Regulatory Affairs Manager - CMC
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 Noord-Holland Netherlands.
A biopharmaceutical company with a wide variety of products, treating different health conditions such as central nervous systems disorders, autoimmune and rare diseases.
Will prepare the CMC documentation for international submissions in accordance with local requirements.
You will take part in the review and release of CMC documents in accordance with the procedures:
supervise the compilation of CMC dossiers.
Experience with several modules like 2 and 3.
Answer questions from health authorities and coordinate the response process;
- You are conversant with relevant, worldwide registration requirements;
- You are conversant with literature relevant to the projects and products;
- You make proposals to the organization with regard to variations of chemical and pharmaceutical documents, following questions from authorities: Additionally you consult with the departments involved.
- You take the initiative for and coordinate additional studies which are performed by the chemical and/or the pharmaceutical disciplines.
- At least a MSc (in Pharmacy, Chemistry or equivalent) or a BSc with multiple years of experience Several years of experience in CMC.
- A pharmaceutical background. Good command of written and spoken English and Dutch.
- Command of Dutch is an advantage Good social skills, communication skills and you are a team player.
- You have good organizational skills.
Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Linn Andenes.