Pharma Regulatory Affairs Consultant – CTD/BLA

ppstrongWhat we will accomplish together: /strong /ppAlsinova is looking on stronga regular basis for Regulatory Affairs Consultants /strong to join our consulting team for clients’ projects (from big pharma to small biotech) based in strongBelgium. /strong /ppstrongYour mission (should you decide to accept it): /strong /ppYour potential challenges will be various, depending on the clients’ priorities. The list below gives you examples of our classic activities. /ppstrongYour daily activities will be: /strong /pulliGuide our clientby interpreting federal, state and international regulations as they apply to products, processes, practices and procedures. /liliBe responsible for product registration activities of the assigned products and will report to the Regulatory Strategy Senior Manager. /liliWork 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. /liliIt is your hard work and dedication that will make our clientready to achieve new milestones and help patients across the globe. /li /ulpstrongScope of work: /strong /pulliSupport regulatory submissions (CTD, BLA, NDA,…) of the products by informing site colleagues of regulatory requirements and by authoring the dossier. /liliLiaise with regulatory colleagues to communicate and resolve potential issues. /liliCollaborate across the network of other stakeholders to deliver high quality CMC submission and ensuring compliance of our client’sportfolio. /liliManage timely responses to Board of Health requests resulting from lifecycle submissions in markets or products under responsibility. /liliAssess post approval changes at the manufacturing site and the associated regulatory variations. You are responsible for authoring the impacted sections of the dossier. /liliContribute 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 /ulpstrongYou: /strong /pulliMaster degree in Life sciences (e.g. industrial pharmacist, biomedical sciences, bio-engineer,..). /li /ululliExperience in the pharmaceutical sector (or equivalent by acquiring a PhD), with experience in regulatory (authoring CTD, BLA) and quality. /lilistrongCMC experience is a real asset. /strong /liliScientific knowledge, analytical skills associated with technical writing skills to issue RFT regulatory documentation. /liliKnowledge of drug regulations and regulatory guidance of leading agencies (EMA, FDA). /li /ululliAbility to communicate effectively verbally and in writing, good negotiation and influencing skills. /liliDynamic, flexible, enthusiastic and eager to learn. /liliAbility to work under minimal supervision and in a team. /li /ulullistrongFluent in written and spoken English and French or Dutch /strong. /li /ulpAlsinova – An Astek Company /ppstrongAlsinova is setting new standards for CROs by integrating multidisciplinary expertise with advanced technology. /strongAlsinova 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. /ppAlsinova is the subsidiary of the Astek Group,strong a global player in engineering and technology consulting. /strong 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 strong10 000 employees /strong who are committed every day to promoting combination of digital technologies and complex systems engineering. /ppstrongJoin a Group rapidly developing in France and around the world, with a turnover of 730 M€ in 2025. /strong /ppMore on the Group on our websites and /ppstrongAstek is committed to the employment of people with disabilities. /strong /ppstrongOur benefits /strong /ppJoining Astek means choosing: /pullian experience accelerator, where every assignment is an opportunity to progress /liliaccess to a multitude of technically exciting projects for our clients as well as internally /liliindividualized, local support for a tailored career path /lilicontinuous learning, thanks to our internal training academy /lilia friendly and inclusive work environment, supported by #TopEmployer2026 certified HR practices /li /ulpstrongLet’s move forward. /strong /p /p