Technical Regulatory CMC Writer – Waterloo, Belgium

ph3What we will accomplish together: /h3 /brpAlsinova is looking on ba regular basis for Technical Regulatory CMC Writers /b to join our consulting team for clients’ projects (from big pharma to small biotech) based in bBelgium. /b /p /brh3Your mission (should you decide to accept it): /h3 /brpYour potential challenges will be various, depending on the clients’ priorities. The list below gives you examples of our classic activities. /p /brh3Your daily activities will be: /h3 /brul /brliThe Technical Regulatory Writer is involved in the company’s regulatory activities related to new existing products, on a domestic or international basis. Activities focus on technical writing for Facilities, major and minor submissions…. /li /brliWrite CMC, “facility and equipment” parts and new files for WW regulatory File. /li /brliManage and schedule with SMEs and Site conformance (and Production, Validation and Quality Assurance) thewriting/review process to ensure timely completion. /li /brliEnsure the coordination with the departments involved in the writing/review process. /li /brliWrite and support regulatory affairs Responses to Questions raised by Regulatory Authorities. /li /brliMonitor that supportive data provided by other departments are compliant. /li /brliReport significant issues. /li /brliManage the projects within all company/GRA tracking tools. /li /brliAssess the change controls that relate to pure facilities and equipment matters or work with GRL teams for changecontrols impacting both CMC and facilities. /li /br /ul /brh3You: /h3 /brul /brliUniversity level (Life Sciences background is preferred) or equivalent by experience. /li /br /ul /brul /brliAt least 3 years of experience in writing CMC (technical) parts of regulatory documents (registration files or variations). /li /brliExperience working in validation/QA/production in Biologics/Pharmaceuticals industry. /li /brliKnowledge of regulatory procedures / systems / guidance. /li /brliKnowledge of biologic process and process equipment. /li /brliKnowledge of Qualification / Validation principles. /li /brliManages own time to meet agreed short-term targets. /li /brliMicrosoft. /li /brliPowerPoint Excel. /li /br /ul /brul /brliGood communication skills. /li /brliWriting skills. /li /brliAnalytical skills, creative and critical mind. /li /brliEnsures the coherence between contributions / quality of final results. /li /brliTeam player. /li /br /ul /brul /brliFrench. /li /brliGood level of spoken and written English. /li /br /ul /brpAlsinova – An Astek Company /p /brpbAlsinova is setting new standards for CROs by integrating multidisciplinary expertise with advanced technology. /b 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 /brpAlsinova is the subsidiary of the Astek Group,b a global player in engineering and technology consulting. /b 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 /brh3Join a Group rapidly developing in France and around the world, with a turnover of 730 M€ in 2025. /h3 /brpMore on the Group on our websites and /p /brh3Astek is committed to the employment of people with disabilities. /h3 /brh3Our benefits /h3 /brpJoining Astek means choosing: /p /brul /brlian experience accelerator, where every assignment is an opportunity to progress /li /brliaccess to a multitude of technically exciting projects for our clients as well as internally /li /brliindividualized, local support for a tailored career path /li /brlicontinuous learning, thanks to our internal training academy /li /brlia friendly and inclusive work environment, supported by #TopEmployer2026 certified HR practices /li /br /ul /brh3Let’s move forward. /h3 /p