We want to expand our team and we are looking for a freelance Regulatory Affairs Specialist Timisoara.
This position is responsible for knowledge and experience with global (country/local) regulatory and legal requirements related to site activation activities; develop and approve processes in collaboration with other departments.
We are looking for someone who demonstrates:
- Intense collaboration;
- Passionate customer focus;
- Tenacious commitment to continuous improvement;
- Relentless drive to win.
Here is a glimpse of what you’ll do:
- Oversee the development, implementation and adherence to site activation project plans and performance indicators.
- Ensure consistency in operational and financial delivery within assigned therapeutic area.
- May contribute to the development and review of site activation-related SOPs and other Quality Management Documents.
- Liaise with Clinical Monitoring, Site Contracts, Regulatory Affairs, other interdepartmental team members and sponsors to enable a rapid clinical trial start-up.
- Coordinate the development of the feasibility questionnaire for a study. Seeks expertise from applicable supporting functions (CTM, Medical, PM, Contracts, Regulatory, etc.), and finalizes draft for Sponsor review, as required. Works with PM to obtain client approval of the study specific feasibility questionnaire, as needed.
- May act as a contact point for translation review of submissions documents such as application, synopsis, ICF, labels etc.
- Provide local QC of submission dossiers prior to dispatch.
- 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.
- A Bachelor’s degree or equivalent in Medicine, Pharmacy or Engineering (Organic Chemistry, Biochemistry, Biotechnology)
- Advanced knowledge of the English language. Other languages represent an advantage
- At least 1-3 years experience in a similar job
- Good knowledge of Microsoft Office applications
- Valid B category driver’s license preferred
- Willing to travel for professional purposes.
- Good understanding and knowledge of Good Clinical Practice and clinical trial operation processes/procedures.
What we offer:
- A dynamic working environment in a growing international company;
- Opportunity for professional development.
- A culture of mutual respect and an outstanding working environment.