Clinical Trial Regulatory Affairs Expert (Fixed term)
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Job Location:
Monthly Salary:
Posted on:
19 hours ago
Vacancies:
1 Vacancy
Job Summary
At Roche you can show up as yourself embraced for the unique qualities you bring. Our culture encourages personal expression open dialogue and genuine connections where you are valued accepted and respected for who you are allowing you to thrive both personally and professionally. This is how we aim to prevent stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche where every voice matters.
The Position
The Opportunity
Position summary: Following a 46 month mentorship period the candidate will assume the role of strategic architect for the CTA process across the EEA and this capacity the CTA Regulatory Expert holds primary responsibility for the strategic oversight of clinical trial regulatory activities. Working in close partnership with Regulatory Programme Managers (EU Partner/GRL) the CTA Regulatory Expert owns the regulatory framework and drives its execution leveraging cross-functional support to ensure the delivery of global milestones.
This is a one year Fixed term position were you will be focusing on:
Management of Core CTAs or common documents and amendments for EEA and ROW countries: planning compilation dispatch coordination with internal departments and the affiliates tracking of submissions and approvals in appropriate systems
Attend key SMT/RAFT meetings (in the planning phase of a clinical trial and further as appropriate) in agreement with the Program Managers
Interact with various stakeholders for specific CTA related activities
Support clinical trials in international countries on the need basis in collaboration with the Program Manager
Work with the senior Clinical Trial Regulatory Affairs Expert or the group manager on various activities like knowledge sharing and maintenance of the information.
Advise Program Managers on external and internal requirements for CTAs as well as country specific changes based on the experience
Who you are:
At least 1 year experience working on the clinical trial related activities
BS/BA degree or minimum 3 years relevant experience in pharmaceutical Industry
Excellent planning and organizational skills and communication skills
Ability to work in a team-based customer focused environment
Ability to coordinate multiple activities in parallel
Fluent in written and spoken English
Any regulatory knowledge/experience will be of advantage (especially experience with Veeva RIM and CTIS).
Teamwork: works effectively as a team member in a cross-functional team
Planning Coordination and Organization: possesses excellent administrative and project planning skills; pays attention to details and demonstrates commitment to deliver high quality work; commits to agreed timelines; is able to work under stress.
In Exchange we provide you with:
Development opportunities: Roche is rich in learning resources. We provide constant development opportunities free language courses & training the possibility of international assignments internal position changes and the chance to shape your own career.
Excellent benefits & flexibility: Roche Annual Bonus Monthly transportation allowance Home Office set - up equipment Health Insurance Life/Accident insurance Full salary when on sick leave for the first 9 days Eyeglasses settlement One-time payment options for various events in the life e.g. wedding childbirth Service Awards: We value loyalty with additional holidays and bonus payment Work in a hybrid model (2 days/week from the office)
A global diverse community where we learn from each other. At Roche we cooperate debate make decisions celebrate successes and have fun as a team. Our leadership is very focused on people creating a strong inclusive culture so you always have the chance to share your opinion.
Salary starts from 2700 EUR gross/monthly. Final salary depends on the successful candidates level of experience skills and qualifications.
Who we are
A healthier future drives us to innovate. Together more than 100000 employees across the globe are dedicated to advance science ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities foster creativity and keep our ambitions high so we can deliver life-changing healthcare solutions that make a global impact.
Lets build a healthier future together.
Roche is an Equal Opportunity Employer.
Key Skills
- Proofreading
- Adobe Acrobat
- FDA Regulations
- Manufacturing & Controls
- Biotechnology
- Clinical Trials
- Research & Development
- GLP
- cGMP
- Product Development
- Chemistry
- Writing Skills
About Company
F. Hoffmann-La Roche AG is a Swiss multinational healthcare company that operates worldwide under two divisions: Pharmaceuticals and Diagnostics. Its holding company, Roche Holding AG, has bearer shares listed on the SIX Swiss Exchange. The company headquarters are located in Basel.
