Senior Regulatory Affairs | Remote

Regulatory CMC ExpertCMC Strategy & MAA Submission 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 remote-friendly engagement package tailored to your location within Europe, based on your background and experience. About the RoleWe are looking for an experienced Global Regulatory CMC Expert to lead the regulatory CMC strategy for a small molecule in advanced clinical development, with a Marketing Authorisation Application (MAA) currently in preparation. You will act as the key liaison between technical, medical writing, quality, supply chain and Global Regulatory Affairs teams, ensuring the CMC dossier is built to the highest standard and aligned with the requirements of health authorities across multiple regions. This is a fully remote assignment open to candidates based anywhere in a European time zone, available to start as soon as possible. Key ResponsibilitiesDefine and lead the global regulatory CMC strategy for a small molecule in late-stage developmentCoordinate preparation and submission of the CMC Dossier (Module 3) with technical and medical writing teamsAct as the primary interface between Development, Quality, Supply Chain and Global Regulatory AffairsManage interactions with regulatory agencies (EMA, FDA, ICH) and prepare briefing books Main ActivitiesDrive the global CMC regulatory strategy in support of the upcoming MAA submissionOversee compilation and quality of Module 3 content in partnership with technical and medical writing teamsLead cross-functional coordination with Development, Quality, Supply Chain and Global Regulatory AffairsManage regulatory agency interactions (EMA, FDA, ICH) and prepare associated briefing booksConduct gap analyses, manage regulatory risk, and adapt submissions to country-specific requirementsProvide transverse leadership and project management across all CMC regulatory workstreams Required Qualifications10+ years of experience in Regulatory CMC, ideally including global MAA/NDA submissionsProven experience leading regulatory CMC strategy for small molecules in late-stage developmentHands-on experience preparing and submitting CMC dossiers (Module 3)Working knowledge of international regulatory requirements: Europe, US, China, Japan, Brazil, CanadaExperience managing agency interactions (EMA, FDA, ICH) and briefing book preparationStrong strategic mindset, transverse leadership and project management skillsScientific background: PharmD, MSc or PhDFluent English required, French is an asset Our BenefitsJoining Astek means choosing an experience accelerator, where every assignment is an opportunity to progress; access to a multitude of technically exciting projects for our clients as well as internally; individualized, local support for a tailored career path; continuous learning, thanks to our internal training academy; and a friendly and inclusive work environment, supported by #TopEmployer2026 certified HR practices. Let's move forward.Alsinova - An Astek Company