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- Tasks: Review and sign non-clinical toxicology reports for regulatory submissions.
- Company: Join a leading consultancy in the pharmaceutical and biotech sectors.
- Benefits: Flexible remote work, competitive pay, and the chance to shape product development.
- Why this job: Make a real impact in regulatory compliance and support innovative health solutions.
- Qualifications: Advanced degree in Toxicology or related field with significant experience.
- Other info: Enjoy a freelance lifestyle with opportunities for professional growth.
The predicted salary is between 36000 - 60000 £ per year.
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:
- Review and sign non-clinical toxicology reports and non-clinical summaries for regulatory submissions.
- Ensure compliance with EU regulatory requirements, including EMA guidelines, ICH M3, and GLP principles.
- Provide expert toxicological assessments and risk evaluations for pharmaceutical and biotechnology products.
- Work collaboratively with regulatory teams to ensure high-quality non-clinical documentation.
- Offer strategic advice on non-clinical toxicology aspects to support product development.
Requirements:
- Advanced degree in Toxicology, Pharmacology, Biomedical Sciences, or a related field.
- Significant experience in non-clinical toxicology and regulatory toxicology.
- Familiarity with EU regulatory requirements, including EMA guidelines and ICH M3.
- Experience in Good Laboratory Practice (GLP) studies and regulatory submissions.
- Ability to provide legally recognized expert signatory services for non-clinical toxicology documents and summary sign offs.
- Strong analytical and communication skills.
Preferred Qualifications:
- EU-registered toxicologist (such as ERT certification) or equivalent accreditation.
- Experience with pharmaceutical, biotech non-clinical works
- Prior experience working with freelance or consultancy-based toxicology assessments.
Job Type:
Freelance/Contract-Based
Remote work with flexibility
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Non-Clinical Expert/Signatory employer: Coronado Research
Contact Detail:
Coronado Research Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Non-Clinical Expert/Signatory
✨Tip Number 1
Network like a pro! Reach out to your connections in the toxicology and regulatory fields. Attend relevant webinars or conferences to meet potential collaborators and clients. Remember, it’s all about who you know!
✨Tip Number 2
Showcase your expertise! Create a portfolio that highlights your previous non-clinical reports and summaries. This will not only demonstrate your skills but also give potential clients confidence in your abilities.
✨Tip Number 3
Stay updated on regulations! Make sure you’re familiar with the latest EU guidelines and ICH M3 standards. This knowledge will set you apart as a reliable signatory and help you provide strategic advice effectively.
✨Tip Number 4
Apply through our website! We’ve got a streamlined process that makes it easy for you to submit your interest. Plus, we love seeing candidates who take the initiative to connect directly with us.
We think you need these skills to ace Non-Clinical Expert/Signatory
Some tips for your application 🫡
Tailor Your Application: Make sure to customise your CV and cover letter to highlight your experience in non-clinical toxicology and regulatory compliance. We want to see how your background aligns with the key responsibilities outlined in the job description.
Showcase Your Expertise: Don’t hold back on showcasing your qualifications! Mention your advanced degree and any relevant certifications, like ERT. We’re looking for someone who can provide expert assessments, so let us know what makes you the right fit.
Be Clear and Concise: When writing your application, keep it clear and to the point. Use straightforward language to describe your experience with EU regulatory requirements and GLP principles. We appreciate clarity as much as expertise!
Apply Through Our Website: We encourage you to apply directly through our website. It’s the best way for us to receive your application and ensures you don’t miss out on any important updates during the process. We can’t wait to hear from you!
How to prepare for a job interview at Coronado Research
✨Know Your Regulations
Make sure you brush up on EU regulatory standards, especially EMA guidelines and ICH M3. Being able to discuss these in detail will show that you’re not just familiar with the requirements but can also apply them in practice.
✨Showcase Your Expertise
Prepare to discuss your previous experience in non-clinical toxicology and how it relates to the role. Bring specific examples of reports you've reviewed or signed off on, and be ready to explain your thought process behind those decisions.
✨Collaborative Spirit
Since the role involves working with regulatory teams, highlight your ability to collaborate effectively. Share examples of how you’ve worked with others to ensure high-quality documentation and compliance in past projects.
✨Ask Insightful Questions
Prepare thoughtful questions about the company’s approach to non-clinical assessments and their expectations for the role. This shows your genuine interest and helps you gauge if the company is the right fit for you.