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Regulatory Affairs Specialist (CMC)

SIRE Life Sciences®

Belgium, zagranica

SIRE Life Sciences®

Regulatory Affairs Specialist (CMC)

Location: Belgium

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 Antwerpen Belgium.

The company is an international operating organisation, where you can advance yourself and have long term career opportunities.

ROLE DESCRIPTION

In this role you'll be responsible for a team and its accomplishments. CMC submissions is a vital part of this team. Therefore, understanding specific regulatory guidance and experience of focus and interpretation of guidelines by national authorities contributes significantly to the success of regulatory submissions.

RESPONSIBILITIES

- Experience within the CMC submissions; preparing and submitting registration dossiers
- Providing effective supervision to ensure the quality, accuracy and deadlines
- Determine strategies for the submission of registration dossiers
- Extending knowledge of current government regulations and worldwide requirements applicable to every stage of the registration process
- Interplay between clients, governmental bodies and health authorities worldwide

REQUIREMENTS

- Minimum bachelor degree in life science related field
- Minimum of 3 years of experience in the regulatory affairs
- Experience and knowledge within CMC
- Excellent communication and writing skills in English, preferably Dutch
- Experience in leading a team, delegating and decision-making
- Flexibility to adapt to a changing regulatory environment
- Good technical writing skills

Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Laura Hoekstra.

Prosimy o aplikowanie poprzez przycisk znajdujący się po prawej stronie ogłoszenia.
SIRE Life Sciences®

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