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Regulatory affairs manager CMC

Regulatory affairs manager CMC

Functieomschrijving

To develop a new project, we are looking for a Regulatory affairs manager CMC for one of our clients

MAIN RESPONSIBILITIES

Regulatory compliance

Scientific support for the preparation of regulatory dossiers (active substances module 3 CTD).

Participate in the selection and justification of Registered Starting Materials (RSM) and their characterization.

Evaluation of technical information on processes developed/optimized by R&D or "Technical packages".

Identification of associated quality and regulatory risks

Management of risk analyses of elemental impurities, genotoxics and nitrosamines

Writing scientific reports and documents related to your field of expertise

Elaboration of the strategy for the control of active substances

Original text


Profiel

ProductLife Group applies the principles of equality and diversity
in the workplace and opposes all forms of unlawful discrimination.

Education and Experience

Bachelor’s or higher graduate degree in a science related field

At least 3 years’ experience in regulatory affairs department (Chemical product, Medical Device, Biotech, Biologics)

Skills

Good knowledge of regulatory procedures (EU/ France)

Knowledge in CMC

Good understanding of regulatory tracking database software, eDMS, MS Word, MS Excel

Experience in CMC writing (Variation package) will be appreciated

Skills in organic chemistry

Knowledge of the usual analytical methods (LC-UV, LC-MS, GC-FID, etc...) and ICH standards.

Fluent in English and French and another European language for daily contacts with local and international partners //

Aanbod

§ Dynamic environment with opportunities for advancement within the company or the wider group;

§ International and growing company;

§ Flexible working environment;

§ Health insurance;

§ Meal tickets

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