![Barrington James](https://media.trabajo.org/img/noimg.jpg)
Regulatory Specialist
il y a 3 semaines
Brussels, Belgium
- 12-04-2023
- JOB TYPE
- Contract
- EMP TYPE
- Full-Time
- EXPERTISE
- Regulatory Affairs
- SALARY TYPE
- Hourly
- SALARY
- Negotiable
My client provides international regulatory affairs support at all stages of product development, from preclinical, clinical development and up to and beyond marketing authorization. Due to their increase in work, they are seeking a Regulatory Affairs Specialist/Expert to join their current team of specialists on a contract basis, with occasional visits to Belgium.
**Responsibilities**
- Guidance to different customers on the regulatory requirements for approval of a first in human clinical study
- Writing of Regulatory documentation including IMPD's, IB's, ODD's and CTA's in close collaboration with the customers and medicine agencies
- Participate in Scientific Advice / interact meetings requests with EMA and FDA
**Requirements**:
- Scientific degree
- A minimum of 3 years' in Regulatory Affairs in pre-marketing for medicinal product development
- Experience in writing Regulatory documentation such as IB's, PIP's, ODD's etc.
- Fluency in English (oral, written); a good command in French and other European languages are a plus
- Well-organized, flexible, rigorous, dedicated
If this sounds like you, reach out now to discuss
LI-JS
LI-Hybrid
Consultant
- Joshua Shapland
- +441293776644
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