Regulatory Affairs Specialist – ATMP

il y a 1 semaine


Antwerpen, Flandre, Belgique Regulatory affairs Temps plein

QbD - Regulatory Affairs Specialist - ATMP in Belgium

Table of Contents

Join our QbD team where Regulatory Affairs services cover regulatory strategy, CTD registration dossier writing, eCTD compilation, and submission to competent authorities, extending to Vigilance. We provide support from concept to commercialization. Are you passionate about ensuring organizational compliance with regulations and laws related to ATMPs? Do you excel in guiding teams through intricate regulatory requirements in an efficient and practical manner? Then consider becoming part of our Regulatory Affairs Division.

What we expect from you as a Regulatory Affairs Specialist - ATMP:

  • You ensure compliance with (inter)national regulations and international standards.
  • You stay updated on evolving regulations in regions relevant to product development, manufacturing, registration, and distribution, advising on business impact.
  • You align departmental operations with approved strategies, objectives, and budgets.
  • You assist clients in obtaining and maintaining marketing authorizations for their products.
  • You provide regulatory guidance to project teams for continuous compliance from early development to post-approval phases.
  • You advise on regulatory and scientific requirements, collecting and evaluating scientific data.
  • You contribute as a CMC writer for IMPD/IND and/or MAA/NDA/BLA submissions.
  • You oversee document exchange and presentation to regulatory authorities.
  • You prepare briefing packages for agency meetings and engage with relevant regulatory agencies.
  • You conduct training on ATMP regulations and submission procedures.

Who are we looking for?

  • You hold a master's degree in a scientific discipline with 2-3 years of experience in regulatory affairs, CMC writing, or non-clinical development in ATMPs.
  • You possess in-depth understanding of ATMP regulations, GMP requirements, and technical standards applicable to ATMPs.
  • You have expertise in preparing regulatory documentation for various stages of ATMP drug development.
  • You are adept at early stage considerations and regulatory plan development.
  • You have strong CMC writing skills to ensure regulatory compliance.

What does QbD Group offer you?

  • An attractive salary package including monthly wage, car, fuel card, insurance, meal vouchers, etc.
  • Opportunities for sustainable careers and meaningful connections.
  • Work for an award-winning company with a focus on knowledge.

Our promise to you:

  • We provide an environment for growth within the life sciences industry.
  • We foster a joyful community where individuality is celebrated for collective growth.
  • Experience the JPEG at QbD: Joy in Partnership, going the Extra mile to Get things done.

Interested? Send us your CV and motivation letter to join the QbD family



  • Antwerpen, Flandre, Belgique Regulatory affairs Temps plein

    QbD Belgium Regulatory affairs Table of Contents At QbD our RA Services go from regulatory strategy, clinical, technical file to Vigilance. We support from idea to commercialization. Do you want to support companies throughout the entire medical device regulatory lifecycle? Do you want to guide them through complex regulatory requirements? This...


  • Antwerpen, Flandre, Belgique Regulatory affairs Temps plein

    RA The UK Regulatory affairs Table of Contents The UK team of the international QbD group, is a specialist regulatory and pharmacovigilance consultancy company. Our services consist in providing consultation throughout product development, regulatory approval, market launch, and into life cycle management. We have been offering support to life...


  • Antwerpen, Flandre, Belgique Regulatory affairs Temps plein

    RA Austria Regulatory affairs Table of Contents QbD Austria , part of the international QbD group, is a young and growing consulting company offering services and training on regulatory affairs, regulatory compliance, business organization and quality assurance in the pharmaceutical, food supplement and medical device industry. Our headquarters...


  • Antwerpen, Flandre, Belgique Regulatory affairs Temps plein

    Qarad Belgium Regulatory affairs Table of Contents Qarad, part of the QbD group, is a fast-growing consultancy company assisting manufacturers of In Vitro Diagnostics (IVD) and Medical Devices (MD) in coping with European and other regulations. Our objective is to provide manufacturers with practical solutions in the area of regulatory affairs...

  • RA Specialist China

    il y a 1 semaine


    Antwerpen, Flandre, Belgique Regulatory affairs Temps plein

    RA Austria Regulatory affairs Table of Contents QbD Austria , part of the international QbD group, is a young and growing consulting company offering services and training on regulatory affairs, regulatory compliance, business organization and quality assurance in the pharmaceutical, food supplement and medical device industry. Our headquarters...

  • Regulatory Affairs Consultant

    il y a 3 semaines


    Antwerpen, Flandre, Belgique Randstad Temps plein

    Ben jij een ervaren Regulatory Affairs Specialist met een passie voor het waarborgen van naleving van regelgeving binnen de life sciences industrie? Wij zijn op zoek naar getalenteerde professionals die onze organisatie kunnen vertegenwoordigen bij bedrijven in ons Randstad netwerk in Antwerpen en Kempen.Als Regulatory Affairs Specialist in Life Sciences ben...


  • Antwerpen, Flandre, Belgique Randstad Temps plein

    Ben jij een ervaren Regulatory Affairs Specialist met een passie voor het waarborgen van naleving van regelgeving binnen de life sciences industrie? Wij zijn op zoek naar getalenteerde professionals die onze organisatie kunnen vertegenwoordigen bij bedrijven in ons Randstad netwerk in Antwerpen en Kempen.Als Regulatory Affairs Specialist in Life Sciences ben...

