Senior Regulatory Affairs | Remote

Senior Regulatory Affairs CMCDrug Substance (Small Molecules) – ADC Linker-Payload | Remote, Flexible What We OfferJoining our consulting team in Belgium means giving your career a step forward. Thanks to the privileged partnership we have with our well-established clients, leaders in their domain, we offer our consultants unique projects to develop their skills, and put their professional experience in the pharma industry on the fast track. As an expert on the client side, you can count on us to support you at each step of your project thanks to regular touch points with our Key Account Manager. We then also carefully choose with you what would be your next assignment that is matching your career goal, whether it is in Consulting or in one of our Functional Services Platforms. We invest considerable time and resources in training our staff (technical and non-technical courses) to continuously support you in your personal and professional growth. On top of this, you will receive a complete salary package including attractive extra-legal benefits (company car, petrol card, meal vouchers, group insurance, hospitalization…) based on your background and experience. About the RoleWe are looking for a Senior Regulatory CMC Consultant with strong Drug Substance development experience (small molecules) to join our Regulatory CMC team. The successful candidate will lead the regulatory strategy for the linker-payload component of an Antibody-Drug Conjugate (ADC) currently in late-phase development, in preparation for the upcoming Marketing Authorisation Application. Key ResponsibilitiesLead the CMC Drug Substance (small molecules) aspects of global Marketing Authorisation submissions (EU & FDA)Define and drive the regulatory strategy for the linker-payload component of the ADCEnsure alignment with ICH, FDA and EMA guidelines and requirements for the Drug Substance section of Module 3Collaborate within multi-functional teams, building networks and alliances across the organisationApply strong analytical and critical thinking skills to Drug Substance (small molecules) topicsPrioritise and manage multiple tasks, projects and objectives simultaneously Required QualificationsApproximately 10 years of experience in Regulatory CMC, including Drug Substance development (small molecules)Strong experience leading CMC Drug Substance aspects of global Marketing Authorisation submissions (EU & FDA)Sound knowledge of ICH, FDA and EMA guidelines for the Drug Substance section of Module 3Strong regulatory strategic skills, well organised, pragmatic and open-mindedExcellent critical thinking and problem-solving skillsFluent in English (written, spoken and read) LocationFlexible, provided the time zone allows regular collaboration with both US- and EU-based teams. 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 internallyIndividualised, local support for a tailored career pathContinuous learning, thanks to our internal training academyA friendly and inclusive work environment, supported by #TopEmployer2026 certified HR practices Let's move forward.Alsinova — An Astek Company