CMC Regulatory Affairs Manager
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 multinational biopharmaceutical company who aims to save and improve lives. The focus of the company is on research and development of innovative medicines.
ROLE DESCRIPTION
The company offers a challenging role as CMC Regulatory Affairs Manager.
RESPONSIBILITIES
- Definition of the registration strategy for submissions worldwide
- Preparation and submissions of registration dossiers
- Focus on technical writing of CMC Module 2-3
- Ensure regulatory compliance
- Contact person for Health authorities
- Keep up-to-date with governmental and worldwide requirements
- Work in multinational project teams
REQUIREMENTS
- MSc/ BSc degree life sciences, chemistry or a related discipline
- Min. 3 years' experience in regulatory affairs and project/product development
- Experience with writing of CMC documents
- Strong communication skills in English
- Extensive knowledge of MS Office, Trackwise is a plus
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.
Opis stanowiska
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 Biotechnology and Pharmaceutical organization, based in Noord-Brabant Netherlands.
Our client is a multinational biopharmaceutical company who aims to save and improve lives. The focus of the company is on research and development of innovative medicines.
ROLE DESCRIPTION
The company offers a challenging role as CMC Regulatory Affairs Manager.
RESPONSIBILITIES
- Definition of the registration strategy for submissions worldwide
- Preparation and submissions of registration dossiers
- Focus on technical writing of CMC Module 2-3
- Ensure regulatory compliance
- Contact person for Health authorities
- Keep up-to-date with governmental and worldwide requirements
- Work in multinational project teams
REQUIREMENTS
- MSc/ BSc degree life sciences, chemistry or a related discipline
- Min. 3 years' experience in regulatory affairs and project/product development
- Experience with writing of CMC documents
- Strong communication skills in English
- Extensive knowledge of MS Office, Trackwise is a plus
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.
Dodatkowe informacje
- Ostatnia aktualizacja
- Wymiar etatu
- Pełny etat
- Rodzaj umowy
- Własna działalność
- Liczba wakatów
- 1
- Min. doświadczenie
- 2 lata
- Min. wykształcenie
- Wyższe licencjackie
- Branża / kategoria
- Praca Badania / Rozwój
