Regulatory Affairs Specialist
2 weeks ago
Exciting opportunity to join the regulatory affairs team at an established and highly reputable chemical regulatory science consultancy. This is expansion to cover an increasing workload. The role is delivery focussed with no commercial or business development aspects. We are looking for a regulatory person for a purely regulatory delivery role.
This role will take a lead on physical/chemical properties/analytical methods and method validation for plant protection products. Duties will include:
- Providing clients with regulatory advice, including guidance on substance and product registrations strategies.
- Review active substance and product phys-chem data packages against regulatory data requirements and provide advice on strategies for filling identified data gaps.
- Assess method validation data following applicable guidance for analysis of technical active substances and formulations, residues in crop and environmental matrices.
- Facilitating communication with Competent Authorities on behalf of clients.
- Preparing technical reports and regulatory registration dossiers (e.g. draft Registration Reports (dRRs), Products Assessment Reports (PAR), technical equivalence dossiers and IUCLID dossiers in compliance with UK/EU guidance and regulatory requirements.
- Performing technical work including preparation of dossiers, data gap analysis, data review and interpretation, substance / mixture hazard classification and label reviews, in accordance with regulatory requirements and associated guidance.
- Writing scientific justifications and explanations to support waiving of regulatory data requirements and substantiate claims for safe product use.
- Commissioning, monitoring, coordinating, and interpreting experimental studies with external Contract Research Organisations
We would like to hear from candidates with a PhD / MSc in chemistry or similar subject, knowledge and understanding of PPP regulatory affairs and ideally, direct experience of physical/chemical properties/analytical methods and method validation. You could be from another consultancy, industry or the CRD.
You must have:
- A friendly and helpful attitude
- Be pro-active with ability to take initiative
- Strong verbal and written communication skills
- Strong organisational skills
- Strong problem solving and analytical skills
- Diligence and self-motivated.
- Knowledge of Reg 1107/2009
Key Skills: Regulatory affairs, registrations, PPP, plant protection products, crop protection, chemistry, physical and chemical properties, analytical methos, method validation, data gap analysis, study monitoring, dossier writing, draft registration reports, Reg 1107/2009
VRS Regulatory is the Regulatory Affairs and Risk Assessment division of specialist scientific recruiter VRS. We focus on recruitment in Regulatory Affairs, Registrations, REACH, CLP, SDS Authoring, Product Safety, Compliance, Risk Assessment, Regulatory Toxicology, Regulatory Ecotoxicology and Environmental Fate in the chemicals, agrochemicals and biocides sectors.
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United Kingdom VRS Regulatory Full timeExciting opportunity to join the regulatory affairs team at an established and highly reputable chemical regulatory science consultancy. This is expansion to cover an increasing workload. The role is delivery focussed with no commercial or business development aspects. We are looking for a regulatory person for a purely regulatory delivery role. This role...
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