Senior Regulatory Assurance Manager - EIMEA

Switzerland, Basel
United Kingdom, Blackley

At Lonza Specialty Ingredients (LSI), we combine technological innovation with world-class manufacturing and regulatory excellence. We are a leader in Microbial Control Solutions and chemical technologies used in various applications including hygiene and home care. Today, these solutions are more critical than ever to maintain the hygiene and safety of hospitals, homes, schools, and offices across the world. Our Specialty Chemical Services business provides composite materials for technically demanding industries and performance intermediates & chemicals. Our Custom development and manufacturing team has already brought more than 1,000 unique solutions to life for their customers.
 

We are a highly dynamic group of 3,000 employees in more than 25 countries around the world. For us, performance, collaboration, passion and care are fundamentals. Are YOU someone who CARES about finding unique solutions for customers, who is PASSIONATE about making a difference? We are looking for talent who embrace COLLABORATION and are motivated by a PERFORMANCE culture.

Within our microbial control business, we are now looking for a Senior Regulatory Assurance Manager to support our Crop Protection business, which offers customers a range of agro-chemistry and formulations for global agricultural markets. In this exciting, central and important role, you will be a “hands on” contributor located at our offices in Basel (CH) or Blackley (UK). As subject matter expert, you will provide a high level of expertise and guidance to the crop protection business, as well as the leadership needed to develop appropriate regulatory strategies. In addition, you will have the opportunity to manage a small team of regulatory professionals and ensure the delivery of a responsive, efficient, regulatory service to internal and external customers.
 

Key responsibilities:

  • Manage the strategic and tactical efforts for the registration of active substances and plant protection products, primarily in the EMEA region, in order to provide an efficient and responsive service that is compliant with all applicable laws.  This includes the development and implementation of regulatory strategies for active substances and products in coordination with Business and other Regulatory leaders.  

  • Ensure the coordination, preparation, submission and follow up of active substance reviews/approvals, plant protection product registrations/authorisations including the development and management of supporting study programs.

  • Provide guidance and direction for responding to product challenges.  Pro-actively monitoring to identify opportunities and threats arising from new regulations and standards.

  • Ensure effective support for innovation activities and provide guidance on product marketing initiatives, assuring their compliance with regulatory requirements.

  • Promoting a strong sense of commercial orientation to deliver effective customer support in alignment with Business and regulatory strategy.

  • Lead, manage and direct a small team, establishing clear performance expectations and ensuring alignment with business objectives. 

  • Maintain relationships with key regulatory agency officials, standards setting and industry consortium groups.

  • Lead and manage advocacy initiatives as agreed with RA and Business leaders.

  • Support the budget setting process and manage agreed budgets to ensure alignment of both operational and capital planning.

Key requirements:

  • A first degree in Life Sciences or Chemistry. A post graduate qualification is desirable.

  • In depth knowledge and experience of the EU Regulatory Affairs framework for Plant Protection Products with some knowledge of allied regulations (Food / Feed additives, REACh, CLP, etc.).

  • Strong technical expertise with understanding of chemistry, efficacy, toxicology, ecotoxicology, environmental fate, or risk assessment methodologies.

  • Demonstrated experience in representing an organisation externally and established relationships with appropriate EU agencies (eg. EFSA) and national authorities.

  • People management experience with proven track record of being a leader, motivator and engager of productive teams.

  • Demonstrated skills managing priorities and project timelines in a complex matrix environment.

  • Fluent in English with exceptional communication, negotiation and interpersonal skills.

  • Strong analytical, planning and prioritisation skills. Ability to digest large, complex volumes of data and summarise for effective communication.

  • Naturally collaborative with a proven ability to partner and influence others at all levels of the organisation.

A major part of the heritage of LSI is being able to deliver unique solutions to our customers. Being the driving force behind this approach – listening, asking, understanding to match the right elements in a new way has been an inherent part of our day-to-day business. Always with the goal to enable a competitive advantage for each customer with a specific product, package or solution. What makes YOU different?

Reference: R28825