Senior Toxicologist – Regulatory & Non-Clinical Development
A specialist life sciences organisation is seeking an experienced Toxicologist to provide senior-level scientific and regulatory toxicology expertise across biologics, vaccines and advanced therapy programmes.
This role sits at the intersection of science and regulation — supporting global development strategies, overseeing GLP studies, and contributing directly to IND, CTA, MAA and NDA submissions.
The Role
You will provide strategic toxicology input across the non-clinical development lifecycle, acting as a senior advisor to cross-functional teams and clients.
Key responsibilities include:
* Providing expert toxicology strategy across biologics, vaccines and ATMP programmes
* Designing, placing and overseeing GLP toxicology studies at CROs (e.g. repeat-dose, DART, genotoxicity)
* Monitoring study conduct, reviewing protocols and interpreting data
* Preparing and contributing to non-clinical toxicology sections of global regulatory submissions (CTD format)
* Supporting interactions with EMA, FDA, MHRA and other international authorities
* Conducting safety evaluations of extractables & leachables (E&L), process residuals, contaminants and novel excipients
* Developing toxicological risk assessments (PDE, NOAEL, OEL, TTC) and weight-of-evidence reviews
* Acting as a subject matter expert in regulatory toxicology, including REACH, CLP and ICH guidance
* Participating in safety committees and cross-functional development teams
This is a visible role with meaningful regulatory influence across multiple development programmes.
What We’re Looking For
You will bring:
* An advanced degree in toxicology (or closely related discipline)
* Strong experience in regulatory toxicology within a biopharmaceutical or consultancy setting
* Hands-on experience overseeing GLP toxicology studies via CROs
* Experience contributing to IND/CTA/MAA/NDA submissions
* Confidence engaging with global regulatory authorities
* The ability to communicate complex toxicological concepts to multidisciplinary stakeholders
Experience across biologics, vaccines or advanced therapies is particularly valuable.
Why Consider This Opportunity?
* Broad exposure across innovative biologics and advanced therapies
* Direct regulatory impact at global level
* Senior advisory remit with scientific autonomy
* Collaborative environment working across regulatory, manufacturing and development functions
This role would suit a Toxicologist operating at Senior Manager / Associate Director level who enjoys strategic advisory input alongside hands-on regulatory contribution.