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Regulatory affairs CMC consultant

  • Applications are considered on a rolling basis
  • Brussels
  • Applications are considered on a rolling basis
  • Brussels

About Capgemini

Capgemini is a global leader in partnering with companies to transform and manage their business by harnessing the power of technology. The Group is guided everyday by its purpose of unleashing human energy through technology for an inclusive and sustainable future. It is a responsible and diverse organization of 270,000 team members in nearly 50 countries. With its strong 50 year heritage and deep industry expertise, Capgemini is trusted by its clients to address the entire breadth of their business needs, from strategy and design to operations, fueled by the fast evolving and innovative world of cloud, data, AI, connectivity, software, digital engineering and platforms. The Group reported in 2020 global revenues of €16 billion.

Get the Future You Want | www.capgemini.com

Our offer

At Capgemini Engineering we value excellence, care, responsibility, dynamism and innovation. We offer a job with variation that leaves plenty of room for initiative and development. In fact, we are not just offering you a job, we’re inviting you to be part of our community where we will provide you trainings, tools & grounds for professional and personal growth. Each career experience is assorted by an attractive salary package.

If you are a team player, if you recognize yourself in this profile and are not afraid of taking on challenges… Apply today!

Your role

Regulatory affairs in the pharmaceutical sector is key to ensure product quality, accurate clinical trials and patient safety required to reach and maintain the Market Authorization. The CMC writer is in charge of the writing and edition of CMC documents to support registration of new products, as well as to ensure maintenance of registered dossier. Your main responsabilities are :

  • Writing technical regulatory documents, as agreed with the business partners
  • Writing Module 3 regulatory documents
  • Writing Module 2 of regulatory files derived from completed eCTD
  • Writing response to questions raised by regulatory authorities on CMC matters
  • Liaising with SPOC to ensure adequate receipt of source documents
  • Review technical documents prepared by other CMC writers to ensure quality meets defined standards
  • Collaborate with SPOC and external partners to ensure the production and the review of CMC documents within agreed timelines

Your profile

  • Master degree in Life Sciences completed by a Regulatory Affairs degree/certificate and/or relevant experience
  • Good scientific background to allow edition and review of technical registration files, to analyze and understand scientific and regulatory legislations
  • Initial experience in technical CMC writing, preferably in the Pharmaceutical industry and vaccine-oriented (min 1 year, 2 years desirable)
  • Knowledge of regulatory procedures
  • Knowledge of EU/US variation legislation/guidance
  • Organizational skills and effective time management
  • Quality-oriented and attention to details
  • Fluent in written and oral English. Good level of Dutch is a plus.

Work with great people

Sander Theuns
Salesforce Functional Expert
"Capgemini provides me with the right challenges and empowers me so that I can learn and improve daily."
Christoffel Gilis
UX designer
"Idean, an Ideal place to work!"
Delphine Libioul
Project manager
"Capgemini pushes me to question myself, to go out of my comfort zone, to change perspectives"
Ward Lambrecht
Business Analyst
"I joined Capgemini because we share the same drive; to empower each other and to grow towards new sustainable heights"

Great Place to Work

  • Global company with European Management style

  • Entrepreneurship in a stable environment

  • Projects for big companies

  • True industry shapers

  • Work in a stable environment

  • Career development framework

  • We nurture your strongest asset; knowledge

  • Flat structure, no strict hierarchy

About the company

A global leader in consulting, technology services and digital transformation, Capgemini is at the forefront of innovation to address the entire breadth of clients’ opportunities in the evolving world of cloud, digital and platforms. Building on its strong 50-year heritage and deep industry-specific expertise, Capgemini enables organizations to realize their business ambitions through an array of services from strategy to operations. Capgemini is driven by the conviction that the business value of technology comes from and through people. It is a multicultural company of over 200,000 team members in more than 40 countries. The Group reported 2018 global revenues of EUR 13.2 billion.

1976Founded in 1967 in Grenoble by Serge Kampf as Sogeti.

1970The first company in the sector to offer consulting.

1975Acquisition of Cap and Gemini

1980First major transatlantic contract with the Los Angeles Time.

1998First multinational contract with General Motors

2000Group headcount surpasses – 50.000

2010Group headcount surpasses 100.000

2016Serge Kampf passes away

2017Celebrations for 50 years Capgemini

Olena Nikolashenko | Contact Person

I'm interested
Capgemini

Brussels
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