381 days ago on sire-search.com

Regulatory Affairs Director - Pharma

SIRE Life Sciences

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Regulatory Affairs Director - Pharma

SIRE 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!


Our client is a professional Pharmaceutical organization, based in Basel-Stadt Switzerland.

Our client is a manufacturer of (HP) API's.


Responsible lead of the new Regulatory Affairs (RA) department including two existing RA-groups.


- Ensure the timely compilation of regulatory dossiers for our active pharmaceutical ingredients (APIs)
- Furthermore you ensure regulatory compliance of our APIs.
- Expert for regulatory questions you collaborate with all internal and external stakeholders providing advice and appropriate decisions


- 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
- Fluent in German and English
- Independent, dedicated and initiative personality
- Very good organizational 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 Daniel Woudenberg.