Oh oh! Awesome! {$ msg.text $} ({$ msg.count $})
Regulatory affairs CMC consultant
I'm interested

Industry

Engineering Services

Category

All functions

Experience

Mid level

Applications are considered on a rolling basis

Location: Belgium

Visit website

Contact Person
Mathilde Bia

Job Description

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!

We Will Offer You

  • Insurances, a mobility plan of your choice and other benefits;
  • Integration in a solid and dynamic team;
  • Participation in exciting and motivating infrastructure projects;
  • Career evolution;
  • Training possibilities and official certification within our Capgemini Engineering Academy.

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.

  • 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 French/Dutch is a plus.
About the company

World leader in engineering and R&D services, Capgemini Engineering combines its broad industry knowledge and cutting-edge technologies in digital and software to support the convergence of the physical and digital worlds. Coupled with the capabilities of the rest of the Group, it helps clients to accelerate their journey towards Intelligent Industry. Capgemini Engineering has more than 55,000 engineer and scientist team members in over 30 countries across sectors including Aeronautics, Space, Defense, Naval, Automotive, Rail, Infrastructure & Transportation, Energy, Utilities & Chemicals, Life Sciences, Communications, Semiconductor & Electronics, Industrial & Consumer, Software & Internet.

Capgemini Engineering is an integral part of the Capgemini Group, a global leader in partnering with companies to transform and manage their business by harnessing the power of technology. The Group is guided every day by its purpose of unleashing human energy through technology for an inclusive and sustainable future. It is a responsible and diverse organization of over 340,000 team members in more than 50 countries. With its strong 55-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 2021 global revenues of €18 billion.

Get the Future You Want | www.capgemini.com

I'm interested