Offer summary

Qualifications:

Bachelor's degree in life sciences or related field is required., Minimum of 5 years of experience in regulatory affairs, preferably in the pharmaceutical or medical device industry., Strong knowledge of FDA regulations and submission processes is essential., Excellent communication and analytical skills are necessary for this role..

Key responsabilities:

Lead the preparation and submission of regulatory documents to health authorities.

Collaborate with cross-functional teams to ensure compliance with regulatory requirements.

Provide strategic guidance on regulatory issues and product development.

Monitor changes in regulations and assess their impact on the organization.

Established in Newcastle upon Tyne (UK) in 2001, Enviresearch Ltd is a respected regulatory affairs and scientific consultancy dedicated to assisting the chemical industry in meeting their obligations under UK and EU chemical legislation. Our expertise spans plant protection products, biostimulants, biocidal products, and REACH-regulated substances. Our team, comprised of regulatory specialists and technical experts in chemistry, ecology, ecotoxicology, environmental fate, efficacy, and human health and environmental exposure risk assessment, provide comprehensive support across each step of the registration pathway for agrochemicals, biocidal products and REACH registrations in the UK and EU. With a well-established reputation for scientific excellence, our team actively participates in industry expert groups and contributes to research projects aimed at driving innovation to shape chemical risk assessment methodologies and regulatory guidance. We are recognised for our higher tier risk assessments, particularly in areas concerning environmental fate and ecotoxicology. In the complex landscape of EU and UK/GB chemical legislation, our experts guide businesses towards pragmatic solutions for achieving regulatory compliance in a responsible manner. Enviresearch is an associate member of CropLifeUK and member of the UK Agri-Tech Centre, CHAP (Crop Protection & Health) network. As part of the RSK group of companies, Enviresearch contributes to the broader range of environmental, engineering and technical services delivered by businesses across the group. For more information about Enviresearch and the services we offer, visit www.enviresearch.com or contact us at info@enviresearch.com.

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