RA Process Lead - Consultant

Proclinical is currently seeking a Global Regulatory Affairs of the Global Product Strategy group for its client located remotely. Successful candidate will be the continuous improvement resource in the respective Global Regulatory Affairs, Function Global Product Strategy, and will become the Process Lead for the key GRA end-to-end processes.

Job Responsibilities:

• Managing Phase I to IV Studies.
• Administering Marketing Authorization Applications.
• Overseeing Orphan Drug Applications.
• Defining and agree the vision for the processes, the strategic goals, and a strategic roadmap to achieve these goals.
• Leading the implementation of the necessary transformation projects within the roadmap, for the entire required capability, using leading practices where possible.
• Establishing governance for the process in line with CSL global standards and GRA Process Governance.
• Establishing and execute continuous improvement for the processes, as defined by the GRA Process Governance.
• Managing ongoing changes to the processes and associated technology. Ensure that the process is kept up to date in the process management system.
• Contributing to the required change management initiatives to successfully implement the process and achieve operational excellence.
• Facilitating regular reviews of Training Matrix /correct training assignment within the function for both GRA and CSL SOPs.
• Identifying quality and compliance gaps and enters them into a log/system (including non-conformances), supports follow up activities.
• Supporting GRA Quality Compliance when performing compliance effectiveness checks, incl. CAPA effectiveness checks and Root Cause Analyses.

Skills and Requirements:

• BA/BS, MA/MS, or equivalent.
• Professional certifications: Certified Process Management (CBPP/CBPMP) or Certified compliance and ethics Professional (CCEP) are an advantage.
• Ten plus years of experience in information management processes. Experience in compliance management, regulatory affairs and project management are an advantage.
• Experience in managing cross functional activities and working in matrix organization.
• Excellent analytical skills.
• Ability to bring global perspective and holistic view.
• Highly effective communicator with written, verbal and presentation skills in English.
• Ability to deal with a rapidly changing environment.
• Ability to handle multiple projects simultaneously.
• Ability to assess situations regarding appropriateness of working independently versus seeking guidance from supervisor and proactively share information with peers and generate discussion to resolve complex issues.
• Strong interpersonal skills in a multicultural environment.

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.

In case you have difficulty in applying or if you have any questions, please call Nicholas Walker at (+1) 646-367-2908 or upload your resume on our website - www.Proclinical.com.

A full job description is available on request.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

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