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Regulatory Affairs Manager

Regulatory Affairs Manager

Functieomschrijving

As a result of a new project we are now seeking a Regulatory Affairs Manager

MAIN RESPONSIBILITIES

  • Management of 3rd party partners, building strong relationships for assigned project(s), in line with the Regulatory Lead
  • Compile, or supervise the compilation of regulatory dossiers in accordance with national requirements.
  • Gain regulatory authority approval.
  • Provide on-going regulatory advice to project teams to ensure regulatory concerns are planned and accounted for and the relevant data are generated to meet project objectives.
  • Provide regulatory support to clients and associate companies.
  • Liaise with external regulatory authorities as required.
  • Provide format and contents review of packaging texts, Summary of Product Characteristics, Patient Information Leaflets and labelling.
  • Review tasks for, support and mentor Regulatory Affairs Officers and Associates.

Original text


Profiel

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

EDUCATION & EXPERIENCE

Life Sciences related fields (Bachelor’s or higher graduate degree in a science related field)

Minimum of 5 years ‘experience, this experience should include a proven understanding of the regulatory process and experience in leading a project to successful completion.

Skills

  • Experience in a regulatory affairs department
  • Knowledge of medicinal products registration/life cycle maintenance in Europe (NP, MRP,DCP and CP)
  • Knowledge of EU and Belgium registration
  • Experience in Labelling in Belgium
  • Process orientated with good attention to detail
  • Effective oral and written English communication skills
  • Fluent in English for daily contact with internal and external partners, also Dutch or French is required

Aanbod

Translated to:
English
Show original

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

§ International and growing company;

§ Flexible working environment;

§ Health insurance;

§ Meal tickets

Original text


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