Regulatory Associate
- Recruiter
- Confidential
- Location
- Ware
- Salary
- Competitive
- Posted
- 20 Feb 2021
- Closes
- 20 Mar 2021
- Sectors
- Health, Nursing & Social Care
- Contract Type
- Contract
- Hours
- Full Time
CY Partners have a fantastic opportunity for anyone looking to begin a career within regulatory affairs. It is based with a global pharmaceutical organisation, initially home based with a view to working from the office a few days a week 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 for a confidential chat about the role or you can submit your CV to apply.
The recruiter has stated that all applicants for this job should be able to prove that they are legally entitled to work in the UK. CY Partners Recruitment Ltd, trading as CY Partners is an Employment Business/Agency
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 for a confidential chat about the role or you can submit your CV to apply.
The recruiter has stated that all applicants for this job should be able to prove that they are legally entitled to work in the UK. CY Partners Recruitment Ltd, trading as CY Partners is an Employment Business/Agency