Regulatory Affairs Specialist, Biocides

Who we are
Science Group provides independent advisory and advanced product development services focused on science and technology initiatives. Our specialist companies, Leatherhead Food Research, Sagentia, Oakland Innovation, OTM Consulting and TSG Consulting, collaborate closely with their clients to deliver clear returns on technology, R&D and regulatory investments.

TSG Consulting prides itself on its proven track record in providing the highest possible professional standards in regulatory and scientific services to the chemical and biotechnology industries. Our multidisciplinary team of scientists, regulatory and registration specialists allows us to provide support across a range of areas, including strategic advice, data gap analysis, biocidal product family development/construction, dossier preparation and submission and task force/consortia management. We have extensive experience in dealing with regulators and with our network of regional offices; we provide a pan-European product registration service.

The opportunity
As a Regulatory Affairs Specialist, you will be responsible for advising on, and structuring solutions that guide our clients successfully through the complex regulatory and policy challenges within the EU. The broad scope of the work will challenge you to provide successful regulatory outcomes on applications for new active substances, and renewals of existing active substances, under Regulation (EU) 528/2012 (BPR) and in managing product registrations under National (transitional) rules and BPR (including product families).

Key responsibilities include:
Client management & delivery
• Plan, co-ordinate and deliver high quality work in an efficient and effective manner to meet deadlines, ensuring client satisfaction and enhancing long-term client relationships
• Advise and support clients through the regulatory process, including provision of guidance on strategy, preparation of product registration applications, collation of biocidal active substance and biocidal product dossiers, and use of ECHA IT tools such as IUCLID and R4BP.
• Engage in interactions with regulatory authorities and relevant industry bodies in conjunction with the client as required.
• Regularly communicate with clients and the project team to ensure client requirements are understood and expectations are met
• Develop and maintain a comprehensive understanding of the current and future regulatory landscape.

Business development
• Provide support to business development activities by providing industry expertise when needed during visits to clients, through discussion and responses to new project briefs and administration.
• Work with colleagues to foster a collaborative and cooperative environment not only within your business area but also focusing on developing links with other business areas in the Group

Project guidance
• Engage and work with multi-disciplinary teams, including geographically dispersed teams based in other countries/Member States to help deliver client outputs.
• Support members of your project team and colleagues in providing advice to clients and in relation to any project issues they may encounter
• Be a Champion of Excellence, striving for continuous improvements to the way we work, adapting to find solutions to issues

The ideal candidate would also be responsible for:
Microbiology/efficacy specialist support
• Knowledge on microbiology and CEN standards
• Assist with the completeness/quality review of scientific data according to current European Regulations, Directives and guidelines.
• Prepare regulatory summaries, waivers and other regulatory documentation.
• Peer review of summary dossiers and regulatory documentation prepared by other TSG consultants.
• Review of study plans and reports to ensure that regulatory and scientific requirements are achieved.
• Consultancy and regulatory services, provision of general regulatory and scientific consultancy to clients as required.

About you
We are seeking an experienced, committed individual with a minimum of two years’ experience of working in the biocides industry or in a regulatory authority position. A degree in a relevant scientific subject e.g. chemistry, biology, microbiology or a relevant discipline would be advantageous, however we need you to have a sound working knowledge of Regulation (EU) 528/2012 (BPR) and demonstrate excellent written and organisational skills with a proactive, positive and enthusiastic “can do” attitude. You should be a motivated individual able to adapt and keep pace with regulatory developments and enjoy solving complex regulatory problems.

You will be able to confidently communicate with clients in order to identify their needs and provide advice, with the ability to be flexible, think strategically, accept and work with change. You will also effectively build working relationships with colleagues and external contacts to promote the company’s regulatory expertise.

Working for us
The biocides team at TSG is a group of project managers and regulatory specialists who are responsible for coordinating all biocidal product work at TSG. The team is friendly and supportive. There are opportunities to work with a diverse range of clients, both small and large, who are based around the globe. Project types are varied and challenging. The team work closely with colleagues in specialist areas including toxicology, chemistry, environmental science and human health risk assessment.

Career development
You will have bespoke training and mentoring to allow you to thrive within our environment and fully realise your personal potential.

Benefits
You will be offered a competitive salary and benefits package.

 

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