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23.05.2016

CMC Regulatory Specialist

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 Flandre Orientale Belgium.

The company is focussed on therapeutic treatments and is a market leader in this segment.

ROLE DESCRIPTION

Single Point of Contact: interface between global Project Teams and local Team to manage on site all respective technical and / or life-cycle management activities assigned for specific projects

RESPONSIBILITIES

- Independent and timely compilation/preparation of state-of-the-art CMC regulatory documentation for global regulatory submissions and maintenance such as renewals, variations, dossier updates, compliance checks
- Prepare responses to health authority questions during development, registration, and product lifecycle
- Support the site in local and global change control procedure in order to meet cNTA and cGxP
- Participation in Health Authority GMP inspections and internal GMP audits
- Evaluation of regulatory requirements such as cNTA, cGxP, ICH and other guidelines, directives, regulations and pharmacopoeias on registered CMC documentation
- Regulatory support of Global Regulatory and local departments such as QA/QC/ Compliance, manufacturing/ MS&T, SC and finance departments

REQUIREMENTS

- University degree (WO) Master or PhD in Chemistry, Pharmacy, Biology, Biotechnology or a similar education, further education in Regulatory Affairs desirable.
- Excellent communication skills inn Dutch and English
- Minimum 5 years of professional experience in regulatory affairs in the pharmaceutical industry; leading interdisciplinary local and global teams within matrix organizations

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



 
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