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Regulatory Associate

Regulatory Associate

Belgium - Anderlecht

Pfizer is the world's premier biopharmaceutical company taking new approaches to better health. We discover, develop, manufacture and deliver quality, safe and effective prescription medicines to treat and help prevent disease for people. We also partner with healthcare providers, governments and local communities around the world to expand access to our medicines and to provide better quality health care and health system support. At Pfizer, colleagues in more than 90 countries work every day to help people stay happier and healthier longer and to reduce the human and economic burden of disease worldwide.

Our Pfizer Clinical Research Unit (PCRU) in Brussels is a state-of-the-art research facility with sixty inpatient beds dedicated to early clinical trials (Phase 1 & 2a studies).

The Regulatory Associate:
* is providing 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 and External Relations 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.
* Provide input / take initiative and follow-up all activities for timely and proper completion of required activities.

JOB RESPONSIBILITIES
* 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 EMEA/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 information. 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;
Other
* 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 study files;
* Supports the audit and inspection visit preparations;

General administrative work:
* Provide support and back-up for administrative tasks as needed Training
* 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.

QUALIFICATIONS / SKILLS
* Bachelor degree in Management/(Medical) Secretarial Assistant, Life Sciences or equivalent, with relevant experience in Regulatory Affairs
* 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
* Autonomous with a strong team spirit
* Service-minded, accountable
* Strong administrative orientation
* Strong organizational skills, multiple projects flexibility
* Detail oriented, precise in oral and written communication
* 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
* Languages : Fluent in French, Dutch and English (written and spoken)

WHAT WE OFFER

In addition to competitive salaries and customized benefits packages, we offer a supportive and diverse culture and unparalleled career development opportunities.

We offer you a challenging job in an international and complex environment within a dynamic team.

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.

#LI-PFE

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.

Posted Today

Full time

4762098

Regulatory Associate

Pfizer, Anderlecht
Contract Type: 
Permanent contract
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