Regulatory Affairs Officer
A leading Pharmaceutical company, committed to accelerating the development of new drugs for patients around the world, is currently recruiting a Regulatory Affairs Officer. This is an exciting opportunity to bring expertise and skills to an established and in-demand company.
- Review of documentation to include Clinical Protocols and Investigator Brochures to ensure compliance with applicable regulatory requirements necessary for submission.
- Author Clinical Trial Application forms and covering letters for the regulatory submission package.
- Compile and submit Clinical Trial Authorisation application packages to the MHRA.
- Review and compile Research Ethics Application packages, where applicable.
- Author, review and compile Administration of Radioactive Substances Advisory Committee (ARSAC) submission packages where required (experience not essential as full training will be provided).
- Author, review and compile substantial amendment documentation where required.
- Perform maintenance activities throughout the lifecycle of the clinical study.
- Contact and liaise with the regulatory agencies as required.
Skills and Requirements:
- A minimum degree level in a biological or life science discipline.
- Previous relevant regulatory experience in a pharmaceutical company or CRO is essential.
- Theoretical and practical understanding of regulations and guidance with the ability to analyse and apply knowledge where required.
- Proven team work ability.
- Ability to work on multiple tasks simultaneously and manage time successfully.
- Ability to work to strict deadlines.
- Excellent attention to detail.
- Confident and articulate communicator (both written and verbal), with the ability to convey and present information to others clearly and logically.
- Customer focused and an ability to respond to sponsor requirements in a timely manner.
- Demonstrable multitasking, project management, and execution skills.
- Good interpersonal skills, including presentation and persuasion.
- Good organisational skills, including efficiency, punctuality, and collaboration in a team
- Proficiency with computer skills, such as MS Office.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please contact Will Hitchcock at 0203 078 9554 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.