Regulatory Operations Specialist

Grünenthal Group

Aachen, Germany

Your responsibilities:

  • As a member of the regulatory subteam responsible to provide operational support in the planning and execution of global regulatory strategies for a product or set of products;
  • Providing full support for the dossier management, i.e. compiling regulatory submissions such as for e.g. clinical trial or marketing authorization applications, variations, renewals, PSUR submissions;
  • Coordinating all submission-relevant tasks helping to ensure that these are submitted and managed as planned. This includes activities such as dispatch and tracking of delivery/submission status, processing of invoices, legalizations, ordering of samples etc.;
  • Working flexibly within and across regions to meet business objectives and contact point for affiliates/agents for assigned responsibilities;
  • Specialist for the regulatory publishing tool and electronic submissions such as NeeS, eCTD, and performing technical quality checks for regulatory submissions;
  • Maintaining relevant data in regulatory databases;
  • Creating relevant regulatory documentation in the document management system;
  • Specialist for electronic and paper archiving;
  • Assessing trends and upcoming changes in the regulatory operational environment in terms of their impact on Grünenthal.

Your profile:

  • A life science background such as Pharmaceutical, Medicinal or biological technical assistant (PTA, MTA, BTA);
  • Preferably experience in the field of Regulatory Affairs, especially knowledge of publishing tools, e-submission tools and databases;
  • Good knowledge of English, Spanish beneficial;
  • Good knowledge of MS Office, document management systems;
  • Ability to work on multiple tasks simultaneously;
  • Very structured and attention-to-detail working style, flexible and pragmatic where needed;
  • Independent, reliable and proactive;
  • Strong in teamwork;
  • International/ intercultural working skills beneficial;
  • Open, flexible and adaptable personality.

For more details and to apply for this job click here

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