#

Scientific Integrator (Regulatory CMC Dossier Development)

SIRE Life Sciences®

Belgium, zagranica

SIRE Life Sciences®

Scientific Integrator (Regulatory CMC Dossier Development)

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.

Their goal is to develop and make innovative medicines and ensure that these are available for doctors and patients world wide.

ROLE DESCRIPTION

Drawing on relevant expertise and information from both internal and external sources, make a major contribution towards the preparation of any CMC documentation of specified CMC submissions.

RESPONSIBILITIES

- Drive the Module 2 and 3 quality sections and ensure that they are compliant and fulfill expectations.
- Write global marketing authorization submissions, clinical trial submissions, and respond to health authorities.
- Provide interpretation of relevant CMC guidelines (ICH, FDA, EMA, etc.)
- Provides prompt regulatory risk assessments and recommendations.
- Mentor others in RA guidance.

REQUIREMENTS

- Knowledge of both large molecule and small molecule pharmaceutical CMC development.
- Some years of relevant industry experience (chemical development, pharmaceutical development, analytical development, post-doctoral, graduate course work)
- Demonstrate focus and clarity of thought under ambiguous or complex situations with minimal supervision.
- People management and negotiating skills
- Excellent verbal and written English language skills.

OTHER

Must be able to work flexible hours to accommodate early morning/evening meetings/ teleconferences with different time zones. Occasional international travel (3-5x/year) may be required.
Minimum 32 hours per week available - full time preferred.

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

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

Czy chcesz otrzymywać oferty pracy na podobne stanowiska?

Utwórz powiadomienie e-mail
Zapisz mnie

Zapisani kandydaci otrzymują informacje jako pierwsi.

Podziel się ze znajomymi