Regulatory Affairs Associate

For one of our client located in Wallonia, we are looking for an experienced Regulatory Affairs Associate.

  • Do you have a Master Degree in Life Sciences and at least 5-7 years of experience in Regulatory Affairs or Clinical Affairs within the pharmaceutical sector?

  • Do you have experience in eCTD-compliant regulatory submissions

  • Are you fluent in english?

Then, you might be the specialist that we are looking for!

Job Description 

As a Regulatory Affairs Associate, you take in charge several tasks.

Responsibilities 
  • You interpret applicable legislations, regulations and guidelines;

  • You review or interpret regulatory, clinical, scientific and other technical documents;

  • You provide guidance to ensure understanding and alignment of the company's objectives with applicable law and regulations;

  • You develop close working relationships with colleagues to provide counsel and advice on various regulatory issues and ensure solid and reliable compliance level across the business activities;

  • You write and prepare well-organized and scientifically sound regulatory documents including eCTD-compliant regulatory submissions;

  • You set clear expectations and provide clear direction to colleagues involved in providing input to RA department;

  • You ensure adherence to applicable requirements, accuracy, consistency, completeness of the documents, as necessary for the company's business objectives worldwide;

  • You manage the process of identifying key regulatory timelines and regulatory critical path activities;

  • You ensure the effective coordination and oversight of regulatory application processes involving internal and external resources leading to timely preparation of submissions;

  • You liaise with FDA and other health authorities to achieve timely clinical trial initiation and, ultimately, drug approvals;

Profile 
  • You have a Master Degree in Pharmaceutical Sciences, Life Sciences or equivalent with at least 7 years in pharmaceutical industry (preferably biotech), in a similar role of regulatory affairs or clinical affairs; or a PhD in Pharmaceutical Sciences, Life Sciences or equivalent with at least 5 years in pharmaceutical industry, in a similar role of regulatory affairs or clinical affairs;

  • You preferably have an expertise in a relevant specialist area relevant to Immuno-oncology or cell and gene therapy programs or automated cGMP manufacturing systems for cell-based therapies;

  • You have experience in eCTD-compliant regulatory submissions;

  • You have strong knowkedges of the principles of quality management or experience of working within a quality management system (e.g. GMP, GCP, GLP);

  • You have knowledges of European, US and International laws, regulations and guidelines for pharmaceuticals, biologics, medical devices, human cells and tissues, and combinations thereof;

  • You have strong written and verbal communication skills, including excellent attention to detail;

  • You are a good team player, used to working in multifunctional environments. You have the acility to build and maintain excellent working relations at all levels with a high regard for honesty, integrity, and professional ethics;

  • You have the ability to take the initiative and to work autonomously on selected topics;

  • You have proven the ability to manage complex projects and to organize heavy workloads effectively. You are able to re-prioritize workload to meet changing timelines; 

  • You have personal computer and data processing skills, Microsoft Office Suite applications in particular.

  • You are fluent in english English  (written and spoken), additional languages are an asset.

Contact Information 

Amandine Planche
 +32 2 588 16 07
amandine.planche@valesta.com

Application form : Regulatory Affairs Associate

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