Clinical Regulatory Manager
Location: GermanySIRE 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 Bayern Germany.
Our client is a Pharmaceutical company with their offices in Bavaria
ROLE DESCRIPTION
Guidance of strategic development partners to ensure that external development teams provide appropriate and reliable data.
RESPONSIBILITIES
- Ensure that biowaiver, bioequivalence and clinical parts delivered are appropriate
- Identification of deficiencies in such dossiers and clinical data
- Communicate clinical risks related to developed product to ensure readiness for launch
- Develop clinical development strategies for projects and evaluate cost and timelines for such projects
- Due diligence of external partners on clinical capabilities
- Ensure quality compliance with GCP and Clinical regulatory requirements
- Interdepartmental role communicating with internal and external stakeholders such as customers, regulatory and quality departments
- Timely respond to module 4 and module 5 questions
REQUIREMENTS
- Life Science Degree
- Fluency in English
- At least 3 years of experience in Clinical Research
- Knowledge on Clinical studies
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.
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 Bayern Germany.
Our client is a Pharmaceutical company with their offices in Bavaria
ROLE DESCRIPTION
Guidance of strategic development partners to ensure that external development teams provide appropriate and reliable data.
RESPONSIBILITIES
- Ensure that biowaiver, bioequivalence and clinical parts delivered are appropriate
- Identification of deficiencies in such dossiers and clinical data
- Communicate clinical risks related to developed product to ensure readiness for launch
- Develop clinical development strategies for projects and evaluate cost and timelines for such projects
- Due diligence of external partners on clinical capabilities
- Ensure quality compliance with GCP and Clinical regulatory requirements
- Interdepartmental role communicating with internal and external stakeholders such as customers, regulatory and quality departments
- Timely respond to module 4 and module 5 questions
REQUIREMENTS
- Life Science Degree
- Fluency in English
- At least 3 years of experience in Clinical Research
- Knowledge on Clinical studies
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.
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 i rozwój (R&D)
