Biologics Project Manager – Regulatory/Safety

LOCATION: Berkshire/ Remote   SALARY: Competitive   REF: ALS 2630

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On behalf of our client, a world-leading R&D company with state-of-the art facilities, we are looking to recruit an experienced Project Leader to manage biologics projects, supporting development, safety assessment and global registration of novel biological and biochemical plant protection products.

This role would suit a person with relevant scientific expertise and industrial experience in leading complex projects, who understands the techno-regulatory arena and is confident in external advocacy on regulatory safety requirements, particularly across the EU.

Remote working is a possibility, depending upon experience levels.


  • Excellent scientific expertise and technical specialism in biologics, especially microbials or macrobials
  • Wide-ranging knowledge of microbiology, molecular biology, biochemistry and biotechnology, combined with an understanding of physiology or toxicology.
  • Ability to communicate confidently with internal and external stakeholders globally, advocating technical positions effectively with regulatory agencies.
  • A demonstrated ability to lead complex projects, delivering technical leadership
  • Industrial experience is required
  • Toxicological expertise is desirable but not essential for this role, as can be trained
  • Experience of regulatory registration process for pesticides or related areas desirable
  • PhD in a relevant discipline, such as microbiology, biology, physiology, toxicology is preferred. BS or MS degrees and commensurate experience will be considered.
  • A high level of attention to detail and a strong capacity for critical thinking, problem formulation, data interpretation and evidence synthesis.
  • Excellent technical writing ability with strong verbal communication and presentation skills.
  • Strong interpersonal skills to gain commitment from both internal and external stakeholders, including the ability to quickly develop robust networks and key relationships.


  • Manage discrete projects in toxicology relating to the development, registration and ongoing support of biological and biochemical plant protection products.
  • Lead and contribute to projects so that they are properly specified, reviewed, and delivered on time and meet stakeholder needs. Contribute to the development of techno-regulatory strategies and project work plans.
  • Develop/deliver robust techno-regulatory hazard data packages and assessments to support new biological and biochemical plant protection product development and global registration.
  • Lead delivery of critical regulatory documents to support registrations, to time and quality.
  • Give internal and external presentations to enable development and business decisions and regulatory submissions to be made.
  • Communicate effectively with internal and external stakeholders, including managing direct relationships with global and regional regulatory teams and external regulatory agencies.
  • Use existing regulatory and novel strategies to assess potential toxicity of new products.
  • Provide technical expertise and written contribution to support the safety assessment.
  • Provide toxicological advice to multi-disciplinary teams responsible for product registration.

Agenda and its clients only recruit people who are passionate about animal care and welfare, people with integrity who are honest and trustworthy, and who have a great work ethic.  To enable us to hire the very best people, we will conduct a complete and comprehensive background and pre-employment screening as an essential part of the recruitment process.


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