Pfizer Clinical Research Regulatory Associate in Brussels, Belgium
The Pfizer Clinical Research Units in Belgium, Anderlecht and US, New Haven are the state-of-the-art Clinical Research Units (CRU's) of Pfizer Worldwide Research and Development.
In these CRU's, predominantly phase 1 trials are run, with subjects protection and permanent quality as paramount.
The clinical trials, with the help of healthy volunteers and patients, are key in the development of new medicines which will help patients worldwide.
The studies run in the PCRU are set up in collaboration with US and UK Study Teams, based on the most accurate protocols.
The Regulatory department within the PCRU is responsible for preparing and filing the Clinical Trial Applications to both FAMHP and Ethics Committees. It also ensures quality documentation of trials and inspection readiness for studies.
Currently, we have a vacancy for a
Clinical Research Regulatory Associate
Purpose of the role
The Regulatory Associate:
Provides support for all activities related to the submissions to Ethics Committee(s) and Regulatory Authorities.
Adds value to the business and ensures compliance by providing logistic and administrative support to the Regulatory Department and to the Regulatory Affairs Manager by contributing to the preparation, follow-up, processing, implementation and electronic archiving of all regulatory submissions and activities, in order to meet regulatory requirements, internal standards and procedures and optimize the achievement of the global objectives.
Provides input / take initiative and follow-up all activities for timely and proper completion of required activities.
Provide support to ensure timely and accurate submission of CTAs (Clinical Trial Applications) to the ethics committee(s) (EC) & competent authorities (CA).
Provide support within the Regulatory Team to ensure that studies are conducted scientifically and ethically and in compliance with MEA/FDA/ICH/GCP guidance and regulation.
Support the ICDs management and their translations.
Ensure that all local and global systems, tracking tools and databases are continuously and accurately updated with regulatory informations. Develop processes for and coordinate ad hoc and routine QC checking of regulatory databases and systems and build expertise through management of operational processes and regulatory databases/systems;
In compliance with applicable local and corporate SOPs and best practices, manage and complete all regulatory systems in collaboration with Regulatory Affairs colleagues, by checking events and regulatory and submissions-related activities;
Provide the administrative work related to completion of trials (CSR, ASR, SUSAR, AE, etc.), communications to CA and EC;
Ensure end of study reports are provided in time to CA & EC;
Act as super-user and system owner for defined regulatory databases/systems, and manage business activities for assigned regulatory system development projects on behalf of the PCRU Regulatory team;
May provide support to the management of trials when appropriate, and maintain accuracy, accessibility, and confidentiality in volunteer records and reports when doing so;
Provide support to the project teams for studies scheduled in the PCRU;
Support the implementation of new processes and work to proactively resolve issues where appropriate;
Manages the maintenance and archiving of all clinical trial regulatory documents and study files;
Supports the audit and inspection visit preparations;
General administrative work:
- Provide support and back-up for administrative tasks as needed
Participate in training courses as appropriate;
Assist in the training of PCRU staff and contractors with less experience and expertise;
Responsible for complying with Pfizer Standards, ethical standards, ICH, regulatory and legal requirements, national and European laws on health and safety at work, fire prevention and other appropriate legislation.
Profile we are looking for
Minimum level of education:
- Bachelor degree in (Medical) Secretarial Assistant, Life Sciences or equivalent, with relevant experience in Regulatory Affairs.
Functional / Professional Competencies Specific to the job:
Detail oriented, precise in oral and written communication
Strong administrative orientation
Autonomous but with a strong team spirit,
Strong organizational skills, multiple projects flexibility
Very keen sense of initiative,
Very good resistance to stress and a high workload.
Strong IT skills: advanced use of Outlook, Word, Excel and PowerPoint.
Min. 5 years of experience in the field of administration, secretarial work or office management, of which at least some years in a regulatory environment
Languages : French, Dutch and English (written and spoken)
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.