Clinical Regulatory Coordinator

You are a true warrior with your trilingual skills and knowledge in regulations? Ready to become a Keyrus Life Sciences Ninja? We are...
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What we offer

Looking for your next challenge as Clinical Regulations Coordinator? 

Joining our consulting team in Belgium means giving your career a step forward. Thanks to the privileged partnership we have with our well-established clients, leaders in their domain, we offer our consultants unique projects to develop their skills, and put their professional experience in the pharma industry on the fast track.

As an expert on the client side, you can count on us to support you at each step of your project thanks to regular touch points with our Key Account Manager. We then also carefully choose with you what would be your next assignment that is matching your career goal whether it is in Consulting or in one of our Functional Services Platforms.

We invest considerable time and resources in training our staff (technical and non-technical courses) to continuously support you in your personal and professional growth. On top of this, you will receive a complete salary package including attractive extra-legal benefits (company car, petrol card, meal vouchers, group insurance, hospitalization…) based on your background and experience.

 

Job Description

Keyrus Life Science is looking for a Regulatory Coordinator to join our consulting team for a client project based in Anderlecht, Belgium

Your challenges will be : 

  • Ethics Committee Activities
  • Solicit input from clinical teams on assigned synopses, protocols and Informed Consent Documents (ICDs) where appropriate;

    Ensure the accuracy of managed ICDs and their translations, as well as related regulatory documents for assigned protocols

    Responsible for preparing CTA submissions to Ethics Committee(s);

    Responsible within the Regulatory Team to ensure that studies are conducted scientifically and ethically and in compliance with EMA/FDA/ICH/GCP guidances and regulations/laws.

    Coordinates with PCRU Pharmacists, RegCMC and Dev Ops colleagues to ensure timely and accurate submission of studies to the Ethics Committee(s)

    Lead the administrative work related to completion of trials (CSR, ASR, SUSAR, AE, etc.), and ensure communications to EC.

    Ensure end of study reports and annual reports are provided in time to Ethics Committees.

  •  Regulatory Authorities Activities
    Responsible for preparing CTA submissions to Competent Authorities;

    Responsible within the Regulatory Team to ensure that studies are conducted scientifically and ethically and in compliance with EMA/FDA/ICH/GCP guidances and regulations/laws.

    Coordinates with PCRU Pharmacists, RegCMC and Dev Ops colleagues to ensure timely and accurate submission of studies to the Competent Authorities;

    Lead the administrative work related to completion of trials (CSR, ASR, SUSAR, AE, etc.), and ensure communications to CA;

    Ensure end of study reports are provided in time to Regulatory Authorities.

  • Other Activities
    Responsible for study-specific tasks such as site registration in CTMS/Oracle Siebel and Shared Investigator Platform (SIP), QC and filling of study documents in PTMF as well as maintenance and archiving of study files (ISF)

    Act as an SME for SOP updates and review within the functional line

    Responsible for providing oversight on specialized regulatory related PCRU projects

    Liaison to the project teams for studies scheduled in the PCRU to provide inputs on regulatory aspects;

    Responsible for the implementation of new processes and work to proactively resolve issues where appropriate;

    Develop knowledge of the GDPR and optimize its implementation at the PCRU.

    Lead PCRU teams in accomplishing business needs and resolving issues;

    Represent the PCRU on local or global initiatives as a subject matter expert where appropriate

    Develop and maintain relationships with schools and universities for training site registration

    Give input in PCRU documentation to facilitate positive attitude and trust of participants toward clinical research

    Participate in training courses as appropriate, and train Regulatory team members with less experience and expertise.

Profile
  • Bachelor’s degree in management, Life Sciences or equivalent, with relevant experience in Regulatory Affairs.
    A Master in the above-mentioned domains is preferred.
  • Autonomous but with a strong team spirit, 
  • Accountable, with very keen sense of initiative and leadership skills
  • Strong organizational skills, multiple projects flexibility and very good resistance to stress or a high workload.
  • Detail oriented, precise in oral and written communication
  • Strong IT skills: advanced use of MS Office tools such as Outlook, Word, Excel, PowerPoint, Teams, OneNote.
  • Min. 5 years of experience in pharma, of which at least some years in a regulatory environment 
  • Working knowledge of ICH and GCP guidelines required
  • Strong understanding and knowledge of regulatory aspects of drug development
  • Languages : Fluent in French, Dutch and English (written and spoken)
    Scientific / Medical Knowledge
  • Understanding of basic clinical pharmacology principles, with ability to review emerging safety and efficacy profile of a drug candidate and recognize potential serious adverse effects.
  •  Demonstrated understanding of the complexities and recent developments in exploratory research.
  • Participates to the successful study conduct of PCRU studies in accordance with ethical, legal, and moral standards, Good Clinical Practices, Good Laboratory Practices, PCRU management requests, Clinical Development and operations (CD&O) and Global product Development (GPD) goals.

 

Who we are

Keyrus Life Science is an international Consulting, Contract Research Organisation and Functional Services provider with a reputation for transparency and integrity, highly focused on being able to deliver with excellence. Our ‘human’ approach to service provision is what differentiates us from our competitors. Combined with our high caliber staff, this approach has allowed us to become a key player in clinical research.

At Keyrus Life Science we’re proud of our commitment to delivering services of the highest quality, not only skillfully, efficiently and reliably, but also with sincerity and genuine care for our clients’ projects, priorities and reputation. Thus we maintain and advance our vision and our standards, all the while ensuring that we serve your interests better

From early- to late-stage drug development, our range of services includes: Project Management, Clinical Operations, Pharmacovigilance, Quality Assurance (GxP), Regulatory Affairs Strategy & Support, Data Management, Medical Review & Coding, Biostatistics, Medical Writing & Medical Information, Real World evidence services.

 

Additional information

  • Remote status

    Flexible remote

We usually respond within a week

Or, know someone who would be a perfect fit? Let them know!

Brussels

1000 Brussels Directions

Our offices are the place where you are always welcome when you are not working on client's site or from home. Every single person that joins us is met in a personal and unique way.

What is really common to all of us, is the envy to contribute to the improvement of people’s health. Every employee being part of Keyrus Life Science is therefore fully committed to making the world a better place to live.   

With us, you will be part of our family and feel our human approach culture as of Day 1! 

Already working at Keyrus Life Science Belgium?

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