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knoell is one of the leading global service providers in offering regulatory registration, clinical development and product development support to clients. Our team of scientific and regulatory experts and extensive network of partners ensures that all the different regulatory requirements are right from the project outset to support our client’s global business. People are at the heart of our family-owned business and our values guide the way to our success. Team spirit and mutual support are very important to us. Our culture is characterised by strong international co-operation, can-do attitude, focus on quality and a growth mindset.

Our strength is to be where it matters - think globally, act locally! 

OVERVIEW

Are you an experienced Regulatory Affairs professional with a passion for animal health? Do you thrive in a collaborative environment where your expertise can play a key role in preparing and managing regulatory projects within the EU and globally? Join our team as a Regulatory Affairs Specialist and play a vital role supporting clients by delivering projects on time, within budget and in compliance with regulatory standards

YOUR TASKS

  • Prepare and submit regulatory documentation to authorities.
  • Plan and manage regulatory procedures on behalf of client companies.
  • Review product labelling to ensure accuracy and compliance.
  • Communicate effectively with client companies and regulatory authorities.
  • Provide advice on regulatory strategy to clients.
  • Assist Project Managers with day-to-day tasks.
  • Participate in client conference calls and web meetings.
  • Support the preparation of project proposals within the company’s system.
  • Monitor and oversee project progress.
  • Review and manage monthly invoices related to projects.
  • Manage the authorisation and post-authorisation processes for animal health products according to national and EU regulations.
  • Ensure all project work aligns with current regulatory guidance and meets internal standards.
  • Build, maintain, and share practical knowledge within the team.

YOUR PROFILE

  • Educational Background: Master’s or PhD in a scientific discipline or equivalent.
  • Experience:
    • 5+ years in regulatory affairs, with at least 3 years specifically focused on European regulations for animal health products.
    • Familiarity with European animal health e-submission portals and labelling requirements.
    • Practical experience working with various National Competent Authorities (NCAs).
  • Skills & Traits:
    • Strong organisational and communication skills with the ability to manage multiple projects.
    • Proactive and team-oriented mindset with a commitment to continuous learning.
    • Up-to-date knowledge of regulatory developments and market trends.
    • Strong English language skills; additional languages are a plus.
    • Excellent working knowledge of MS Office.

WHAT WE OFFER

  • Work in a dynamic family-owned business environment with an international team in which new ideas, creative approaches, and collaboration are valued.
  • You will have the opportunity to work with market leaders in our industry.
  • Development is core, and at knoell we offer various opportunities to support your personal, leadership and technical development, including English language courses to help you effectively communicate in our business language.
  • knoell offers a flexible working policy and is a remote-first company, where you have the flexibility to work from home, at our headquarters in Mannheim or at one of our local offices based in your location. 
  • Part-time work options are generally supported on request subject to meeting business requirements.
  •  It is important to us that you have both a career and personal life – we celebrate the work-life balance of our colleagues.
  • At knoell we have a global employee referral program as part of the recruitment process where you can actively participate and get rewarded for referring talent to knoell.

 

We look forward to receiving your application!