Regulatory Affairs – Waterloo, Belgium (F/M)

<p><h3>What we will accomplish together: </h3> <p>Alsinova is looking on <b>regular basis for Regulatory Affairs Consultants </b> to join our consulting team for clients’ projects (from big pharma to small biotech) based in <b>Belgium. </b> </p> <h3>Your mission (should you decide to accept it): </h3> <p>Your potential challenges will be various, depending on the clients’ priorities. The list below gives you examples of our classic activities. </p> <h3>Your daily activities will be: </h3> <ul> <li>Guide our clientby interpreting federal, state and international regulations as they apply to products, processes, practices and procedures. </li> <li>Be responsible for product registration activities of the assigned products and will report to the Regulatory Strategy Senior Manager. </li> <li>Work in cross-functional teams with different departments (manufacturing, labs, QA, supply,…) and collaborate with R&D, global regulatory colleagues (Global Chemistry, Manufacturing & Controls (GCMC)) in order to support the introduction of new products at our client’s site. </li> <li>It is your hard work and dedication that will make our clientready to achieve new milestones and help patients across the globe. </li> </ul> <h3>Scope of work: </h3> <ul> <li>Support regulatory submissions (CTD, BLA, NDA,…) of the products by informing site colleagues of regulatory requirements and by authoring the dossier. </li> <li>Liaise with regulatory colleagues to communicate and resolve potential issues. </li> <li>Collaborate across the network of other stakeholders to deliver high quality CMC submission and ensuring compliance of our client’s portfolio. </li> <li>Manage timely responses to Board of Health requests resulting from lifecycle submissions in markets or products under responsibility. </li> <li>Assess post approval changes at the manufacturing site and the associated regulatory variations. You are responsible for authoring the impacted sections of the dossier. </li> <li>Contribute to the completion of projects, manage own time to meet agreed targets and develop plans for work activities within a team to support operational goals. </li> </ul> <ul> <li>Ability to communicate effectively verbally and in writing, good negotiation and influencing skills. </li> <li>Dynamic, flexible, enthusiastic and eager to learn. </li> <li>Ability to work under minimal supervision and in a team. </li> </ul> <h3>You: </h3> <ul> <li>Master degree in Life sciences (e.g. industrial pharmacist, biomedical sciences, bio-engineer,..). </li> </ul> <ul> <li>Experience in the pharmaceutical sector (or equivalent by acquiring a PhD), with experience in regulatory (authoring CTD, BLA) and quality. </li> <li><b>CMC experience is a real asset. </b> </li> <li>Scientific knowledge, analytical skills associated with technical writing skills to issue RFT regulatory documentation. </li> <li>Knowledge of drug regulations and regulatory guidance of leading agencies (EMA, FDA). </li> </ul> <ul> <li><b>Fluent in written and spoken English and French or Dutch </b>. </li> </ul> <ul> <li>Ability to communicate effectively verbally and in writing, good negotiation and influencing skills. </li> <li>Dynamic, flexible, enthusiastic and eager to learn. </li> <li>Ability to work under minimal supervision and in a team. </li> </ul> <p>Alsinova – An Astek Company </p> <h3>Alsinova is setting new standards for CROs by integrating multidisciplinary expertise with advanced technology. </h3> <p>Alsinova offers a complete CRO solution, providing innovative, customised solutions in various life science segments: pharmaceuticals, biotechnology, medical devices, cosmetics, agri-food, veterinary and healthcare institutions. </p> <p>Alsinova is the subsidiary of the Astek Group, a global player in engineering and technology consulting. Since its creation, the Group has based its development on a strong culture of entrepreneurship and innovation, and on the support and skills development of its <b>10 000 employees </b> who are committed every day to promoting combination of digital technologies and complex systems engineering. </p> <p><b>Join a Group rapidly developing in France and around the world, with a turnover of 730 M€ in 2025. </b> </p> <p>More on the Group on our websites and </p> <p><b>Astek is committed to the employment of people with disabilities. </b> </p> <h3>Our benefits </h3> <p>Joining Astek means choosing: </p> <ul> <li>an experience accelerator, where every assignment is an opportunity to progress </li> <li>access to a multitude of technically exciting projects for our clients as well as internally </li> <li>individualized, local support for a tailored career path </li> <li>continuous learning, thanks to our internal training academy </li> <li>a friendly and inclusive work environment, supported by #TopEmployer2026 certified HR practices </li> </ul> <p><b>Let’s move forward. </b> </p> </p> #J-18808-Ljbffr