Regulatory Coordinator, Belgium - L

Employer
CROMSOURCE
Location
Belgium
Salary
Competitive
Closing date
3 Oct 2020

View more

Discipline
Regulatory Affairs
Hours
Full Time
Contract Type
Permanent
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Description:
TalentSource Life Sciences, the division of CROMSOURCE dedicated to flexible staffing solutions, is currently recruiting for a Regulatory Coordinator for one of the most innovative pharmaceutical company in the world based in the Brussels area.

For our client facing positions, you must be confident, be able to drive the role and to work autonomously. You will have a close relationship with our Line Managers, who will provide you with mentoring and guidance. Most of our roles are permanent positions with CROMSOURCE and you will be working on projects for just one client. We are open, friendly and approachable and aim to support you through the recruitment process every step of the way.

Scope of the role:

This position assists and supports the CSS Regulatory Affairs, Global Strategic Implementation Department in the execution of regulatory activities.

Based in the European HQ in Belgium, the Regulatory Affairs Coordinator reports to the Regulatory Affairs Manager, Strategic Programs.

Position Duties & Responsibilities:
  • Assists and supports the team members in the execution of regulatory strategies impacting all CSS for MDR Implementation and Execution
  • Gathers and assembles data necessary for the development of the regulatory aspects of project plans including tracking, planning and communication
  • Assists in the execution of regulatory strategies for non-EU countries, including coordinating and tracking document requests
  • Creates and approves ECO's pertaining to the Coordinator's projects and duties (including but not limited to SOPs, EU labeling approval)
  • Responsible for administrative tasks to support the CSS MDR activities including preparation of meetings and general administrative activities
  • Responsible for compiling reports, presentations and creating flowcharts
  • Researches, collects, cross-check data from different sources, and responds to requests from internal colleagues
  • Responsible for communicating business related issues or opportunities to next management level For those who supervise or manage a staff,
  • Responsible for ensuring that subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition, if applicable
  • Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures
  • Performs other duties assigned as needed


Education & Experience:
  • A university, bachelor's degree or equivalent,
  • 0-2 years of work experience, preferably but not limited to regulatory affairs


Skills:
  • Good command of database and spreadsheet software
  • Excellent written and verbal communication skills in English
  • Creative and good computer skills: Excel, Power Point, One Note, Microsoft Team
  • Attention to details
  • Capacity to work independently and remotely
  • Ability to take on diverse tasks, good organizational skills


The Benefits of Working for TalentSource in Belgium
  • Competitive Salary
  • Group and hospitalisation insurance
  • Electronic meal vouchers
  • Internet reimbursement
  • Company Car with fuel card depending on the function
  • Dedicated Line Manager
  • Regular facetoface or phone meetings with line manager
  • Full annual performance review process
  • Adhoc team events and end of year party
  • Career opportunities within both our CRO departments and our TalentSource Life Sciences Unit, locally and internationally
  • Employee satisfaction survey your feedback is important for continuous improvement


Who will you be working for?

About CROMSOURCE

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=HQ00002311

or please contact Rocio.EgeaMota@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 Coordinator
Skills: Regulatory Location: Belgium Share:

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CROMSOURCE is an ISO-certified international provider of fully outsourced services to the pharmaceutical, biotechnology and medical device industries, specialised in clinical development and flexible resourcing solutions. CROMSOURCE was founded in 1997 and its successful growth has been built on stability, integrity, and high levels of customer satisfaction. We have grown steadily through offices across all regions of Europe and North America and delivering a comprehensive breadth of services.

Acting through PharmaceuticalMedical Device and Flexible Resourcing Solutions teams, and with a comprehensive portfolio of services, we offer a flexible approach to ensure CROMSOURCE optimally supports the unique needs of each client. This could mean providing regulatory consultancy to a small company at the early stages of a medical device development programme, through to provision of full services to a pharmaceutical company performing an international mega-trial to support registration of their product. Whatever the size and scope of the project, each receives the same level of attention to detail and commitment to delivery of a high quality service within budget and to timelines agreed.

We are experts providing experts and we live by our motto – Advise Agree Deliver. This means we leverage our experience and expertise at the early stages of discussions with our clients to freely advise them on the optimal project plan. We then reach agreement with each client on the scope of service, timelines and budget. CROMSOURCE then commit to deliver those services on time and within budget – according to our End-to-End Guarantee and this commitment to guaranteed delivery is unique in the clinical research environment.

Contact Us
  • 6-9 The Square
  • Stockley Park
  • Hayes
  • UB11 1FW
  • United Kingdom
  • +44 (0) 1786 468990
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