Vacatures
>
Wavre

    Regulatory Manager - Wavre, België - Parexel

    Parexel
    Parexel Wavre, België

    6 dagen geleden

    Default job background
    Voltijd
    Beschrijving

    When our values align, there's no limit to what we can achieve.

    Are you an experienced regulatory professional looking for a new opportunity? We are currently seeking a talented CMC Regulatory Manager (Regulatory Affairs Consultant) to join our dynamic team This is a client dedicated project, and the role can be office or home based in various European locations.

    As the CMC Regulatory Manager, you will play a vital role in our company's worldwide post-approval regulatory activities, specifically focused on Chemistry, Manufacturing, and Controls (CMC) for biological products.

    Primary Tasks & Responsibilities:

  • Develop submission strategies and plans for post-approval CMC activities such as variations, renewals, market expansions, and annual reports.
  • Assess change controls and provide regulatory assessments of quality changes in production and quality control.
  • Review study reports from the quality control and production departments to ensure compliance with regulatory requirements.
  • Coordinate submission preparation with various departments including manufacturing, supply chain, quality control and quality assurance, and other regulatory departments and local companies.
  • Write and/or review submission content to ensure alignment with regulatory requirements, specifically related to variations and questions from health authorities.
  • Manage projects within all Regulatory Information Management systems, ensuring the maintenance of worldwide submissions.
  • Identify, escalate, and mitigate risks associated with regulatory procedures and activities.

    • Experience and Knowledge Requirements:

  • University-level education, preferably in Life Sciences, or equivalent by experience.
  • Previous experience in regulatory affairs, particularly related to technical/CMC/quality, within the pharmaceutical industry.
  • Strong understanding of CMC and post-approval regulatory requirements.
  • Experience in writing CMC (technical) sections of regulatory documents such as registration files or variations.
  • Knowledge of biological processes.
  • Background in validation/Quality Assurance/production in the pharmaceutical industry, with experience in preparing regulatory documentation. Understanding of qualification/validation principles.
  • Proficiency in Word, PowerPoint, Excel, and experience with Veeva Vault is valued.
  • Team spirit, flexibility, accountability, and organizational skills.
  • Fluent in English (written and spoken). French, Italian and German would be a strong plus.
  • VDMA e. V.

    Regulatory Manager

    1 week geleden

    VDMA e. V. Brussels, België

    **Zukunft** · **gemeinsam gestalten** · **Der VDMA vertritt mehr als 3600 deutsche und europäische Unternehmen des Maschinen · - und Anlagenbaus. Die Industrie steht für Innovation, Exportorientierung und Mittelstand. Die Unternehmen beschäftigen insgesamt rund 3 Millionen Mensch ...

  • GSK

    Regulatory Manager, Global Regulatory Affairs

    1 week geleden

    GSK Wavre, België

    **Site Name**: Belgium-Wavre, GSK House, Italy - Siena · **Posted Date**: Jan · As Manager Global Regulatory Affairs, you will have global responsibility (for Regulatory Affairs) of given activities for Measles, Mumps, Rubella, and Varicella (MMR/V) Live Viral Vaccines lifecycle ...

  • GSK

    Regulatory Portfolio Manager

    1 dag geleden

    GSK Wavre, België

    **Site Name**: Upper Providence, GSK House, Wavre · **Posted Date**: Jan · Are you interested in a project management role that allows you to accelerate regulatory compliance across the business? If so, this Regulatory Portfolio Manager could be an ideal opportunity to explore. ...

  • GSK

    Regulatory Project and Data Manager

    1 dag geleden

    GSK Wavre, België

    **Site Name**: UK - London - Brentford, Belgium-Wavre · **Posted Date**: Feb · **Regulatory Project and Data Manager** · You will work alongside a more senior Regulatory Portfolio Manager to create the RDPs, after which you will work independently to maintain the plans, ensuring ...

  • GSK

    Regulatory Project and Data Manager

    1 dag geleden

    GSK Wavre, België

    **Site Name**: UK - London - Brentford, Belgium-Wavre · **Posted Date**: Feb · **Regulatory Project and Data Manager - 1 Year FTC** · You will work alongside a more senior Regulatory Portfolio Manager to create the RDPs, after which you will work independently to maintain the pl ...

  • GSK

    Global Regulatory Submission Manager

    4 dagen geleden

    GSK Wavre, België

    **Site Name**: GSK House, Belgium-Wavre, Italy - Siena, Siena, Wavre · **Posted Date**: Aug 9 2023 · This is an excellent opportunity for either an established Project Manager in the Life Sciences industry or Regulatory Affairs professional looking to join a truly global team/rol ...

  • KBC

    Regulatory Product Manager

    2 dagen geleden

    KBC Brussels, België

    **Contractvorm**: · - Onbepaalde duur · **Werkregime**: · - Voltijds · **Locatie**: · - Brussel, Vlaams-Brabant · **Ervaringsniveau**: · - Senior (> 5 jaar) · **Wat houdt deze vacature in?**: · In de realisatie en verdere ontwikkeling van onze strategie hechten we veel belang aan ...

