Location: NW UK or Switzerland
Salary: Commensurate with skills and experience (plus excellent benefits)
Our Client now has a vacancy for a Regulatory Manager in its Consumer Products Ingredients segment. This is a key role and you will be required to provide a high level of expertise and guidance to business units within the Division from your knowledge of Biocides and Medical Devices.
You will be an in-house regulatory expert and lead on disinfectants and other healthcare related activities and be the main liaison with Government Authorities and Notified Bodies for Medical Devices. You will support the development of the regulatory strategy, subsequent delivery and registration to both internal and external customers.
Your key responsibilities will include:-
Preparation of technical documentation for Medical Devices and compliance of the planned portfolio with all relevant regulation. You will advise the business team, QA and external Manufacturing teams and relevant functions around the requirements of legislation.
You will also be the regulatory lead person for assigned biocidal active substances and be the go-to person for such matters. You will manage the co-ordination, preparation and submission for active substances and product registrations within the EMEA region. Activities may include the co-ordination of relevant studies, negotiating with external regulatory authorities to ensure favourable outcomes and providing regulatory support to other functions and customers.
You will be:-
A strategic thinker with excellent networking skills and highly developed communications skills. You will be able to negotiate effectively both internally and externally at high levels. You will be a natural collaborator and influencer and operate with integrity and professionalism with an ability to adapt and grasp new concepts quickly and effectively and be able to evaluate scientific data objectively and under pressure to strict deadlines whilst maintaining a high attention to detail. You should be able to work both autonomously and as part of a team leading and contributing as appropriate and a true regulatory expert in your field.
You will have:-
- Post Graduate Degree in Chemistry, Toxicology, Ecotoxicology, Biochemistry or Pharmacology
- Further training in Toxicology or preparation of technical documentation for submission is preferred
- Significant experience in regulatory affairs including Biocides and Medical Devices
- Excellent Working Knowledge if EU regulatory framework for biocides and medical devices
- REACH, CLP, plant protection and prior informed consent knowledge is preferred
- Experience and understanding of Chemistry, Efficacy, Toxicology, Ecotoxicology and environmental fate studies and risk assessment methodologies
Please call Lori Fitton to discuss in confidence on 01606 818290
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