Regulatory Data Entry Programme Manager

Negotiable
  1. Permanent
Paris, Île-de-France
  1. Regulatory Affairs, Development
Posted:30/04/2021
BBBH16445

Hobson Prior are currently working with a worldwide specialty-driven biotech company who are looking for a Regulatory Data Entry Programme Manager motivated to join them on a permanent basis.

Please note that to be considered for this role you must have the right to work in this location.


Job Responsibilities
:

  • To propose improvements to the regulatory tracking system and relative documentation based on daily use.
  • Managing the update of the Regulatory System, internally or with Service Providers.
  • Assists the regulatory system owners with their system enhancement projects.
  • To ensure that accurate and up-to-date regulatory information on products, under development, approved and marketed, worldwide is available to all stakeholders.
  • Contribute to the maintenance of quality documentation.
  • Contribute to the Regulatory Tracking System governance.
  • You will ensure accuracy of metadata to be submitted to the health Authority.
  • Responsible for managing the creation of objects in Regulatory Tracking System and its cleansing, internally or with Service Providers.
  • Responsible to attend any RA project management meeting to be updated of any regulatory activity in relation to allocated products.
  • Assess the impact of the Submission strategy on Regulatory Tracking System in collaboration with GRA.
  • Contributes to the improvement of regulatory data entry process in performing pilot tests key stakeholders.
  • Ensuring Data Entry execution according to timelines.
  • Maintain the metadata collection tool in line with regulatory tracking system evolution.
  • Maintain up-to-date instruction, internal guide relating to the Data Entry activity.
  • Any other duties assigned.

Key Skills:

  • Good written and oral communication skills.
  • Robust project management skills.
  • Collaborative and Team Spirit mindset

Requirements:

  • To be Educated at a degree in Life Science or Pharmacy.
  • At least 2 years' experience in Regulatory affairs and submission, with Corporate experience.
  • At least of 4 years' experience in Submission coordination and Regulatory metadata management.
  • Strong skills in standard software packages, and RIM (Regulatory Information Management) tool.
  • Excellent English if not mother tongue.
  • Previous experience in EU, US and Intercontinental Regulatory Submissions.
  • Previous experience in centralized data entry organisation.
  • To be fluent in French language.

Apply now:

If you are interested in learning more or applying to this exciting opportunity then please click "Apply" and upload a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist directly, please select "Contact me" at the top of this page.

Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.

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