Regulatory Submissions Coordinator
A global Clinical Research Organisation (CRO) is advertising a vacancy for a Regulatory Submissions Coordinator position. The company provides Phase I-IV clinical development services to the biotechnology, pharmaceutical, and medical device industries by accelerating the global development of safe and effective medical therapies through its high-science and disciplined operating approach. Based in either the company's Russian office, this is an exciting opportunity to work for an international company and bolster a career in the clinical field.
- Prepare, review, and file clinical trial applications to domestic and international regulatory agencies.
- Ensure submissions comply with applicable regulations and guidance documents.
- Advise sponsors on changing regulations and compliance requirements.
- Track submissions and ensure timely filing of documents.
Skills and Requirements:
- Bachelor's degree in life sciences.
- Previous experience as a Regulatory Submissions Coordinator in a Clinical Research setting.
- Hands-on experience preparing, reviewing, and submitting regulatory documentation.
- Demonstrable multitasking, project management, and execution skills.
- Good interpersonal skills, including communication, presentation, persuasion, and influence.
- Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
- 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 Polina Sidorova at firstname.lastname@example.org or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
Proclinical Staffing is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.
A vacancy has arisen for a Regulatory Affairs Publisher with an internationally renowned biotechnology company, based in their office in the UK.