Regulatory Affairs Consultant ( CTD Publishing Consultant) - Life Sciences
Altran
Brussels, BEL, Belgium
32 dagen geleden

Our offer

Altran is the global leader in innovation and high-tech engineering consulting. At Altran Belgium, you get the chance to work on projects among a multisectorial portfolio of more than 300 clients and you become part of our international community of like-minded experts!

There are many ways to make your career thrive and grow within Altran : build your career with Altran Career Path, expand your career abroad with Mov’Altran, follow your personal development plan, and be coached by senior experts.

Grow your knowledge along with your career : keep learning with the Altran Academy, seminars and Benchmark Expertise Project (BEP) sessions.

And don’t forget to have fun : we are building a strong community of consultants thanks to Altran Sport Clubs & internal social events!

Our ambition : Altran 2020. Ignition

New strategic plan sets a new horizon for the Engineering and R&D services (ER&D) market. Altran 2020. Ignition’ targets >

€3 billion revenue and best-in-class profitability through augmented value, GlobalShore industrialization, geographic expansion and operational excellence.

Key responsibilities

Altran CTD Publishing Team is in charge of regulatory publishing activities for a well know pharmaceutical company.

These activities are : preparation, validation, submission, and archiving of regulatory files (MAA, renewals, variations, PSUR, PBRER, PSUSA and answers to questions) in electronic format ( e-

CTD, Nees) or in pdf format according to the requirements of the dossier’s region ( Europe and world).

The team must ensure the compliance of the files and documents according to the applicable regulations and standards, and follow the internal procedures and the required quality standards of the client.

As CTD publishing Consultant, You :

  • participate in delivering the publishing activities : preparation, validation, submission, and archiving of regulatory files (MAA, renewals, variations, PSUR, PBRER, PSUSA and answers to questions) in electronic format ( e-
  • CTD, Nees) or in pdf format according to the requirements of the dossier’s region ( Europe and world).

    Your profile

    You are an Innovation Maker and you want to put your engineering , science and business skills to use to create solutions.

    You like to share your knowledge with likeminded engineers and you know how to take initiative .

    You have :

  • Pharmacist or paramedical degree, e.g. biotechnology, veterinary
  • At least 1 year of RA publishing EU dossiers
  • Good knowledge of preparation, publication, validation submission of regulatory dossiers in e-CTD and NEES
  • Good level of writing and speaking in Spanish
  • Experience with e-CTDmanger or other computer programmes for CTD publishing
  • Organizational skills
  • Good Communication skills
  • Flexible, conflict handling and problem-solving skills, sense of innovation.
  • Team player with sense of prioritizing workload with attention to detail
  • Familiar with MS office tools and outlook, with fast software learning skills
  • You will be recruited by Georges & Isabelle, don’t hesitate to contact them & send them your CV : -

    Discover more about your career on

    Solliciteren
    Solliciteren
    Mijn E-mail
    Door op "Doorgaan" te klikken, gaat u ermee akkoord dat neuvoo uw persoonlijke gegevens verzamelt en verwerkt die u in dit formulier hebt verstrekt, om een ​​neuvoo-account te maken en u te abonneren op onze e-mailwaarschuwingen, in overeenstemming met ons Privacybeleid . U kunt uw toestemming te allen tijde intrekken door te volgen deze stappen .
    voortzetten
    Aanvraagformulier