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Regulatory affairs manager CMC

Regulatory affairs manager CMC

Functieomschrijving

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

MAIN RESPONSIBILITIES

  • Ensuring regulatory compliance for new products or for modifications
  • Sterilization validation
  • Constitution of technical files.
  • International registration of products
  • Management of microbiology with the laboratories concerned.
  • Release of sterile batches
  • Participation in the qualification and monitoring of suppliers
  • Support to the management of the quality system.
  • Customer quality support.
  • Participation in audits / inspections.
  • Providing support to project teams

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 10 years of work experience in a similar position in small molecule medicinal product development in the pharmaceutical/biotech industry

Skills

Proficient in CMC writing of chemical products. Knowledge of biological products, Knowledge of biological products (vaccines) is an asset.

Ability to mentor and coach staff

Innovative and problem-solving skills.

Technical knowledge: ICH guidelines, EMA guidelines, bioequivalence studies…

Ability to audit dossiers,

Good experience in client communication

Process oriented with good attention to detail

Effective oral and written communication skills

You are fluent in English for daily contacts with local and internationally 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

Bereken je reistijd
Naar
Productlife Group | Mechelen 2800

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