We are looking for a multitalented Clinical Regulatory Manager with excellent social skills to join the team in managing the (inter)national clinical regulatory and EC submission and approval process within a clinical trial. We work on a variety of (international) projects and for diverse types of customers (e.a. pharma companies, biotech etc.)
As part of our driven Regulatory team (3 FTE), you will directly report to our Manager Regulatory.
- Act as a liaison between the review committees, regulatory agencies, Local Partners, vendors and the client to ensure that protocols are approved, and that supplementary information is provided in a timely manner as requested;
- Create a regulatory and EC submission and approval plan at the start of a project;
- Create and maintain a database with up-to-date information on ongoing and completed trials;
- Ensure (local) activities are undertaken in accordance with agreed timelines, allocated budgets, and required quality standards;
- Perform progress reporting to stakeholders;
- Identify and assess regulatory risks and related project issues and makes recommendations to stakeholders;
- Assure compliance of general and study-specific regulatory processes with (inter)national law and regulations;
- Gain and maintain knowledge of (inter)national clinical regulatory legislation and requirements.
- Higher level of education, preferable in pharmacy or life sciences;
- 5 years of experience in Clinical Trials;
- 2 or 3 years’ experience within the Regulatory work field / submissions (preferably with European and/or international submissions);
- Extensive knowledge of EU Clinical Trial Directive and respective guidance documents as well as ICH guidelines and international submission regulations and procedures;
- Knowledge of Medical Devices regulations is preferable;
- Skills: communicative, stress resistant, overview, multitasking, leadership.
ORGANISATION AND OFFER
An open culture in an innovative and dynamic environment with inspiring colleagues and good working conditions. An environment where you have room to be creative, take initiative and have direct influence on the way we work.
After COVID we intend to offer the option of working from home, working at the office or a combination of the two.
INTERESTED? Reach out to Harun Noorzai for more information by contacting +31 (0)20 20 44 502 or email@example.com