Regulatory Affairs Specialist (m/f)

Job content

Arxada is a pioneering leader with a powerful legacy: Over 120 years of creating specialty chemicals and solutions that potentiate the performance of our customers and their products. Our solutions, our expertise and our support help them to perform better - to be more efficient, more effective and more sustainable. We are passionate about empowering high performance and enabling our employees, partners and customers to realize their full potential. Together we make daily life safer, cleaner, healthier and greener. If you like making a difference, we are the company for you!

We have an exciting opportunity for a Regulatory Affairs Specialist (m/f) to join the team supporting our Hygiene, Home & Personal Care (HHPC) business, based in Blackley, UK. In this role you will operate in a matrix organisation working with a team of regulatory managers, specialists and professionals. You will work in cross-functional project teams, be responsible for providing regulatory and technical expertise and help to deliver a complex regulatory program which supports the objectives of the HHPC Business.

Key Responsibilities:

• Works within a team of regulatory Managers, Specialists and Professionals plus cross-functional project teams in a matrix organization
• Provides analysis of biocide & chemicals policy, regulations, guidelines, standards etc., to support the development of business and regulatory strategy for managing compliance and marketability of products.
• Helps to identify and leverage regulatory opportunities to develop positions for substances and products which are new to Arxada.
• Co-ordinate the compilation of complex dossiers in close co-operation with the EMEA Commercial Team, Technical Team and the Regulatory Teams. Including the preparation needed prior to submission & managing post submission activities, with a view to achieving a favourable outcome for Arxada. Include discussions with agency officials or other stakeholders whilst developing and maintaining good relationships.
• Support the product development programme to guide cross‑functional product development/innovation teams. May include, for example, acting as subject matter expert, data gathering, compilation of necessary studies as well as supporting development of new studies where required.
• Provide guidance on product marketing initiatives assuring their compliance with regulatory requirements and regulatory strategy
• Provide effective and timely support to both internal and external customers often acting as the interface to key customers

Key Requirements:

• BSc. Degree or higher in Life Sciences and 5+ experience in a Regulatory Affairs position
• Excellent knowledge of the EU regulatory framework for biocidal products. Knowledge of allied regulations (Medical Device Regulation, Cosmetics Regulation, REACh, CLP, etc.) would be a bonus.
• Also desirable would be experience with a wide range of disinfecting active substances as would experience of disinfection in the food & beverage or animal biosecurity industries.
• A good understanding of chemistry, efficacy, toxicology, ecotoxicology, environmental fate, or, risk assessment methodologies.
• Ability to grasp new concepts quickly and to assimilate/evaluate scientific data
• Ability to work under pressure and to strict deadlines with attention to detail
• Ability to work independently and as part of a team in a matrix organisation
• Strong influencing/negotiation, written and oral communication skills

Arxada - Potentiating Performance