Senior Regulatory Specialist in Chemistry, Residues, and Dietary risk Assessment

Who we are
TSG Consulting provides 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 diversity of areas including: plant protection products, biocides, industrial and speciality chemicals and cosmetics. Our scientists have expertise in chemistry, human health, microbiology and environmental science.

The opportunity
Our Senior Regulatory Chemists are strong team players with extensive technical regulatory experience gained from working in industry, a regulatory authority or a consultancy. Using a broad range of technical knowledge, experience and familiarity with EU regulatory requirements for plant protection products, biocides and/or industrial and specialty chemicals (REACH) they are responsible for advising on, and structuring solutions that guide our clients successfully through the complex regulatory and policy challenges within the EU.

Skillset:
• Scientific knowledge and detailed understanding of relevant EU regulations for agrochemicals (e.g. Reg. (EU) No 1107/2009, Reg. (EC) No 396/2005) and biocides (e.g. Reg. (EU) No 528/2012)
• Knowledge of US residue chemistry test guidelines (OPPTS series 860), registration requirements and tolerance and exemption petitions (FIFRA/EPA)
• Working knowledge of relevant residues, metabolism and dietary risk assessment data requirements (e.g. Reg. (EU) No 283/2013), OECD and EU/US test guidelines and guidance for chemical and microbial active substances
• Awareness of evolving technical areas and the ability to anticipate their impact on techno-regulatory strategies
• Excellent communication in verbal and written format, including the ability to communicate uncertainty and risk analysis

Key responsibilities include:
• Work with other specialists as part of multi-disciplined project teams to deliver technical work including: the assessment of chemical identity, physico-chemical properties and methods of analysis data and dossier preparation for biocide and plant protection products.
• Author and/or review residues inputs into regulatory dossier sections for (methods of analysis and) residues
• Review existing datasets and develop techno-regulatory strategies to advise clients on how best to fulfil the residues and metabolism regulatory requirements for active substance approvals/renewals and/or product authorisations
• Help clients to devise, set-up and manage residue trial programmes
• Calculate maximum residue levels (MRLs) and estimate the transfer of residues into animal commodities
• Support clients on the procedures and evaluations required for setting of MRLs, MRL modifications, reviews and compliance in accordance with Reg. (EC) No 396/2005
• Perform dietary risk assessments using relevant (eg in the EU, PRIMo) and national models
• Attend meetings with clients and/or regulatory authorities as the technical expert for residues
• Contribute to business development activities, dealing with enquires and quotes and assisting with scheduling project work.
• Provide mentoring support and training to junior scientists and the peer review of technical documents.
• 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 for Excellence, striving for continuous improvements to the way we work, adapting to find solutions to issues

About you
We are seeking an experienced, committed individual who has broad scientific knowledge and a detailed understanding of the regulatory requirements involved in preparation of plant protection products and biocides dossiers. A degree in a relevant scientific subject e.g. organic chemistry, biochemistry or equivalent chemical discipline is essential, with at least 10 years’ experience gained from industry, a regulatory authority or contract research, consultancy position; this could be 5 years’ experience if you have a PhD.

You will feel confident communicating with clients in order to identify their needs and provide strategic advice, with the ability to be flexible, accept and work with change. Working well under pressure, both independently and as part of a team, you will have delivered high quality work within target deadlines in a client-focused environment.

You will have a self-driven approach to your own learning and development to further enhance your scientific expertise in what is a complex and ever evolving area, along with excellent written skills and have a proactive, positive and enthusiastic “can do” attitude.

Working for us
The Human Health team at TSG is very friendly and supportive and full of people passionate about what they do! There are opportunities to work with a diverse range of clients, both small and large, who are based around the globe and project types are varied and challenging.

You will be offered a competitive salary and benefits package with bespoke training and mentoring to allow you to thrive within our environment and fully realise your personal potential.

 

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