Regulatory Affairs SSU Specialist (m/f/d)
Regulatory Affairs SSU Specialist (m/f/d)
Über CTI Clinical Trial & Consulting Service Europe GmbH
The origin of the name
CTI was founded more than 22 years ago as the "Cincinnati Transplant Institute." Within a year, it was clear that name didn't encompass our rapidly-growing expertise in adjacent therapeutic areas, like immunology, rare disease, and pediatric programs. The name was quickly changed to "CTI Clinical Trial & Consulting."
Consistent, significant growth
Now in our 3rd decade, CTI has grown consistently and significantly, becoming a global organization with associates in more than 60 countries across the world. We have worked on more than 10,000 projects, worked on every continent except Antarctica, and have contributed to more than 150 new drug and device approvals through global regulatory agencies such as the FDA, EMA, and others. Currently, we work with approximately 250 pharmaceutical and emerging biotechnology and medical device companies.
Your Tasks
- You assist/advise project teams on all regulatory requirements for clinical studies
- You perform compliance assessments according to country requirements and document any activity discovered
- You review and adapt study specific documents according each country and site requirements
- You interact with site personnel, CPCs, CRAs and PMs, for document corrections, clarification or resolution of any incorrect documentation
- You prepare and check Clinical Trial Application forms (e.g. CTA, XML), where applicable
- You interact with Sponsors as needed; forward regulatory documentation, including final regulatory submission packages
- You compiling and assessing completeness of the Regulatory-Package for drug release (Regulatory Document Study Start Up Checklist)
- You provide Project teams with accurate periodic status reports and attend internal and external project meetings as needed
- You oversee translation of regulatory documents, if needed, on behalf of Sponsor, as agreed to in scope
Your Profile
- You have a Bachelor’s Degree in allied health field such as nursing, pharmacy or health science or the equivalent relevant experience
- You have a minimum of 1 - 2 years of relevant pharmaceutical, site, or CRO Regulatory experience
- You posses the ability to provide superior level of customer service, develop, prioritize, organize, and manage multiple tasks
- You are great at problem solving and decision making
- You love to collaborate with a team
- You are proficient in the use of computer and software systems
- You have great written and oral skills in German and English
Our Benefits
- We support career progression
- We believe in promoting from within and we have a structured mentoring program and program for recent graduates
- We provide tuition assistance, partner with universities and colleges to create programs in our field, and have a dedicated training department
- We support a work-life balance and the importance of time with family by offering generous vacation and a hybrid work schedule
- We've received multiple awards recognizing us as one of the best places to work in the industry
- We think globally, but act locally – With employees across 60 countries, we have global reach but maintain culture and connections
- We have had a consistent double-digit growth rate over the last decade
- We invest in cutting-edge technology, and pride ourselves on our average annual retention rate of 95%, which is much higher than many other CROs
- Our work makes a difference – We focus our work on treatments for chronically and critically-ill patients, who are depending on us
Zur Bewerbung:
Unser Jobangebot Regulatory Affairs SSU Specialist (m/f/d) klingt vielversprechend? Dann freuen wir uns auf eine aussagekräftige Bewerbung unter: https://cti-clinical-trial-consulting-service-europe.workwise.io/s/Yvbnn7g-regulatory-affairs-ssu-specialist-mfd