Global Regulatory Compliance Manager

€60 - €75 per hour
  1. Interim/Contract
Belgium
  1. Regulatory Affairs, CMC
Posted:30/04/2021
BBBH16459

Hobson Prior are looking for a Global Regulatory Compliance Manager to join a global pharmaceutical organisation whose values is to change the lives of patients who have debilitating disease. The role will be on a 5 month contract basis.

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

Job Responsibilities:

  • Maintaining status oversight on Regulatory-related Deviations & related CAPA assigned to the GRA Practice.
  • Maintaining status oversight on Audit Observations & related CAPA status assigned to the GRA Practice.
  • Monitoring Global Regulatory indicators for status and effectiveness.
  • Analysing Regulatory-related Deviations for trending.
  • Analysing Audit/Inspection observations related to Regulatory activities for trending.
  • Coordinate creation and maintenance of Policies, Standard Operating Procedures and standards supporting the GRA activities.
  • Support maintenance of Job Descriptions and CVs across the GRA Practice.
  • Support maintenance of and compliance to training plans for the GRA Practice.
  • Identify deviation event and facilitate the Regulatory-related Deviation investigation.
  • Manage TrackWise process for Regulatory-related Deviations & CAPA.
  • Collaborate with Deviation Owners to ensure appropriate documentation of the Deviations.
  • Follow-up with CAPA owner to ensure timely approval and closure.
  • Support Audit & Inspection-readiness activities.
  • Collaborate with Audit/Inspection Observations owners and related CAPA owners by providing support to facilitate timely resolution and closure.
  • Participate to compliance's risk mitigation and process improvement initiatives in collaboration with all the concerned parties within and outside the GRA Practice.
  • Build & maintain expertise, oversight & network through projects.
  • Share information within the GRA Practice to foster Compliance.
  • Participate to workshops & organize meetings/trainings with stakeholders.

Skills:

  • Good presentation and training skills.
  • Good analytical and investigation skills.
  • Project management skills; excellent planning and organizational skills.

Requirements:

  • Educated at Bachelor's Degree, Master's Degree or even a Ph.D.
  • At least 6 years of relevant experience in the pharmaceutical industry, with preferably 4 years in Regulatory Affairs and/or and Quality Assurance within the Pharmaceutical industry.
  • Experience of working in a multicultural environment.
  • Experience in Regulatory Compliance.
  • Regulatory audits and inspections experience is an asset.

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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