Regulatory Coordinator CMC

You have more than 3 years experience as a Regulatory Writer in pharma? Don't hesitate to apply.
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What we offer

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 an experienced Regulatory Coordinator in CMC to join our consulting team for a client project based in Wavre

Your challenges will be : 

  • Definition of the strategy for the submission of technical (quality) change
  • Preparation, authoring and coordination of CMC submissions related the life-cycle maintenance of Vaccines (CMC variations, commitments, market expansions, answers to questions from world-wide regulatory authorities).
  • Maintenance of regulatory dossiers.
  • Interactions with regulatory and technical contributing disciplines Teams (QC, QA, Production, Supply) to ensure File content definition,
  • Use of regulatory information management systems such as Documentum, Liquent, and Veeva Vault
  • Under supervision of a CMC manager, liaise with contributing disciplines to define technical file content
  • Ensure planning and proper organisation of activities (for technical/CMC and procedural aspects) in line with the overall project plan and RA milestones
  • Compile/write high quality project/product specific regulatory documents to be submitted to Authorities (for technical/CMC and procedural sections) and ensure that those documents meet regulatory requirements.
  • Ensure coordination of activities related to CMC submission file preparation, including change control assessment, source documents collection from key contributing discipline, initiation and management of CMC submission kick-off meeting, file authoring, review and approval
  • Provide support to the supervisor via critical review of the technical section of regulatory documents
  • Ensure liaison with and coordination between RA teams, RA management, Regulatory operations and any other stakeholders involved in the program
  • Report significant issues to the management

Profile

  • Experience in CMC regulatory affairs /Technical Life Cycle Management, preferably with biologicals/vaccines, proven ability to manage typical regulatory activities, resolve problems and deliver results.
    • Experience in CMC authoring of CMC technical variations and Module 3 components, preferably with biologicals/vaccines,
    • Experience in Project Management
    • Experience in change control process
    • Experience working with Biologics/vaccines preferred
    • Experience with managing submissions in EU, US and major regulatory markets preferred

Skills

  • Fluent in English (will be required to interact daily with teams based around the world)
    • Quality mindset - Ensure rigorous scientific content/quality/compliance of documents intended for regulatory submissions.
    • Manages own time to meet agreed short-term targets. Ability to clearly identify priorities and manage multiple tasks
    • Good communication skills
    Analytical skills, creative and critical mind
    • Team player

      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 skilfully, 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

        Hybrid remote

      We usually respond within a week

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

      Waterloo, Belgium

      Drève Richelle 161
      1410 Waterloo 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! 

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