RA Non-Clinical Safety Expert - Amersfoort

Vacancy information

Publication date:May 26 2021
Employment type: Permanent
Sector: Feed/Animal Nutrition
Function Group: Quality/RA

Function Group: Quality/RA / RA Officer

Organization

For one of the global leaders in animal nutrition and aquafeed, we are currently seeking a Non-Clinical Safety Expert to join the regulatory innovation team. The mission of this organisation is to make a significant contribution to meet the rapid increase in the worldwide demand for food. They are operating in over 90 countries worldwide providing advanced nutritional solutions for their customers.

Function

As the Non-Clinical Safety Expert, you will be responsible for guiding worldwide project teams in both understanding the mechanisms of action of safety risks and in the early de-risking strategy for screening out relevant project concepts of potential risk.

You will combine your experience in pharmacology / toxicology to work at the forefront of translational science that will transform the feed industry in a broad range of product concepts in both animal nutrition as aquafeed. With the aim to establish and maintain a worldwide portfolio of proprietary and innovative products & concepts that are safe and compliant with relevant law and regulations and enhance the speed to market.

Furthermore, you will:

  • Guide and oversee the Safety Pharmacology and Toxicology activities in support of development of new product concepts
  • Provide scientific and regulatory vision and demonstrate leadership within project teams
  • Communicate non (clinical) safety findings and perspectives to cross-functional teams, and effectively interact with partners and collaborators across all levels
  • Support current marketed products with regards to regulatory questions or adverse events
  • Be updated with regulatory guidelines within the field of safety pharmacology research
  • Monitor and provide guidance in external safety studies with CRO’s
  • Plan and design both non GLP and GLP toxicology studies that will support submissions
  • Plan and coordinate of regulatory support in innovation
  • Give go / no go decisions from a safety perspective in the stage gate process in projects

Requirements

In this role as Non-Clinical Safety Expert, you need to be content driven but able to articulate this to non-scientific people. You will build close relationships with a broad range of colleagues across the entire chain of product development.

In order to fulfil this role in a proper way, the perfect candidate needs to meet the following criteria:

  • Master, PhD or DVM with 5+ years of relevant technical experience in Toxicology in the Pharmaceutical or Animal Health sector
  • Strong scientific background and aptitude
  • Being able to manage multiple projects in a regulated environment with changing deadlines and priorities across different business units
  • Proactive, enthusiastic, able to work in a fast-paced environment and make quick, but thoughtful decisions
  • Strong organisational skills, attention to detail, and time-management skills enabling efficiency and independence
  • Languages: fluent English, both verbal and written

Offer

Working for this organisation means a fantastic position in an international working environment with lots of development opportunities.

Moreover, you will enjoy having:

  • Challenging work on complex and very diverse Toxicology related topics
  • A multi-cultural working environment with great colleagues
  • Opportunity to develop an international career in regulatory affairs
  • No-nonsense, pragmatic, flat organisation, with direct reporting lines
  • 30 vacation days
  • Attractive salary based on skills and experience
  • Health and travel Insurance

Application

If you are interested in this job, or in similar ones, please feel free to contact me directly.

Walid Sharaf
Consultant | Food, Feed & Plant (Sciences)

+31 6 82 63 49 23
+31 23 754 86 60
w.sharaf@qtcrecruitment.com

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