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Regulatory Affairs Specialist

Groningen area

Introduction

You will play a key role in enhancing Regulatory Services for clinical and commercial biological products manufactured in a complex and highly regulated environment. You will collaborate on projects on a global scale, while being encouraged to develop your skills and explore new career paths.

Location

Groningen area

Job description

Within the Quality team, you are the specialist responsible for Regulatory Affairs. The team shares a passion for getting things right the first time and operates with a strong customer focus. You are fully aware that customers depend on the accuracy, safety, and effectiveness of products and services that improve lives worldwide. Additionally, within the quality environment of the site, there are opportunities to further explore and collaborate on regulatory compliance activities that involve interactions with local and foreign health authorities.
Your responsibilities will include:

Regulatory Knowledge and Expertise:

  • Stay abreast of procedural and CMC-related regulations, monitoring pharmaceutical regulations and participating in specialized industry working groups.
  • Promote and capture regulatory services as part of our integrated offering, partnering with the business to define strategies.
  • Author and review CMC/CTD M3-Quality documents for clinical and commercial applications across various markets.

Regulatory Compliance:

  • Maintain customer product registration information and translate it into production and quality control master documents.
  • Participate in Change Control processes by defining regulatory requirements and ensuring compliance with evolving regulations.

Regulatory Reporting:

  • Drive adherence to key deliverables' plans, contributing to Global Regulatory Affairs reporting with a focus on regulatory services metrics.

Profiel kandidaat

To be successful in the role of Regulatory Affairs Specialist, you should demonstrate good adaptability to a dynamic work environment, agility in interactions with stakeholders, and a customer-centric attitude coupled with business acumen
Furthermore you bring:
  • At least a Bachelor's degree in Life Sciences (Pharmacy, Chemistry, Microbiology).
  • Several years of demonstrated experience in a CMC regulatory role within the biopharmaceutical industry.
  • Proficiency in biologics CMC regulatory requirements for clinical and commercial applications according to EMA, FDA, ICH would be a good asset.
  • English language spoken and written is a must

Company profile

Our client is a Pharmaceutical Company with different sites all over the world. This site in the Netherlands is a multi-product and multi-client biopharmaceutical site with development and manufacturing facilities for pharmaceutical products for both clinical trials (phase I, II and III) and commercial applications.

Contact

Questions or interested?

Monique Groenen
Senior Recruitment Specialist

groenen@my-recruitment.com

+31 6 1238 7775

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