Jobs in Winchester, United Kingdom

Freelance Non-Clinical Expert (EU/UK-Based)

We are seeking an experienced freelance Non-Clinical Expert to act as a regulatory signatory for non-clinical overviews in the EU/UK. The ideal candidate will be capable of reviewing and signing non-clinical reports and non-clinical summaries, ensuring compliance with EU regulatory standards.

Key Responsibilities:

1. Review and sign non-clinical toxicology reports and non-clinical summaries for regulatory submissions.
2. Ensure compliance with EU regulatory requirements, including EMA guidelines, ICH M3, and GLP principles.
3. Provide expert toxicological assessments and risk evaluations for pharmaceutical and biotechnology products.
4. Work collaboratively with regulatory teams to ensure high-quality non-clinical documentation.
5. Offer strategic advice on non-clinical toxicology aspects to support product development.

Requirements:

1. Advanced degree in Toxicology, Pharmacology, Biomedical Sciences, or a related field.
2. Significant experience in non-clinical toxicology and regulatory toxicology.
3. Familiarity with EU regulatory requirements, including EMA guidelines and ICH M3.
4. Experience in Good Laboratory Practice (GLP) studies and regulatory submissions.
5. Ability to provide legally recognized expert signatory services for non-clinical toxicology documents and summary sign offs.
6. Strong analytical and communication skills.

Preferred Qualifications:

1. EU-registered toxicologist (such as ERT certification) or equivalent accreditation.
2. Experience with pharmaceutical, biotech non-clinical works.
3. Prior experience working with freelance or consultancy-based toxicology assessments.

Job Type:

Freelance/Contract-Based

Remote work with flexibility