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Head of Regulatory Affairs Operations (m/w/d) (DE)

[5413]
Head of Regulatory Affairs

Our client’s mission is to make exceptional, innovative biopharmaceuticals to improve the lives of patients suffering from serious diseases. Innovative technologies and smart development strategies are central to our approach. Success is created by our people, who focus on excellence in all they do, collaborate closely across disciplines. Our client is driven by a desire to make the medicines of tomorrow a reality. Guided by mutual respect and trust, each member of the team is given the opportunity to develop and flourish within this exciting and inspiring environment.  We are searching for a Head of Regulatory Affairs Operation (m/w/d) Ihre Aufgaben ·Design, implement, and provide continuous improvement of regulatory systems and processes striving for operational regulatory excellence, articulated around the four pillars of Regulatory Project Management, Business Operations, Vendor Management and Information Management Systems.  ·Define global processes to ensure compliance with the regulation. Build regulatory policies and procedures and ensure that these processes are adhered to.  ·Work closely with internal stakeholders to establish Regulatory Information Management (RIM) systems and databases for the archival of all regulatory information and documentation; monitor and track on an on-going basis key regulatory affairs metrics and compliance indicators globally.  ·Regulatory Project Management: lead project managementactivities related to the preparation and tracking of regulatory documents/submissions.  ·Interface with the companies IT, QA and R&D departments(i.e. medical writing, CMC, non clinical...) and with external partners (if applicable) on local regulatory system issues management.  ·Support optimization of publishing best practices and global submission standards in accordance with regulatory requirements worldwide.  ·Represent Regulatory Operations on global regulatory subteam and drive timelines and deliverables related to submission documents. Build and maintain relationship with internal and external (e.g. DMS, publishing) vendor partners.  ·Support system audit and/or GxP inspection or due diligence with regard to regulatory systems and regulatory documentation.  ·Active participant of the global Regulatory Affairs Leadership Team.  ·Provide support, guidance and mentoring to regulatory operation team members. Ihre Qualifikationen ·Experience in the pharmaceutical industry with several years of experience and broad knowledgein the field of Regulatory Operations, Project Management, Regulatory Information and System Management  ·Experience in defining and implementation of new working standards and related regulatory processes  ·Understanding of regulatory operational landscape, esp. with regard to systems, standards and processesrelated to clinical trials, regulatory affairs, marketing authorization application.  ·Knowledge of electronic document management systems, databases and publishing systems as well as related technologies applicable to regulatory affairs  ·Self-motivated, flexible and creative leader, able to prioritize, multi task and work in a fast-paced and demanding environment.  ·Ability to analyze problems, identify alternative solutions and implement recommendations for resolution  ·Strong organizational and project managementskills. Experience in managing small projects with demonstrated effectiveness working in multidisciplinary teams  ·Excellent written and verbal communication, especially presentation and facilitation skills  ·Good leadership, interpersonal and influencing skills with demonstrated ability to mentor, and develop others.  ·Deep project management expertise with demonstrated capability too manage project and budget under short timelines. Für weitere Fragen steht Ihnen gerne Herr Tilman Grumbd unter der Rufnummer +49 441 21879-34 oder via E-Mail an tilman.grumbd@optares.de zur Verfügung.

Our client’s mission is to make exceptional, innovative biopharmaceuticals to improve the lives of patients suffering from serious diseases. Innovative technologies and smart development strategies are central to our approach. Success is created by our people, who focus on excellence in all they do, collaborate closely across disciplines. Our client is driven by a desire to make the medicines of tomorrow a reality. Guided by mutual respect and trust, each member of the team is given the opportunity to develop and flourish within this exciting and inspiring environment. 

We are searching for a

Head of Regulatory Affairs Operation (m/w/d)

Ihre Aufgaben
  • Design, implement, and provide continuous improvement of regulatory systems and processes striving for operational regulatory excellence, articulated around the four pillars of Regulatory Project Management, Business Operations, Vendor Management and Information Management Systems. 
  • Define global processes to ensure compliance with the regulation. Build regulatory policies and procedures and ensure that these processes are adhered to. 
  • Work closely with internal stakeholders to establish Regulatory Information Management (RIM) systems and databases for the archival of all regulatory information and documentation; monitor and track on an on-going basis key regulatory affairs metrics and compliance indicators globally. 
  • Regulatory Project Management: lead project managementactivities related to the preparation and tracking of regulatory documents/submissions. 
  • Interface with the companies IT, QA and R&D departments(i.e. medical writing, CMC, non clinical...) and with external partners (if applicable) on local regulatory system issues management. 
  • Support optimization of publishing best practices and global submission standards in accordance with regulatory requirements worldwide. 
  • Represent Regulatory Operations on global regulatory subteam and drive timelines and deliverables related to submission documents. Build and maintain relationship with internal and external (e.g. DMS, publishing) vendor partners. 
  • Support system audit and/or GxP inspection or due diligence with regard to regulatory systems and regulatory documentation. 
  • Active participant of the global Regulatory Affairs Leadership Team. 
  • Provide support, guidance and mentoring to regulatory operation team members.

Ihre Qualifikationen

  • Experience in the pharmaceutical industry with several years of experience and broad knowledgein the field of Regulatory Operations, Project Management, Regulatory Information and System Management 
  • Experience in defining and implementation of new working standards and related regulatory processes 
  • Understanding of regulatory operational landscape, esp. with regard to systems, standards and processesrelated to clinical trials, regulatory affairs, marketing authorization application. 
  • Knowledge of electronic document management systems, databases and publishing systems as well as related technologies applicable to regulatory affairs 
  • Self-motivated, flexible and creative leader, able to prioritize, multi task and work in a fast-paced and demanding environment. 
  • Ability to analyze problems, identify alternative solutions and implement recommendations for resolution 
  • Strong organizational and project managementskills. Experience in managing small projects with demonstrated effectiveness working in multidisciplinary teams 
  • Excellent written and verbal communication, especially presentation and facilitation skills 
  • Good leadership, interpersonal and influencing skills with demonstrated ability to mentor, and develop others. 
  • Deep project management expertise with demonstrated capability too manage project and budget under short timelines.
Für weitere Fragen steht Ihnen gerne Herr Tilman Grumbd unter der Rufnummer +49 441 21879-34 oder via E-Mail an tilman.grumbd@optares.de zur Verfügung.

map Planegg, Deutschland date_range 28.02.2022 update Permanent
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