Non-Clinical Manager (remote-based)
Hobson Prior are in search for a talented Non-Clinical Manager to join a pioneering biotech organisation where you will be based within the Pharmacology and Toxicology function. This role is a permanent position and will require to work remotely and one day in the office.
Please note that to be considered for this role you must have the right to work in this location.
- You will be authoring of non-clinical components of regulatory documents to support CTAs and INDs, including, but not limited to investigator brochures, scientific advice briefing documents, IND modules 2 and 4 and also BLA/MAA.
- Accountable to formulate responses to nonclinical regulatory questions for CTAs/INDs.
- Provide input to regulatory submission plans, timelines, regulatory document content and dependencies.
- Partake in discussions with Regulatory Authorities worldwide in all matters relating to nonclinical development.
- To ensure that nonclinical deliverables are in accordance with regulations, standards, and guidelines.
- Work collaboratively with outsourced non-clinical writing activities as needed.
- Robust oral and written communication skills.
- Collaborative working style with ability to partner across the organisation.
- Self-motivated and able to work self-sufficiently.
- Strong organisational skills.
- Excellent understanding of the concepts and applications of non-clinical research and other disciplines involved in drug development.
- Result driven with the ability to demonstrate time management and project planning.
- Project management experience and multi-tasking skills.
- A Bachelor's degree or equivalent in the Life Sciences as a minimum.
- Proven track record in writing and reviewing non-clinical and regulatory documents including, but not limited to regulatory study reports, Investigator Brochures, Scientific Advice briefing documents, non-clinical content of IND modules 2 and 4, and BLA/MAA.
- Advanced working knowledge of MS Word, EndNote, review tools.
- Experience with worldwide nonclinical regulatory requirements for safety testing and effective influencing and negotiating with regulatory agencies, agency meetings, industry bodies, and internal customers.
- Experience in formulating responses to nonclinical regulatory questions for CTAs/INDs, MAA/NDAs.
- Experience of working with gene therapy projects would be desirable.
If you are interested in learning more or applying to this exciting opportunity then please click "Apply" and upload a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist directly, please select "Contact me" at the top of this page.
Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.
$140000 - $150000 per annum
We currently have an excellent opportunity for a talented RA Senior Manager to work on a diverse and complex portfolio and execute on creative regulatory strategies.