My client is looking to extend their Ethics and Regulatory department in Germany and are seeking an experienced Manager Study Start Up & Regulatory. The role is an absolutely pivotal role and comes with vast amounts of opportunities for learning and development. You will be required to ensure the continuous improvement of quality of all Regulatory and Start-up components at the project level across Europe.
Your duties as a Manager, Study Start Up & Regulatory will include the following:
Assisting senior managers, managing work and teams within a specific or broad area of site start-up, such as site activation, regulatory, submissions, site contracts, or regulatory records.
- Line Management
- Ensuring fulfillment of customer requirements and compliance with related regulations.
- Analysing processes and developing strategies to increase efficiency.
- Performing operational level planning, including efficient allocation of resources within the department.
- Participating in business development presentations as a subject matter expert in Site Start-Up & Regulatory functions within the Company.
To succeed in this role you will need the following skills/experience:
- Education to university degree level in pharmacy, medicine or related natural sciences
- Strong experience, including previous experience in Regulatory or Start-up functions ideally on a global level
- Hands-on experience in the submission of clinical trial applications
- Ability to multitask and work effectively in a fast-paced environment with changing priorities
- Maintains a positive, results orientated work environment
- Ability to read, write, and speak fluent English
If you are looking for a career within a transparent and non-hierarchical organisation then please contact me on +49 69 274 015 840 or via email with your CV firstname.lastname@example.org.