Senior Regulatory Affairs Specialist

il y a 4 jours

belgium be Aspen Pharma Group Temps plein

The Senior Regulatory Affairs Specialist is responsible for managing regulatory activities for assigned countries, ensuring compliance with local regulations and timely product registration. This includes handling submissions, maintaining marketing authorizations, addressing health authority queries, and ensuring registration dossiers meet standards. The role involves strategic regulatory input, liaising with internal and external stakeholders, and monitoring the impact of regulatory changes on submissions and product lifecycle. Key Responsibilities: Regulatory Submissions & Compliance: Prepare and manage registration dossiers, maintain marketing authorizations, and respond to health authority queries. Stakeholder Communication: Provide updates to internal teams and liaise with health authorities and service providers. Strategic Support: Contribute to regulatory strategy and assess the impact of changing regulations. Lifecycle Management: Manage variations, renewals, and regulatory changes for assigned products. Promotions and Marketing: Ensure compliance of promotional material with national regulations. Quality & Documentation: Oversee labelling, maintain accurate records, and support audits and inspections The role requires a high level of integrity, adaptability, and a solutions-driven mindset, with the ability to work autonomously and within a matrix team environment.

  • Arts-specialist Gynaecologie

    il y a 4 jours

    be UZ Gent Temps plein

    FunctieomschrijvingBenigne gynaecologie – Vulvakliniek - Menopauzekliniek Samen met een senior staflid  zelfstandig consultaties verrichten binnen de benigne gynaecologie, de menopauzekliniek en de vulvakliniek actief en structureel de samenwerking met aanverwante en betrokken disciplines bevorderen en de multidisciplinaire zorg optimaliseren. zich verder...

  • Specialists in CSOs and Social Partners

    il y a 1 semaine

    Belgium NTU International AS Temps plein

    Specialists in Civil Society Organisations (CSOs) and Social PartnersLocation: EuropeContract Type: Project-Based/ConsultancyApplication Deadline: Rolling ApplicationsAbout the Opportunity:We are creating a pool of Civil Society Organisations (CSOs) and Social Partners experts for European Training Foundation (ETF) projects in Europe. Experts in this pool...

  • Head of CMC

    il y a 2 semaines

    Belgium Planet Pharma Temps plein

    About the RoleWe are seeking an experienced and visionary Head of CMC Development to lead and manage our Chemistry, Manufacturing, and Controls (CMC) team. This is a senior leadership role with responsibility for shaping CMC strategy, driving process development, and ensuring seamless scale-up and supply of clinical materials. The position covers small...

  • Site Activation Manager Open to Several Emea Countries

    il y a 1 semaine

    Belgium Syneos Health, Inc. Temps plein

    **Site Activation Manager ** open to several EMEA countries**: **Updated**: April 23, 2025 **Location**: Belgium-Europe - BEL-Home-Based **Job ID**:25002852 **Site Activation Manager ** open to several EMEA countries** Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate...

  • SAP Controlling

    il y a 4 jours

    belgium Delaware Temps plein

    Careers divider Jobs divider SAP Controlling (CO) Senior Consultant divider SAP Controlling (CO) Senior Consultant SAP, finance, lot of experience, consultant Belgium The delaware SAP Finance & Business Controlling team has an exciting challenge waiting for our new SAP Controlling (CO) Senior Consultant. The ideal candidate is a highly skilled and motivated...

  • Senior .NET Developer @ Seafar

    il y a 2 semaines

    Belgium Amon Temps plein

    Seafar, established in 2018, has emerged as a trailblazer in the field of remote and autonomous maritime operations. Seafar is an independent ship management company (founded by Louis-Robert Cool), offering services to operate unmanned and crew-reduced vessels for ship owners and shipping companies. Via their Remote Operating Center (ROC), they manage and...

  • Regional Sales Manager

    il y a 2 semaines

    Belgium Guided Solutions Temps plein

    An international medical device organisation is seeking a Regional Sales Manager to lead commercial strategy and drive market growth across the region. This is a pivotal leadership role responsible for building, coaching, and motivating high-performing sales professionals and distributors while achieving and exceeding national revenue targets.Reporting into...

  • Senior consultant Financial Advisory

    il y a 1 semaine

    vlaams gewest, be Moore Global Temps plein

    Wat je moet weten over ons Moore is een grote werkgever met het karakter van een kleine organisatie: korte lijnen, snelle beslissingen, no-nonsense cultuur en veel ondernemerszin. Wij bieden medewerkers boeiende uitdagingen in een bedrijf dat dicht bij de klant staat en een brede dienstverlening biedt in Accountancy, Audit, Corporate Finance, Tax & Legal,...

  • Biopharma Business Development Manager

    il y a 4 semaines

    Belgium Hologic Temps plein

    Hologic Diagenode and its international Life Sciences business franchise is recognized as a leader in Epigenomics, providing innovative instruments, reagents, systems, and services for life science research. With a full suite of products (e.g., Bioruptor®, Megaruptor® DNA shearing instruments, ChIP kits, DNA methylation and RNA analysis kits, and premium...

  • Solution Architect

    il y a 1 semaine

    belgium Euroclear Temps plein

    Division: Group Business Solutions (GBS)Within GBS, you will join the Solutions Architecture team in the Software Engineering Tribe. Here, you will play a crucial role in defining the target architecture and designing end-to-end solutions for initiatives across various GBS domains with a focus on our EB Settlement domain and actively participate in the...