Impactful CMC Regulatory Writer

ppstrongWhat we will accomplish together: /strong /ppAlsinova is looking on stronga regular basis for Technical Regulatory CMC Writers /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 /pulliThe 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…. /liliWrite CMC, “facility and equipment” parts and new files for WW regulatory File. /liliManage and schedule with SMEs and Site conformance (and Production, Validation and Quality Assurance) thewriting/review process to ensure timely completion. /liliEnsure the coordination with the departments involved in the writing/review process. /liliWrite and support regulatory affairs Responses to Questions raised by Regulatory Authorities. /liliMonitor that supportive data provided by other departments are compliant. /liliReport significant issues. /liliManage the projects within all company/GRA tracking tools. /liliAssess the change controls that relate to pure facilities and equipment matters or work with GRL teams for changecontrols impacting both CMC and facilities. /li /ulpstrongYou: /strong /pulliUniversity level (Life Sciences background is preferred) or equivalent by experience. /li /ululliAt least 3 years of experience in writing CMC (technical) parts of regulatory documents (registration files or variations). /liliExperience working in validation/QA/production in Biologics/Pharmaceuticals industry. /liliKnowledge of regulatory procedures / systems / guidance. /liliKnowledge of biologic process and process equipment. /liliKnowledge of Qualification / Validation principles. /liliManages own time to meet agreed short-term targets. /liliMicrosoft. /liliPowerPoint Excel. /li /ululliGood communication skills. /liliWriting skills. /liliAnalytical skills, creative and critical mind. /liliEnsures the coherence between contributions / quality of final results. /liliTeam player. /li /ululliFrench. /liliGood level of spoken and written English. /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