Regulatory Affairs – Waterloo, Belgium

ph3What we will accomplish together: /h3 pAlsinova is looking on bregular basis for Regulatory Affairs Consultants /b to join our consulting team for clients’ projects (from big pharma to small biotech) based in bBelgium. /b /p h3Your mission (should you decide to accept it): /h3 pYour potential challenges will be various, depending on the clients’ priorities. The list below gives you examples of our classic activities. /p h3Your daily activities will be: /h3 ul liGuide our clientby interpreting federal, state and international regulations as they apply to products, processes, practices and procedures. /li liBe responsible for product registration activities of the assigned products and will report to the Regulatory Strategy Senior Manager. /li liWork in cross-functional teams with different departments (manufacturing, labs, QA, supply,…) and collaborate with RD, global regulatory colleagues (Global Chemistry, Manufacturing Controls (GCMC)) in order to support the introduction of new products at our client’s site. /li liIt is your hard work and dedication that will make our clientready to achieve new milestones and help patients across the globe. /li /ul h3Scope of work: /h3 ul liSupport regulatory submissions (CTD, BLA, NDA,…) of the products by informing site colleagues of regulatory requirements and by authoring the dossier. /li liLiaise with regulatory colleagues to communicate and resolve potential issues. /li liCollaborate across the network of other stakeholders to deliver high quality CMC submission and ensuring compliance of our client’s portfolio. /li liManage timely responses to Board of Health requests resulting from lifecycle submissions in markets or products under responsibility. /li liAssess post approval changes at the manufacturing site and the associated regulatory variations. You are responsible for authoring the impacted sections of the dossier. /li liContribute 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 liAbility to communicate effectively verbally and in writing, good negotiation and influencing skills. /li liDynamic, flexible, enthusiastic and eager to learn. /li liAbility to work under minimal supervision and in a team. /li /ul h3You: /h3 ul liMaster degree in Life sciences (e.g. industrial pharmacist, biomedical sciences, bio-engineer,..). /li /ul ul liExperience in the pharmaceutical sector (or equivalent by acquiring a PhD), with experience in regulatory (authoring CTD, BLA) and quality. /li libCMC experience is a real asset. /b /li liScientific knowledge, analytical skills associated with technical writing skills to issue RFT regulatory documentation. /li liKnowledge of drug regulations and regulatory guidance of leading agencies (EMA, FDA). /li /ul ul libFluent in written and spoken English and French or Dutch /b. /li /ul ul liAbility to communicate effectively verbally and in writing, good negotiation and influencing skills. /li liDynamic, flexible, enthusiastic and eager to learn. /li liAbility to work under minimal supervision and in a team. /li /ul pAlsinova – An Astek Company /p h3Alsinova is setting new standards for CROs by integrating multidisciplinary expertise with advanced technology. /h3 pAlsinova 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 pAlsinova 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 b10 000 employees /b who are committed every day to promoting combination of digital technologies and complex systems engineering. /p pbJoin a Group rapidly developing in France and around the world, with a turnover of 730 M€ in 2025. /b /p pMore on the Group on our websites and /p pbAstek is committed to the employment of people with disabilities. /b /p h3Our benefits /h3 pJoining Astek means choosing: /p ul lian experience accelerator, where every assignment is an opportunity to progress /li liaccess to a multitude of technically exciting projects for our clients as well as internally /li liindividualized, local support for a tailored career path /li licontinuous learning, thanks to our internal training academy /li lia friendly and inclusive work environment, supported by #TopEmployer2026 certified HR practices /li /ul pbLet’s move forward. /b /p /p