Center of Excellence Regulatory Lead

il y a 2 semaines


Gent, Belgique Argenx Temps plein

For the expansion of our Regulatory team, argenx is looking for a Center of Excellence Regulatory Lead who is responsible for:- managing the team of regulatory associates that performs regulatory oversight for the individual studies.

Key Accountabilities/Responsibilities:

- Maintain an in-depth knowledge of the fast-evolving global clinical trial regulations
- Develop and maintain a regulatory intelligence database to centralize hands-on knowledge on (local) regulations and internal experiences regarding clinical trial submissions
- Actively liaise with other functions involved in clinical trial submissions in order to optimize clinical trial start-up timelines
- Advise clinical trial teams during study planning, set-up and conduct
- Oversee the team of regulatory liaisons and ensure the appropriate regulatory oversight for all clinical studies
- Provide training to educate functional areas on regulatory changes and lessons learned
- Adapt and optimize processes related to clinical trial submissions to comply with new regulation(s) and gain efficiency
- Identify the need for new processes and develop these together with the relevant functional areas
- Develop, update and maintain procedural documents as needed

Desired Skills and Experience:

- Excellent communicator
- Builder of interdepartmental relations
- Working knowledge of current global clinical trial regulations
- Hands-on approach to support CTT team(s)
- Independent, quick learner
- Prioritize effectively in a fast-paced environment
- Excellent organizational skills and attention to detail
- Leadership skills and critical thinker to find solutions with the teams for various problems and make decisions
- Analytical mind to understand, analyse and optimize processes and procedures
- Highly self-motivated
- Computer literacy, proficiency in MS Word, Excel, PowerPoint, Acrobat Pro, etc
- Master degree or PhD in scientific or biomedical field
- 10+ years of experience in clinical development role (preference given to regulatory affairs)
- Deep understanding of clinical trial submission process:

- Experience in the submission and maintenance of clinical trials worldwide
- Expert in the EU Regulation 536/2014
- Experience with the US IND submission process
- Familiarity with clinical trial documents and clinical development design
- Experience in improving processes and update/create related Procedural Documents
- Experience with writing review summaries and developing training material
- Knowledge of project management

**Offer**:

- A competitive salary package with extensive benefits;
- A work environment in a successful, dynamic, rapidly growing biotech company.


  • Regulatory Liaison Eu

    il y a 4 semaines


    Gent, Belgique Argenx Temps plein

    The Regulatory Affairs team is expanding and is currently looking for a Regulatory Liaison. Purpose of the position: Assists in global regulatory activities and manages the operational aspects of regulatory filings, and other to health authorities. Supports global regulatory leader(s) in execution of project strategies. Key...

  • Head of Science Policy

    il y a 1 semaine


    Gent, Belgique VIB Headquarters Temps plein

    VIB is an entrepreneurial non-profit research institute, with a clear focus on ground-breaking strategic basic research in life sciences and operates in close partnership with the five universities in Flanders. VIB is in search for a **leader** for its **Science Policy team**, reporting to the Managing Director. **Role purpose**: Lead the Science Policy...


  • Gent, Belgique Argenx Temps plein

    For the expansion of the bioanalytical team, argenx is looking for a (Associate) Director Bioanalytics, with profound experience in late-stage drug development of large molecules. The level and title will depend on the experience of the incumbent. He/she will conduct and lead bioanalytical support in all aspects for one of the argenx indication franchises....


  • Gent, Belgique Argenx Temps plein

    Summary argenx is seeking a Global Equity Incentive Lead who will report to the Global Head of Reward & Recognition. This role involves spearheading the implementation, administration, and communication of equity-based compensation programs, including Stock Options, RSUs, ESPPs, and other equity incentives. The primary responsibilities include ensuring that...


  • Gent, Belgique Elements Advisory Temps plein

    As a Junior Regulatory Affairs Specialist, you will be responsible for assisting in the management of regulatory affairs activities related to our biocide products. You will collaborate closely with the regulatory affairs team and other cross-functional departments to ensure compliance with relevant regulations and standards. **Responsibilities**: - Assist...


  • Gent, Belgique Elements Advisory Temps plein

    As a Senior Regulatory Affairs Specialist, you will be responsible for ensuring compliance with regulatory requirements for biocide products. You will work closely with cross-functional teams, regulatory authorities, and external partners to facilitate the registration and approval processes for biocide products in different markets. Your expertise in...

  • Lead Quality Training

    il y a 1 semaine


    Gent, Belgique MindCapture Temps plein

    LEAD QUALITY TRAINING - Biotech- GhentWHAT IS OFFERED We offer strong compensation packages that reward your abilities, hard work and ingenuity in achieving success. We reward you with competitive wages and offer a strong package with additional legal benefits such as meal vouchers, eco vouchers, high health insurance (DKV) and group insurance. Depending...