  • GSK

    Sr Manager, Global Regulatory Affairs

    4 dagen geleden

    GSK Wavre, België

    **Site Name**: USA - Maryland - Rockville, Belgium-Wavre, Italy - Siena, Philadelphia Navy Yard, UK - United Kingdom · **Posted Date**: Jul · Are you interested in a highly visible US regulatory affairs role that allows you to drive strategy and shape integrated regulatory devel ...

  • GSK

    Senior Manager, Global Regulatory Affairs

    1 dag geleden

    GSK Wavre, België

    **Site Name**: Belgium-Wavre, GSK House, Italy - Siena · **Posted Date**: Jan · As Senior Manager, Global Regulatory Affairs, you will have global responsibility (for Regulatory Affairs) of given activities for a Project/Product within GSK Vaccines. · The purpose of the job is t ...

  • GSK

    Non-clinical Regulatory Project Manager

    2 dagen geleden

    GSK Wavre, België

    **Site Name**: UK - Hertfordshire - Ware RD, Belgium-Wavre, GSK House, USA - Pennsylvania - Upper Providence · **Posted Date**: Aug · An opportunity has arisen to join the Nonclinical Regulatory affairs team. You will be responsible for the nonclinical regulatory activities in t ...

  • GSK

    Senior Manager Regulatory Affairs, Grl Delegate

    1 week geleden

    GSK Wavre, België

    **Site Name**: Belgium-Wavre · **Posted Date**: Mar · As a Senior Manager Regulatory Affairs, GRL Delegate, you will have global responsibility (for Regulatory Affairs) for the development and lifecycle activities related to pneumococcal vaccines**.** · This role will provide YO ...

  • NSF International

    Manager, Regulatory Affairs

    1 week geleden

    NSF International Zaventem, België

    Regulatory Affairs Manager EMEA · At NSF International, our mission is to protect and improve human health. We're a global leader in standards development, testing, auditing, certification and training. We provide these services for a diverse set of industries including food, wat ...

  • Pfizer

    Regulatory Affairs Manager

    4 dagen geleden

    Pfizer Elsene, België

    (Senior) Regulatory Affairs Manager · Why Patients Need You · Pfizer is the world's premier biopharmaceutical company taking new approaches to better health. We discover, develop, manufacture and deliver quality, safe and effective prescription medicines to treat and help prevent ...

  • Medpace, Inc.

    Regulatory Submissions Manager

    1 week geleden

    Medpace, Inc. Leuven, België

    Job Summary: · Our clinical operations activities are growing rapidly, and we are currently seeking a full-time Regulatory Submissions Manager to join our Clinical Operations team in Leuven, Belgium. This position plays a key role in the clinical trial management process at Medpa ...

  • VDMA

    Regulatory Manager

    1 week geleden

    VDMA Brussels, België Voltijd

    Standort: Brüssel · Die Fachverbände Druck- und Papiertechnik sowie Sicherheitssysteme vertreten als Sprachrohr die Interessen von rund Mitgliedern aus Deutschland und Europa, insbesondere mittelständische Familienunternehmen aus dem Bereich der herstellenden Industrie. Die Fachv ...

  • Medpace, Inc.

    Regulatory Submissions Manager

    1 week geleden

    Medpace, Inc. Leuven, België

    Job Summary: · Our clinical operations activities are growing rapidly, and we are currently seeking a full-time Regulatory Submissions Manager to join our Clinical Operations team in Leuven, Belgium. This position plays a key role in the clinical trial management process at Medpa ...

  • Equals Money

    Regulatory Compliance Manager

    1 week geleden

    Equals Money Brussels, België

    **_Who we are_** · Over the last 16 years, Equals Money has helped over a million satisfied customers move and manage their money. Our award-winning product portfolio allows our customers to make low-cost multi-currency payments across various payment products. From travel money ...

  • UCB S.A.

    Regulatory Submission Manager

    4 dagen geleden

    UCB S.A. Anderlecht, België

    **Make your mark for patients** · We are looking for a **Regulatory Submission Manager **to join us in our **Regulatory Affairs** team, based in either our **Brussels** (Belgium) or **Slough** (UK) offices. · **About the role** · The Submission Manager will be responsible for wor ...

  • STADA Arzneimittel AG

    Regulatory Affairs Manager

    5 dagen geleden

    STADA Arzneimittel AG Brussels, België

    **About EG** · - EG is a Purpose driven company: at the core of everything we do, we aim to Care for People ́s Health as a Trusted Partner.- EG is also the largest pharmaceutical company in Belgium. With an offering for just about every therapeutic area, we are the market leader ...

  • Sunfire

    Manager Regulatory Affairs

    5 dagen geleden

    Sunfire Brussels, België

    YOUR TASKS · **WHAT TO EXPECT?** · **Monitoring** · You wil monitor relevant developments in energy policy and regulation that impact on Sunfire's business and strategy. · **Advocacy** · You will prepare and share regulatory analyses, develop position papers and proactively influ ...