Senior Regulatory Assurance Manager - EMEA

Lonza Solutions AG (Basel, Schweiz) Vor 6 Tagen veröffentlicht

Today Lonza is a global leader in life sciences. We are more than 15,000 employees in more than 100 locations around the world. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world. And that’s the kind of work we want to be part of.

Lonza Specialty Ingredients (LSI) is looking for a Senior Manager in Regulatory Assurance based either in Basel, Switzerland or in Blackley, United Kingdom. You will provide a high level of expertise and guidance to both the Microbial Control Solutions (MCS) and the Specialty Chemical Services (SCS) Business Units, with particular responsibility for the delivery of the European REACH chemicals registration compliance program. This includes developing an appropriate regulatory strategy which supports the business strategy, leading a team of regulatory professionals to implement it and delivering a responsive, efficient, regulatory service to internal and external customers.

Key responsibilities:

  • Manage the delivery of the European Chemicals Registration Programs (e.g. EU REACH, UK REACH, Turkey, Russia etc.) for EMEA, including development and implementation of regulatory strategies for chemical substances and products in coordination with Business and RA leaders.

  • Manage and implement the strategic and tactical efforts for the registration of chemical substances in order to provide an efficient and responsive service that is compliant with all applicable laws.

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

  • Maintain expertise and knowledge of other global chemical regulations and use this to provide direction and guidance to chemical registration activities and programs in other global regions.

  • Ensure the coordination, preparation, submission and follow up of chemical registration activities, including the development and management of supporting study programs.

  • Provide guidance on innovation projects and product marketing initiatives assuring their compliance with regulatory requirements.

  • Proactively monitor opportunities and threats arising from new regulations and standards.

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

  • Take responsibility for managing agreed budgets in the context of above activities, ensuring alignment of both operational and capital planning.

Key requirements:

  • Master degree in Life Sciences or Chemistry; post graduate qualification is a plus.

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

  • Extensive practical experience in Regulatory Affairs (ideally in EU REACH related activities) with some knowledge of allied regulations (Biocides, Cosmetics, CLP, Medical Devices, Pharmaceuticals, Plant Protection Products, Prior Informed Consent, etc.).

  • Demonstrated experience in representing an organization externally and established relationships with appropriate EU agencies (ECHA) and national authorities.

  • People management experience.

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

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

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

Every day, Lonza’s products and services have a positive impact on millions of people. For us, this is not only a great privilege, but also a great responsibility. How we achieve our business results is just as important as the achievements themselves. At Lonza, we respect and protect our people and our environment. Any success we achieve is no success at all if not achieved ethically.

People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences. In return, we offer the satisfaction that comes with improving lives all around the world. The satisfaction that comes with making a meaningful difference.

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Senior Regulatory Assurance Manager - EMEA

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