  • Market Access Lead

    il y a 4 semaines


    Gent, Belgique Nuwhï Temps plein

    At Nuwhï, we collaborate with leading organizations in the healthcare industry to provide tailored recruitment solutions. With a focus on innovation and excellence, we support companies in their mission to deliver high-quality healthcare solutions. **Company summary**: A consulting company specializing in supporting pharmaceutical companies in Regulatory...

  • Regulatory Affairs Specialist

    il y a 4 semaines


    Gent, Belgique Jefferson Wells Temps plein

    Location: **Gent** **#23587** **Regulatory Affairs Specialist** Vast Contract - Regio Gent **#regulatory #affairs #specialist #food** Beschik je over een masterdiploma met een voorkeur voor een specialisatie in landbouw, voeding of chemie? Heb je min. 3 jaar ervaring in Regulatory Affairs? Ben je zelfstandig, zeer communicatief en computervaardig? Lees...

  • Mep Mechanical Lead

    il y a 2 semaines


    Gent, Belgique Brightpath Recruitment Ltd. Temps plein

    **MEP Mechanical Lead - Ghent, Belgium** - Pharma Project **Benefits Include: - Accommodation - Travel & Living Allowance - 26 days annual leave - Company vehicle & Fuel card - Pension & Health insurance - Early finish on a Friday + much more. One of Irelands longest standing Civil Engineering and Building Contractors are recruiting a MEP Mechanical Lead...


  • Gent, Belgique Ardena Temps plein

    **About us** As a leading contract development and manufacturing organization (CDMO) within the pharmaceutical industry, **Ardena** is dedicated to supporting pharmaceutical companies, from virtual biotech to major players, in bringing their valuable molecules to the clinic and market. Our commitment extends to providing a comprehensive and integrated...


  • Gent, Belgique Argenx Temps plein

    For the expansion of our EMEA team, argenx is looking for an PR/PO Operational excellence specialist. This role will report to the Finance organization. The function is based in Belgium and requires regular face-to-face interactions at the office in Ghent. Key Accountabilities and Responsibilities: Your primary areas of focus are: - Owner of procure to pay...

  • Digital Architect

    il y a 1 semaine


    Gent, Belgique BASF Belgium Coordination Center CommV Temps plein

    **JOIN THE TEAM**: **RESPONSIBILITIES**: This is your task package: - As Digital architect, you will collaborate with key stakeholders to develop a comprehensive global digital architecture strategy that supports the digital roadmap. - You will lead the design and development of scalable, secure, and robust digital architecture solutions aligned with...


  • Gent, Belgique Oxford Global Resources Temps plein

    **Manufacturing Operations Lead - Advanced Therapies**: - Location: Ghent, Belgium - Contact: Dardo Helpers - Job type: Contract - Contact phone: +32 15 445 852 - Industry: Pharmaceutical Lead the operational charge in building and scaling two innovative biological manufacturing centers, shaping the future of immunotherapy and directly impacting the...


  • Gent, Belgique Argenx Temps plein

    At argenx, we are committed to pioneering the discovery, development, and commercialization of innovative immunology therapies to transform the lives of patients worldwide. Our dynamic team operates at the forefront of biotechnology, driven by a passion for scientific excellence and a dedication to improving patient outcomes. - We are seeking a highly...


  • Gent, Belgique Oxford Global Resources Temps plein

    Location: Ghent, Belgium - Contact: Dardo Helpers - Job type: Contract - Contact phone: +32 15 445 852 - Industry: Pharmaceutical Lead the operational charge in building and scaling two innovative biological manufacturing centers, shaping the future of immunotherapy and directly impacting the trajectory of patient health **Job description** We are seeking...


  • Gent, Belgique MindCapture Temps plein

    CLINICAL OPERATIONS DEVELOPMENT LEAD - Biotech- Ghent & remoteWHAT IS OFFERED The Clinical Operations Development Lead plays a critical role in ensuring the success of clinical trials and the development of new therapeutic assets, coordinating efforts across various functions and stakeholders to drive effective clinical development strategies. Next to a...


  • Gent, Belgique MindCapture Temps plein

    FRANCHISE CLINICAL OPERATIONS DEVELOPMENT LEAD - Biotech- GhentWHAT IS OFFERED Franchise Clinical Operations Development Lead plays a critical role in overseeing the operational path for all indications within a franchise. Functioning as a line manager, and ensuring consistency to synergy across different indication teams. The Franchise Clinical Operations...

  • Head Facility Management

    il y a 1 semaine


    Gent, Belgique BASF Belgium Coordination Center Comm.V. Temps plein

    Agriculture plays a fundamental role in fulfilling many of humanity's basic needs: food, feed, energy. To support growers and those who take care of our environment, BASF develops innovative solutions for farming, pest control and landscape management - so that we can effectively contribute to improving people's lives and business' demands. Come join us on...


  • Gent, Belgique Argenx Temps plein

    The Senior Manager of Content Management will assist in the content creation efforts for the Global Medical Information function which will ensure timely and accurate responses are provided to unsolicited medical and clinical inquiries from healthcare professionals, patients, clinical sites and other healthcare organizations. This position will report to...