Freelance RA Manager
Location: NetherlandsThe Company
The company its medical and scientific expertise contributes to high quality medical input, continuing the growth of their company.Role Description
As a RA consultant you will be involved in the preparation of regulatory submission and ensure that these are followed up and are updated in the system, this all on a freelance basis.Responsibilities
- Advance project requirement specifications and manage all aspects of project work- Maintaining regulatory files and records of contact with Regulatory Authorities
- Stay up-to-date with knowledge of relevant regulations
- Provide support to the execution of global registration and pharmaceutical development strategies
- Management of strategic and technical support during the introduction of the products
- Uphold the life cycle management of the clients current product line
- Create and manage product information/labelling text for templates
Requirements
- Bachelor degree (or higher) in life science- A minimum of 2 years experience in regulatory affairs
- Good experience with Diabetes, Cardiovascular a plus
- Good knowledge of international legislation, and thorough understanding of drug and biologics guidelines and regulations
- Excellent communication skills in English, and Dutch
Opis stanowiska
The Company
The company its medical and scientific expertise contributes to high quality medical input, continuing the growth of their company.Role Description
As a RA consultant you will be involved in the preparation of regulatory submission and ensure that these are followed up and are updated in the system, this all on a freelance basis.Responsibilities
- Advance project requirement specifications and manage all aspects of project work- Maintaining regulatory files and records of contact with Regulatory Authorities
- Stay up-to-date with knowledge of relevant regulations
- Provide support to the execution of global registration and pharmaceutical development strategies
- Management of strategic and technical support during the introduction of the products
- Uphold the life cycle management of the clients current product line
- Create and manage product information/labelling text for templates
Requirements
- Bachelor degree (or higher) in life science- A minimum of 2 years experience in regulatory affairs
- Good experience with Diabetes, Cardiovascular a plus
- Good knowledge of international legislation, and thorough understanding of drug and biologics guidelines and regulations
- Excellent communication skills in English, and Dutch
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)