Location: Barcelona, Spain (On-site) 3 days working from the office and 2 days working from home

Enterprise Regulatory Vault (ERV) is AstraZeneca's business-wide system for Regulatory Information Management (RIM). As a data-centric cloud / SaaS platform it enables compliance with current regulatory requirements and can evolve to meet future needs. This flexibility brings many benefits, but also the key challenge of a relentless cycle of incremental and continual changes that requires ongoing investment of time and resources to ensure AZ maximizes utility and enables automation, digitization and agility to meet future needs.
Global Regulatory Operations (GRO) is accountable for ownership of ERV, ensuring it is effectively developed, maintained, governed and supported across the enterprise to meet scientific, business and compliance needs.
The ERV Product Manager works in close collaboration with the ERV Strategic Director to execute the strategic direction for ERV, implementing agreed strategy and ensuring continuous improvement of the Enterprise Regulatory Vault Platform from the business perspective within the IT platform model. The incumbent oversees all key elements of the RIM platform (e.g. Registration, Submissions/Submissions Archive, Data Analytics/Dashboards, Regulatory Insight, Automation/Publishing, Integrations), and coordinates activity of ERV Product Owners across the entire landscape of Regulatory applications.

This role provides leadership, executes and ensures alignment in the following areas:

• Coordinate activity of all ERV elements to shape the Regulatory Platform
• Supports and challenges ERV product owners, prioritizing and triaging activity across all ERV elements
• Expert in all ERV elements, providing support and guidance to product owners and IT colleagues
• Influencing Veeva in future product development to ensure prioritization of AZ needs and tracking delivery
• Partnering with other Veeva customers to influence the Veeva roadmap
• Participates in external forums to anticipate industry trends and future regulatory compliance needs
• Planning future investment to ensure ongoing viability of ERV and effective use of RIM data

Typical Accountabilities

Shaping the platform:

• Understand business needs for use of ERV and develop requirements and user stories to meet those needs
• Identify opportunities for improvement and evaluate and prioritize enhancement needs.
• Effective management of risks and opportunities
• Establish and drive business cases to implement new functionality
• Lead the planning, management and resourcing of annual reporting and system release cycles.
• Act as a change agent during the global roll-out of new technologies, embedding new tools and technologies into the business

Ensuring ERV meets business need:

• Collaborate with key business stakeholders to develop metrics to evaluate system performance
• Understand industry best practice to drive ERV development, standardization and implementation to achieve or maintain world class RIM status
• Represent ERV during audits and regulatory authority inspections
• Represent ERV and provide expert input to global system and data initiatives to drive consistency and standardization.
• Influence stakeholder groups to instill cultures and behaviors required for a data-centric, data-quality and master source mentality.

Partnering and Collaborating:

• Build strong relationships with customer groups, developing deep understanding of the current business as well as future direction; responding to changing needs and assessing and prioritizing in line with AZ and GRO strategy and expectations
• Function as subject matter expert, providing advice and analysis to AZ product teams and co-development partners on matters pertaining to RIM and cross-RIM applications and initiatives.
• Work closely with other experts in AZ who are involved in the design, development and delivery of RIM system capabilities and related business deliverables such as policies, procedures, processes and guidance
• Stimulate conceptual thinking and creativity and challenging the status quo for continuous improvement

• Advocate and influence vendors for continuous improvement practices to ensure that RIM supports the AZ product portfolio and anticipates future business needs and industry requirements.
• Provide expertise within area of accountability to support mergers, acquisitions, divestments, offering RIM Expert advice on best practices to further support AZ strategic ambition
• Representing AZ externally in areas relevant to RIM and best practice – e.g. vendor forums, industry forums, collaborators, technical service partners
• Provide coaching & mentoring for colleagues to assist with their personal development

Education, Qualifications, Skills and Experience

Essential

• Master's degree or higher in a scientific, business or information sciences discipline, and/or relevant experience in the bio-pharmaceutical industry
• 10+ years' experience and proven technical competence in developing and deploying RIM solutions in support of regulatory information management
• Excellent knowledge of procedures and compliance standards governing drug development and regulatory submissions
• A broad understanding of regulatory and drug development activities and the challenges associated with critical business and compliance activities.
• Experience working in the Regulatory Information management domain
• Experience implementing new (or changes to) IT systems, with a particular focus on understanding and meeting the Business requirements
• Demonstrated leadership skills interacting with senior leaders
• Able to identify opportunities and to instigate and lead change through innovation – seeking continuous improvement based on strong awareness of external practice.
• Strong influencing, negotiation and communication skills
• Fluent in written and spoken English

Desirable

• Experience working in a large virtual and global project team
• Understanding of the drug development process, and the different sources of information that will support, inform and assist in Trial Design and execution

Date Posted

Closing Date

AstraZeneca embraces diversity and equality of opportunity.  We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills.  We believe that the more inclusive we are, the better our work will be.  We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics.  We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.