5 years' experience within the biotech/pharmaceutical industry in both pre- and post-market setting
- Profound knowledge of international regulatory submissions and an understanding of worldwide guidelines
- Specific experience with CMC
- Strong communication skills in English
Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Anja Paetel.
