Regulatory Affairs Director
SIRE Life Sciences®
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SIRE® is the market leader in Life Sciences recruitment. We believe the recruitment market needs to gear up in technology and continuous innovation. We like technology, in a Life Sciences 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!Our client is a professional Pharmaceutical and Biotechnology organisation, based in Slough United Kingdom.
The CompanyOur client is a Pharmaceutical company in the Slough area.
Role DescriptionRegulatory Affairs Director
Responsibilities- Responsible lead of the new Regulatory Affairs (RA) department including two existing RA-groups.
- Ensure the timely compilation of regulatory dossiers for the active pharmaceutical ingredients (APIs)
- Furthermore you ensure regulatory compliance of the APIs.
- Expert for regulatory questions you collaborate with all internal and external stakeholders providing advice and appropriate decisions.
Requirements- Master or PhD degree in life sciences or pharmacy
- Several years of experience in the fields of RA and leadership
- Very good knowledge of the registration requirements for pharmaceuticals, at least for EU and US
- Familiar with format (IMPD, CTD) and content (CMC) of regulatory dossiers
- Knowledge on eCTD
- Very good organisational and communication skills
Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Riko Arends.