DirecciónWhat you will do
Liaise with colleagues to plan, organize, compile, progress, track and submit regulatory submissions on a timely basis.
Where required provide local QC of submission dossiers prior to dispatch
- May act as a contact point for translation review of submissions documents such as application, synopsis, ICF, labels etc.
- Effectively communicate to the Lead and relevant project team members the status and action plans concerning submissions and advise the project team about appropriate regulatory strategies
- Review and make recommendations on all relevant documentation e.g. labels, patient information sheets, diary cards etc.
to comply with ICH GCP & country specific requirements
What you will bring to the role
- Strong organizational and management skills
- Self-motivated learning about current regulatory processes and intelligence
- Excellent written and verbal communication skills to clearly and concisely present information
- Team-oriented work style; seeks and gives guidance to others
- Strong interpersonal skills in a fast-paced, deadline oriented, and changing environment
- Excellent ability to handle multiple tasks in a fast-paced and changing environment
Your background
- A minimum four-year college curriculum with a major concentration in medical, biological, physical, health, pharmacy or other related science
- Minimum one year of experience in clinical research, in regulatory-related function
- Good knowledge of ICH GCP, EU Clinical Trials Directive and other relevant clinical research conduct guidance
- Multilingualism preferred; fluent in local language; working knowledge of English
We love knowing that someone is going to have a better life because of the work we do.
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