Regulatory Affairs Officer
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 Pharmaceutical organization, based in Groningen Netherlands.
Our client operates on a global scale and deals with active pharmaceutical ingredients (API) for human and veterinary medicines. The company focuses on R&D, manufacturing and distribution.
ROLE DESCRIPTION
The company offers a versatile function in which you are mainly responsible for compiling relevant product information and ensure correct registration.
RESPONSIBILITIES
- Develop and maintain active substance master files (ASMFs)
- Create and managing confidential disclosure agreements (CDAs)
- Supervise legal guidelines and advise internal organization in RA
- Liaise with stakeholders and health authorities
- Keep track of changes in laws and regulations
REQUIREMENTS
- Bachelor or Master degree in Life Sciences or Chemistry
- min. 3+ years' experience as Regulatory Officer
- Experience in a GMP environment, experiences with FDA is a plus
- Good communication skills in English, Dutch is a highly appreciated
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.
Job Description
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!
THE COMPANY
Our client is a professional Pharmaceutical organization, based in Groningen Netherlands.
Our client operates on a global scale and deals with active pharmaceutical ingredients (API) for human and veterinary medicines. The company focuses on R&D, manufacturing and distribution.
ROLE DESCRIPTION
The company offers a versatile function in which you are mainly responsible for compiling relevant product information and ensure correct registration.
RESPONSIBILITIES
- Develop and maintain active substance master files (ASMFs)
- Create and managing confidential disclosure agreements (CDAs)
- Supervise legal guidelines and advise internal organization in RA
- Liaise with stakeholders and health authorities
- Keep track of changes in laws and regulations
REQUIREMENTS
- Bachelor or Master degree in Life Sciences or Chemistry
- min. 3+ years' experience as Regulatory Officer
- Experience in a GMP environment, experiences with FDA is a plus
- Good communication skills in English, Dutch is a highly appreciated
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.
Additional Information
- Last updated
- Employment type
- Full time
- Contract type
- Self employed
- Number of vacancies
- 1
- Min. experience
- Two years
- Min. education
- Bachelor
- Industry / category
- Jobs in Research and Development (R&D)
