Regulatory Compliance Coordinator, Belgium - L
- Experience Level
- Experienced (non-manager)
CROMSOURCE, the international and ISO Certified CRO, is currently looking for a Regulatory Compliance Coordinator in Brussels area, to join the ranks of our sponsor and support Regulatory Department while fostering strong, productive relationships with colleagues across the organization . This is an opportunity open to freelancers.
Position Duties & Responsibilities:
- Responsible for the maintenance of regulatory databases, trackers and systems
- Assists with preparing the necessary documents, outlines and application forms for initial clinical study regulatory submissions, amendments, and closure of study packages in compliance with country regulatory requirements
- Prepares Departmental meetings and audits (logistics, formatting)
- Coordination of training into the Learning Management System
- Acts as Records Management Coordinator, ensuring record retention policy and procedures are implemented
- Fulfills products release requests in accordance with Regulatory requirements (Item restriction Process)
- Provides operational support for affiliates requests
- Assists in the development of best practices for Regulatory Affairs processes
Education, Experience and Skills:
- 4-6 years of work experience, preferably but not limited to regulatory affairs
- High school diploma
- Excellent written and verbal communication skills in English
- Creative and good computer skills: Outlook, Power Point, One Note, Excel,
- Detail oriented, conscientious,
- Ability to take on diverse tasks,
- Good organizational skills
- Capacity to work in and with a diverse team
Who will you be working for?
CROMSOURCE is a family owned international, full-service Contract Research Organisation who, since 1994, has been supporting our clients with outstanding clinical research and staffing solutions services. The successful growth of CROMSOURCE has been achieved by putting high quality and client focus at the heart of everything we do.
Our Company Ethos
Our employees are the most valuable company asset. We value our resources and ensure they work in a friendly, family environment so they are able to develop their skills and talents. Human Resources is the fulcrum around which all CROMSOURCE activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives to all personnel the clear tools needed to manage both internal and client processes with the same methodology. The success of these core values are evidenced by our below industry average turnover rates.
About TalentSource Life Sciences
TalentSource is the division of CROMSOURCE dedicated to flexible staffing solutions. Through us, you will have the opportunity to be integrated into a sponsor-led team, whilst having the continuous support from your Line Manager, who will work closely with you to mentor and support your professional development and growth. For our client-facing positions, you must be confident, be able to drive the role and work autonomously.
The Application Process
Once you have submitted your CV, you will receive an acknowledgement that we received it. If you have the requirements we need, you will be invited for phone interview as the first step. Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful.
If you would like to discuss the role before applying through the website @ https://www.talentsourcelifesciences.com/job-information/?job-id=HQ00002474
or please contact Vanessa.Verdickt@cromsource.com for more information.
CROMSOURCE is an equal opportunities employer. All qualified applicants will receive consideration for employment in relation to race, colour, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran or military status or any other legally protected status. CROMSOURCE is also committed to compliance with all fair employment practices regarding citizenship and immigration status.
Keywords: Regulatory Compliance Coordinator
Skills: Freelance, MS Office, Pharma, Pharmaceutical, Regulatory Location: Belgium Share:
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