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Regulatory Affairs Consultant (candidate pool), Belgium
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Client:
Keyrus Life Science
Location:
Job Category:
Other
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EU work permit required:
Yes
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Job Reference:
2d6099885896
Job Views:
8
Posted:
20.08.2025
Expiry Date:
04.10.2025
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Job Description:
Job Description
Keyrus Life Science is looking on a regular basis for Regulatory Affairs Consultants to join our consulting team for clients (from big pharma to small biotech) projects based in Belgium.
This job description is an example of how your job could look like. Once we have a specific project and client, you will be informed, and you will have the choice to be presented to our client.
Your potential challenges could be:
* Guide our client by interpreting federal, state, and international regulations as they apply to products, processes, practices, and procedures.
* Be responsible for product registration activities of the assigned products and report to the Regulatory Strategy Senior Manager.
* Work in cross-functional teams with different departments (manufacturing, labs, QA, supply, etc.) and collaborate with R&D, global regulatory colleagues (Global Chemistry, Manufacturing & Controls (GCMC)) to support the introduction of new products at our client's site.
* Your hard work and dedication will help our client achieve new milestones and help patients across the globe.
Scope of work:
* Support regulatory submissions (CTD, BLA, NDA, etc.) of the products by informing site colleagues of regulatory requirements and authoring the dossier.
* Liaise with regulatory colleagues to communicate and resolve potential issues.
* Collaborate with other stakeholders to deliver high-quality CMC submissions and ensure compliance of our client's portfolio.
* Manage timely responses to Board of Health requests resulting from lifecycle submissions.
* Assess post-approval changes at the manufacturing site and the associated regulatory variations, authoring impacted sections of the dossier.
* Contribute to project completion, manage own time to meet targets, and develop work plans within a team to support operational goals.
Profile
* Master's degree in Life sciences (e.g., industrial pharmacist, biomedical sciences, bio-engineer, etc.).
* Experience in the pharmaceutical sector (or equivalent by acquiring a PhD), with experience in regulatory (authoring CTD, BLA) and quality.
* CMC experience is a real asset.
* Scientific knowledge, analytical skills, and technical writing skills for regulatory documentation.
* Knowledge of drug regulations and guidance from agencies like EMA and FDA.
* Effective communication, negotiation, and influencing skills.
* Dynamic, flexible, enthusiastic, eager to learn.
* Ability to work independently and in a team.
* Fluent in written and spoken English and French or Dutch.
What we offer
Joining our team offers career advancement opportunities through unique projects, continuous training, and a comprehensive salary package with attractive benefits (company car, petrol card, meal vouchers, insurance, etc.) based on experience.
Who we are
Keyrus Life Science is an international provider of consulting, contract research, and services in clinical research, committed to quality, transparency, and integrity. Our human approach and high-caliber staff differentiate us, enabling us to deliver excellence across early- to late-stage drug development services.
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