Requirements :
1.Provide regulatory consultation for clinical projects or stand-alone regulatory projects
2.Preview regulatory documentation to approve initiation of clinical trials and/or shipment of clinical trial supplies
3. Prepare and submit regulatory documents in support of clinical trials
4. Assist in clinical development activities
5. Prepare and/or review scientific technical documents for regulatory adequacy and compliance with appropriate regulatory guidelines
6. Coordinate documentation practices in order to promote efficient compliance with regulatory requirements
7. Maintain proficiency in current knowledge of all applicable regulatory guidelines and regulations
8. Supervise junior regulatory affairs staff
Requirements
You will be educated to a Bachelor?s level degree in life sciences, pharmacy or a suitable equivalent qualification
Demonstrate regulatory affairs experience of at least 10 years gained in either Pharmaceutical, Biotechnological or Clinical Research organisations.
Recent experience of clinical trials applications (CTA?s) to Ethics Committees
You will also need to be fluent in German and English both written and spoken.
The company has been growing and they need a line manager to manage a team and advise on all their regulatory affairs projects. They can offer great career opportunity and world wide variety of project.
Please send your CV to beata.klecz@secpharma.com or call on 0044 207 2556665
SEC Recruitment Limited is acting as an Employment Agency and/or Employment Business