Regulatory Affairs Manager, EMEA

over 2 years ago
Full time role
Netherlands... more
Netherlands... more

Job Description

At Apeel Sciences, we look to nature to help the global food system improve quality, reduce waste, and ensure an abundant future for our planet.  

We believe that our most essential ingredient in our recipe for success is our people. We strive to cultivate an environment where everyone is welcomed, and can bring their full, authentic selves into everything they do at Apeel. Humility, Ingenuity, Leadership and Teamwork are the values that define us and how we work with each other, customers, and communities across the globe.

About This Role

The Regulatory Affairs Manager, EMEA will manage the regulatory program for Apeel Sciences’ food and crop protection portfolio across Africa, the Middle East, with special focus on Europe. As such, we are seeking an individual whose knowledge of regulatory requirements and practices in these regions is matched with exceptional organization and strategic planning ability. In this role you will be responsible for providing guidance to the business on regulatory requirements needed to obtain regulatory clearance for our food and crop protection products as well as supporting sales, marketing, and advocacy needs. Knowledge of regulatory requirements and processes for the authorization of food and crop protection products will be critical for success as you partner with our Technology, Operations, Marketing, and Sales Teams to develop robust regulatory strategies that ensure timely market access and freedom to operate as well as compliance with national regulations. 

You will report to our Director of Regulatory Affairs, and will be based in the Netherlands. You can expect at least 20% travel, or more as necessary. We are looking for you to join us immediately.

What You’ll Do

  • Develop and implement complex product regulatory strategies, including bringing new products to market and enabling strategic means of protecting the company’s market position. 
  • Create and maintain regulatory project plans to track progress of regulatory deliverables in accordance with business needs.
  • Prepare regulatory filings for submission to regulatory agencies in accordance with agency procedures and requirements and steward Apeel’s regulatory filings to ensure successful and timely approval.
  • Stay abreast of the evolving regulatory landscape to assess and communicate impacts to Apeel and our customers.
  • Assess changes to Apeel products and operations to evaluate the impact on existing regulatory clearances.
  • Develop and review Apeel internal and Apeel customer communication materials, such as position statements, marketing assets, technical reports, and other business documentation to ensure alignment with regulatory guidelines.
  • Act independently to anticipate business needs, research issues, identify options, and offer strategic regulatory solutions to avoid, mitigate, and/or overcome roadblocks.
  • Prepare documents, summaries, and presentations for senior leadership that communicate regulatory status, challenges, and proposed paths to resolution.
  • Build effective relationships with key internal and external stakeholders to advance Apeel’s interests, ensuring effective communication, information flow, and issue resolution. 
  • Lead regulatory and scientific advocacy initiatives in order to advance Apeel’s interests in Europe, Africa, and the Middle East.

WHAT YOU BRING 

Minimum Qualifications:

  • 3+ years developing and leading the regulatory strategy for food and / or crop protection products in the European Union.
  • Deep understanding of food and / or crop protection regulatory requirements, with a particular focus on the European Union. 
  • Experience working with a variety of business units to advise on regulatory requirements, process, and strategy.
  • Excellent verbal and written communication skills, with demonstrated ability to influence desired regulatory outcomes.
  • Business level proficiency in English (C1 or C2)

Preferred Qualification:

  • Experience working with trade associations representing the food and / or agriculture sector. 
  • Experience developing relationships with regulatory agencies in the food and / or agriculture sector.
  • Experience working on and leading cross-functional teams.
  • Highly organized with a strong sense of urgency and can quickly mobilize internal and external resources to respond to regulatory needs.
  • Business level proficiency in German and / or French

Apeel believes that the scale of our impact is determined by the teams that work with us. As such, we seek to build high-performing teams of people from various experiences and backgrounds who can collectively push our company into new realms. We seek a diverse pool of applicants and consider all qualified candidates regardless of race, ancestry, color, gender identity or expression, sexual orientation, religion, national origin, citizenship, disability, Veteran status, marital status, or any other protected status. If you have a special need or disability that requires accommodation, please let us know.

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