Regulatory Affairs and Quality - Slough, United Kingdom - IPSEN

IPSEN
IPSEN
Verified Company
Slough, United Kingdom

2 weeks ago

Tom O´Connor

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Tom O´Connor

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Description

Title:

Regulatory Affairs and Quality (RQ) Officer


Company:

Ipsen Ltd

Ipsen is a dynamic and growing global specialty-driven biopharmaceutical company focused on innovation and specialty care.


We aim to make a sustainable difference by significantly improving patients' health and quality of life and providing them with effective therapeutic solutions for unmet medical needs through differentiated and innovative medicines in Oncology, Neurosciences and Rare Diseases.


The patient is at the heart of everything we do, and we also care for our employees because they are the ambassadors who truly make the difference.

We attract and develop bold, agile, entrepreneurial individuals who take full ownership of their decisions; leaders drawn by a purpose to make a direct impact through their work in people's lives.


We offer employees a wealth of fulfilling challenges & growth opportunities, and the chance to contribute within a fast-moving organisation, an organisation that is genuinely game-changing.


The
Regulatory Affairs and Quality (RQ) Officer is a new role within the department and will be key in coordinating and bridging the activities between the two functional areas.


This role would be ideal for an individual with some experience in the pharmaceutical industry that is looking to pursue a professional career in Regulatory Affairs and/or Quality.


Your main areas of responsibility will include:

  • Life-cycle management (preparation and submission) for licenced marketed and non-marketed products
  • Management of local complaints
  • Management of controlled documents
  • Management of training
  • Provide administrative functional support for the creation and allocation of training in the electronic training system (iLearn)
  • Provide support to GxP functions in logging and progressing records in the Ipsen eQMS (Quality Connect)
  • Manage external Regulatory public domains
  • Coordinate and manage the administrative activities associated with the electronic document system (Easidoc)
  • Provide administrative support for functional archiving requirements
  • Act as Local Complaint Initiator
  • Responsible for the administrative tracking and filling associated with Product Quality Complaints
  • Manage internal RQ SharePoint, ensure information published is correct and up to date
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