  • Expert IVD

    il y a 1 semaine


    Antwerpen, Flandre, Belgique Regulatory affairs Temps plein

    Qarad Belgium Regulatory affairs Table of Contents Qarad, part of the QbD group, is a fast-growing consultancy company assisting manufacturers of In Vitro Diagnostics (IVD) and Medical Devices (MD) in coping with European and other regulations. Our objective is to provide manufacturers with practical solutions in the area of regulatory affairs...

  • Senior Expert IVD

    il y a 1 semaine


    Antwerpen, Flandre, Belgique Regulatory affairs Temps plein

    RA Belgium Regulatory affairs Table of Contents Qarad, part of the QbD group, is a fast-growing consultancy company assisting manufacturers of In Vitro Diagnostics (IVD) and Medical Devices (MD) in coping with European and other regulations. Our objective is to provide manufacturers with practical solutions in the area of regulatory affairs and...

  • Regulatory Affairs

    il y a 1 semaine


    Antwerpen, Flandre, Belgique Science Talents Temps plein

    Introduction:The vision of our client is to be the most responsible animal health company where employees, experts, partners and customers create togheter customizes animal health solutions for a better planet. Currently they are looking for a Regulatory Affairs & Quality Manager.The main purpose of this position is to contribute to the local management of...

  • Regulatory Affairs Manager

    il y a 1 semaine


    Antwerpen, Flandre, Belgique Flanders Temps plein

    VacancyFlen Health is an international family-owned company with ambitious growth plans in the pharmaceutical and medical device markets. We have a range of products for wound and skin care, several new products in the pipeline and research cooperation agreements in Europe and the USA. At Flen Health, we focus on people with topical inflammatory and...


  • Antwerpen, Flandre, Belgique Draslovka Temps plein

    Job Summary:Job description: The primary responsibility is to work with local evaluating competent authorities and with the European registration authorities (ECHA & EFSA) to register and gain approval of biocidal and pesticidal active substances, products and emergency authorisation permits for EU markets. The person must have strong knowledge and...


  • Antwerpen, Flandre, Belgique QBD Temps plein

    RA Belgium, The Netherlands, The UK Table of Contents QbD's team offers knowledge & tailored (software) solutions in development, clinical, regulatory & compliance, production and distribution for companies active in Pharma, Biotech and Medical Devices/IVD. Our Regulatory Affairs division supports customers throughout the entire regulatory...


  • Antwerpen, Flandre, Belgique Elanco Tiergesundheit AG Temps plein

    Regulatory Affairs Manager Benelux page is loaded Regulatory Affairs Manager Benelux Apply locations BE - Antwerp time type Full time posted on Posted 30+ Days Ago job requisition id R As a leading global animal health company, Elanco delivers innovative products and services to improve the health of pets and farm animals around the world because we...


  • Antwerpen, Flandre, Belgique Beaulieu International Group Temps plein

    On top of the regulatory trends? A heart for sustainability? So do we Let's grow together.Main responsibilities and key tasks As part of the regulatory team, ensuring our complete product offering is compliant with the relevant legislation. As part of a multifunctional project team, provide regulatory input on new product developments. Alert the business on...


  • Antwerpen, Flandre, Belgique APWIP Belgium Temps plein

    Primary Responsibilities: Develop and execute a global regulatory and public affairs strategy aligned with business objectives and growth plans, that includes, government affairs and public relations. Lead government lobbying efforts to advocate for favorable regulatory environments that align with the company's goals and objectives. Establish and maintain...


  • Antwerpen, Flandre, Belgique Johnson & Johnson Temps plein

    Johnson & Johnson Innovative Medicine is recruiting for CMC Regulatory Affairs Senior Associate. This role is located in Beerse, Belgium, and is primarily on-site with hybrid possibilities.At Johnson & Johnson Innovative Medicine, what matters most is helping people live full and healthy lives. We focus on treating, curing, and preventing some of the most...


  • Antwerpen, Flandre, Belgique Akkodis Temps plein

    Position description Category OPERATIONS - ENGINEERING/PRODUCTION Job title Regulatory Affairs Consultant Contract Permanent contract Job description ABOUT US Akkodis is an international engineering consulting and R&D services company. As an innovation accelerator for its clients, Akkodis supports leading industry players in the...


  • Antwerpen, Flandre, Belgique DESCROES Temps plein

    FunctieomschrijvingOns bedrijf is op zoek naar een specialist inzake Product Regulaties voor Fumiganten om ons team in Europa te versterken. De gekozen kandidaat zal verantwoordelijk zijn voor het beheer van productregistraties van biociden en pesticiden en de naleving van de regelgeving in overeenstemming met de Europese regelgeving.Functieomschrijving:- De...

  • Regulatory Specialist

    il y a 1 semaine


    Antwerpen, Flandre, Belgique Maandag Temps plein

    **Over de functie**:De verantwoordelijkheden van de Science** Regulatory Specialist** omvatten het ontwikkelen en verstrekken van wereldwijd regelgevend advies, met als doel commerciële kansen te optimaliseren en tegelijkertijd de reputatie van het bedrijf te behouden. Daarnaast leidt de Science** Regulatory Specialist **wetenschappelijke en regelgevende...