Life Sciences Pharmaceuticals
CY Partners have a fantastic opportunity for anyone looking to begin a career within regulatory affairs. It is based with a global pharmaceutical organisation at their site in Hertfordshire.
Within this role as Regulatory Associate, you will assist in the preparation of nonclinical regulatory dossiers including: Global CTD dossiers for Marketed Products and Clinical Trial Applications.
Responsibilities will include:
- Data mining and compilation of nonclinical study reports from legacy submissions and company archives
- Updates to specific nonclinical CTD components from existing submission documentation.
- Comprehensive literature/information searches both externally and internally.
- Where necessary, technical authoring of new CTD components to support in‑licensed/collaborative products.
- Generation of nonclinical submission components to support established pharmaceutical products eg Label unification, ad hoc requests for information.
- Collaboration with nonclinical development and regulatory content delivery departments Clinical Trial Applications.
Requirements for the role include:
- A relevant biologically based scientific background/ experience.
- Understanding of the nonclinical content related to in vivo and in vitro testing: ie pharmacology, pharmacokinetics & toxicology related to drug development.
- Excellent written and verbal communication skills, computer literate and competent in the use of Microsoft Word and Excel.
- Proficiency in searching on-line scientific publication databases.
- Knowledge of nonclinical regulatory requirements [e.g., Common Technical Document (CTD) guidelines] would be preferable but not essential.
This role is offered on an initial 12-month contract basis and is an excellent opportunity for anyone wanting to develop a career in regulatory affairs, it is a fantastic entry into industry with excellent training opportunities.
If you are interested, please get in touch with Helen Tomlinson at CY Partners 07851246847 for a confidential chat about the role or you can submit your CV to: [email protected]