• This role offers an excellent opportunity for professional growth
• Joining this company will allow you to contribute to impactful project

Sobre o nosso cliente

Our client is a global healthcare company committed to improving access to high-quality medicines and healthcare solutions worldwide. The Senior Specialist, Global Regulatory Operations Key Initiatives, will be responsible for leveraging their SME regulatory knowledge to proactively stay informed of key regulatory initiatives across the globe, with a particular focus on pan-European regulations. This will include conducting detailed impact assessments and change management activities related to Regulatory business processes and systems, ensuring they remain fit for purpose and that all changes are effectively communicated to relevant stakeholders.

Descrição

• Stay proactively informed of key regulatory initiatives across the globe, with a specific focus on pan-European regulations including structured data initiatives such as ePI, eCTD 4.0, and with a primary focus on IDMP implementation;
• Lead collaboration efforts across business functions to build relationships and identify the owners of data sources, with an initial focus on ISO IDMP;
• Partner with data owners, provide SME input to identify and source the data points required for IDMP on an ongoing basis, and manage the establishment of data QC processes;
• Develop a thorough working knowledge (in support of data mining) of organizational systems that are used to author, store and track regulatory information within the scope of regulatory initiatives;
• Collate information, provide guidance and populate IDMP-specific templates in support of data enrichment for both the internal Regulatory Information Management (RIM) system and the EMA's Product Management Services (PMS) database;
• Prioritize data discrepancies and concerns, propose solutions and raise issues for discussion with the manager to ensure visibility and resolution;
• Lead efforts to establish new business processes and update existing processes in support of regulatory initiatives, identifying clear RACI (Responsible, Accountable, Consulted and Informed) roles to ensure effective hand-offs, ownership and QC;
• Contribute to the development and implementation of departmental Standard Operating Procedures (SOPs), user manuals and data standards;
• Support change management activities to facilitate the implementation of strategic and complex initiatives, transitioning from the current state to the future state;
• Maintain an in-depth knowledge of xEVMPD, IDMP, SPOR, eCTD 4.0, etc., working closely with the manager and colleagues in Regulatory Operations, RIM, xEVMPD and Publishing teams;
• Attend industry- and Health Authority-led webinars, ensuring timely internal communication of relevant updates;
• Partner with the Master Data Management team and provide SME input with respect to the submission of master data requests for dictionary updates to the RIM system in alignment with Health Authority requirements;
• Provide hands-on support for data mapping requirements for RIM-controlled values to agency-defined values. Responsible for coordinating the resolution of data discrepancies and misalignments;
• Propose improvements to the RIM system, processes or procedures based on experience with the system and an understanding of evolving requirements;
• Work in conjunction with the Learning and Development team to provide input supporting the creation of training and educational materials, as well as the delivery of targeted training to business teams;
• Partner with the Regulatory Operations team to collaborate across business functions to identify opportunities for data alignment, reporting and/or system integration.

Perfil ideal

• Must have a thorough knowledge of the European Medicines Agency (EMA), European Union (EU) procedures, EudraVigilance Medicinal Product Dictionary (XEVMPD) and a good working knowledge of Identification of Medicinal Products (IDMP) and Substance, Product, Organisation & Referentials (SPOR);
• Experience in Regulatory Information Management Systems and eCTD backbone structure;
• Ability to read and interpret complex business and/or technical documents, in particular labelling documents (Summary Product Characteristics; SMPCs) and modules 1, 2 & 3 of eCTD;
• Must be proficient in Microsoft Word and Excel. Experience with Document Management Systems (e.g., D2) and/or Regulatory Information Management systems is preferred;
• Minimum of a bachelor's degree and 3 years of pharmaceutical industry experience;
• Experience in Regulatory Affairs or Regulatory Operations is strongly preferred. Other pharmaceutical experience (e.g., Research & Development, Quality Assurance/Compliance) will be considered;
• Proficiency in spoken and written English is required.

Vantagens

The company offers a competitive compensation and benefits package, as well as the opportunity to work in a collaborative, international, and cross-functional environment that values diversity, inclusion, and professional growth.