Regulatory Affairs CMC Officer – Paris, France

OverviewRegulatory Affairs CMC Officer – Paris, France (F/M) role at Alsinova, the CRO subsidiary of the Astek Group. Alsinova is currently recruiting a Regulatory Affairs CMC Officer to strengthen its regulatory affairs team and support strategic projects in the pharmaceutical industry.Your MissionWorking closely with our clients in the Life Sciences sector and reporting to the Regulatory Affairs Manager, you will be responsible for CMC-related regulatory activities across the lifecycle of pharmaceutical products. You will play a key role in ensuring the regulatory compliance of technical documentation (CTD Module 2 and 3), defining submission strategies, and coordinating with both internal teams and health authorities.Your Daily Activities Will BeAnalyze CMC regulatory requirements for each product or submissionContribute to the development and execution of CMC regulatory strategiesMonitor and implement CMC regulatory intelligence and guidance updatesPrepare and write renewal dossiers (MAA – Marketing Authorization Applications)Draft the CMC sections of Module 2 and 3 in CTD formatEnsure consistency and compliance of the full submission packagePrepare and submit marketing authorization applications (new, variations, renewals)Interact with Health Authorities and stakeholders throughout submission processesGather necessary data and documents from technical departmentsSupport internal teams with CMC regulatory guidanceYour Future TeamYou\'ll join a committed, collaborative and agile regulatory team that values mutual support, scientific rigor, and ownership. Our consultants work in an environment that promotes expertise sharing, autonomy, and real career development. You will benefit from continuous support by your manager and a solid onboarding process to ensure a smooth integration.Organized, autonomous, with strong communication skills and attention to detail.YouMaster\'s degree, PharmD or equivalent with specialization in Regulatory AffairsMinimum 3 years of experience in CMC Regulatory AffairsProven experience in drafting CTD Module 2 and 3Strong background in CMC documentation and writingIdeally familiar with Veeva Vault RIM or similar regulatory toolsFluent English and French, both spoken and writtenWe Base Our Relationships OnRespect for employees and clients, and their aspirationsPersonalized support for employees and clientsRegular career managementTransparent communicationConstant responsiveness, availability, and attentivenessOrganized, autonomous, with strong communication skills and attention to detailAlsinova is setting new standards for CROs by integrating multidisciplinary expertise with advanced technology. 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. 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 10 000 employees who are committed every day to promoting combination of digital technologies and complex systems engineering.Join a Group rapidly developing in France and around the world, with a turnover of 705 M€ in 2024. More on the Group on our websites alsinova.com and astek.net.Astek is committed to the employment of people with disabilities.Our BenefitsJoining Astek means choosing:an experience accelerator, where every assignment is an opportunity to progressaccess to a multitude of technically exciting projects for our clients as well as internallyindividualized, local support for a tailored career pathcontinuous learning, thanks to our internal training academya friendly and inclusive work environment, supported by #TopEmployer2025 certified HR practicesLet\'s move forward.Seniority levelMid-Senior levelEmployment typeFull-timeJob functionLegalReferrals increase your chances of interviewing at Astek Middle East by 2xGet notified about new Regulatory Affairs Officer jobs in Paris, Île-de-France, France.Regulatory Affairs CMC Officer - Paris, France (F/M)Neuilly-sur-Seine, Île-de-France, France 3 days agoNeuilly-sur-Seine, Île-de-France, France 3 weeks agoRegulatory Affairs Officer (Medical Device)Boulogne-Billancourt, Île-de-France, France 3 months agoRegulatory Affairs Senior Specialist – Scent EAMESuresnes, Île-de-France, France 2 weeks agoSenior Manager, Global Regulatory AffairsBoulogne-Billancourt, Île-de-France, France 3 months agoWe’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI. #J-18808-Ljbffr