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Head of Regulatory Affairs

Head of Regulatory Affairs

Barrington JamesLeiden, South Holland, Netherlands
30+ dagen geleden
Functieomschrijving

About the role

This is a very exciting opportunity for an experienced Head of Regulatory to join my clients growing team based in the Netherlands. This is truly a unique opportunity as my client is pioneering a new product in the food market focusing to begin with on cultivated meats which has never before received regulatory approval!

As a result, with two direct reports, you will be responsible for driving the regulatory approval to bring new GMO food products to market by defining and executing the regulatory strategy, liaising with relevant external authorities, guiding Assurance & Food Safety, and ensuring overall compliance once the product is on the market.

Day-to-day you will be responsible for working with regulators to define production standards and approval requirements for this new field, and leading the regulatory approval processes. My client is an established organisation but with a start-up / entrepreneurial feel and are 'truly' unconventional in their vision and approach. They are looking for innovators, someone who is hands on, has the experience in previously brining GMO products to market and being willing to get stuck in and drive the development of the regulatory approval for their products globally, working cross-functionally internally from day one.

Ideally you will have a scientific background, understanding lab work with a scientific spike in an area like biochem, toxicology or similar, furthered by a demonstratable career in Regulatory Affairs specifically with gaining approval for GMO, protein, special medical ingredients or similar products. (P harmaceutical and small molecule experience is not relevant enough because the regulatory pathway is relatively well trodden, whereas GMO is very open and needs existing experience of successful approval to navigate ).

My client is well aware that they are asking for a very broad experienced and dynamic individual, but this is the nature of their work, they have a consultant covering the position as we speak and their input will form part of the decision making process so whilst the expectations are high, so is the potential for this 'career changing' role!

Responsibilities

  • Spearhead and develop regulatory strategy for novel food applications and other necessary regulatory clearances.
  • Work with interdisciplinary teams across R&D, manufacturing, and legal departments to ensure regulatory compliance in a changing landscape.
  • Develop, assess, and submit regulatory documentation while maintaining compliance with all statutory and quality standards.
  • Establish and cultivate strong connections with regulatory authorities, government officials, and industry partners leveraging your existing network to build strategies for market entry.

Qualifications

  • Master’s or PhD in Biotechnology, (Molecular) Biology, (Organic / Bio) Chemistry, Toxicology, or a related field; ability to deeply understand the production process and work closely with the science team.
  • Ideally 7-10 years of experience in regulatory approval processes, including hands-on experience managing novel food procedures approvals globally with special focus on EU, Latam and Asian countries.
  • Comprehensive expertise in food regulatory processes, including dossier preparation, submission, and influencing policymakers.
  • Strong communication skills to effectively engage with diverse stakeholders, from technical teams to senior policymakers.
  • Essential skills & experience

  • Scientific background (likely biochemist, micro biologist with some tox).
  • GMO regulatory approval or similar.
  • Successful regulatory dossier writing, critical data documents and authority research and comms.
  • Intuitive and innovative understanding approach to regulatory market, someone who understands safety, tox, interaction and feedback to R&D.
  • About

  • Fulltime contract from day one.
  • Competitive salary and packaged based upon experience.
  • 3 stage interview process.
  • Willing to hire the right person immediately .
  • If you are passionate about regulatory affairs, have a solid grounding in toxicology or a related scientific field (e.g., molecular biology, organic chemistry), and want to be part of helping to bring world changing products to market, this role is perfect for you and I would love to speak with you further about this exciting opportunity, your career aspirations and how you can add value to this growing team and innovative organisation!

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    Head Of • Leiden, South Holland, Netherlands