Global Pharmaceutical Manufacturer seeks an experienced Regulatory Operations Manager.
Duties may include
Lead the Operations team responsible for Extended EudraVigilance Medicinal Product Dictionary (xEVMPD) (Article 57) submissions to ensure compliance with current regulations
Respond to Health Authority queries on xEVMPD data as required and reconcile xEVMPD data with the Affiliates as required
Provide expertise during xEVMPD audits / inspections and support the process by providing reports and responding to queries as requested
Generate, monitor and ensure adherence to compliance metrics and Key Performance Indicators. Provide reports to senior leadership / stakeholders and escalate issues as needed.
Coordinate Annual PV Fee Advice Note review with EEA Affiliates, ensuring any corrective actions have been made in the xEVMPD database as instructed by the Affiliates.
Manage xEVMPD data requests. Generate the reports, analyze the data and distribute to appropriate stakeholders.
Maintain Standard Operating Procedures, Work Instructions, Job Aides, etc. as appropriate for relevant business processes and systems
Maintain an in-depth knowledge of xEVMPD, IDMP, SPOR, TOM, etc.; participate in external working teams (Health Authorities, Industry Forums, etc.
Communicate changes to ensure RIMS Steering Committee and other key stakeholders are kept well informed of any potential impacts.
Identify training opportunities and provide mentoring and support to ensure the team is appropriately developed in accordance with their roles and responsibilities.
Manage objective setting, contribute to career development plans and skill development for direct reports and ensure appropriate performance assessments.
Support internal project teams to identify and resolve issues while developing opportunities to reduce inefficiencies through new and / or improved IT solutions, business processes or tools.
Collaborate effectively across different organizational levels and functions to realize the primary goal of One Global Regulatory Standard.
Skills and experience :
Minimum of a bachelor's degree (or equivalent) and extensive experience in the pharmaceutical industry (Regulatory Affairs, Operations).
In-depth knowledge and understanding of pharmaceutical science processes and standards, including xEVMPD, ISO IDMP, SPOR, Standard Terms / Referentials, regulatory dossier lifecycle, etc.
Experience using and administrating xEVMPD submission in-house applications.(e.g. GxPD, Virtify, etc.)
People leadership experience desirable
Ability to work in a highly cross functional team environment.
Must possess excellent attention to detail and propensity to learn.
Must be proficient in Microsoft Word and Excel.
Frequent business travel or working at other locations may be required
Role : Regulatory Operations Manager
Job Type : Permanent
Location : Hertfordshire,
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