Associate RA Director
Location: Bengaluru, India
Job Description
– Support IDMP/SPOR data readiness for EU/EEA Client portfolio via necessary updates in xEVMPD or PMS UI to secure PLM eAF variations and EU requirements (e.g. for ESMP=European Shortages Monitoring Platform).
– Support data verification of product data migrated to Master Data Management in alignment with current RIMS and DMS Systems and their maintenance.
– Contribute to the technical assessment of upcoming IDMP requirements/guidance documents in EU & non EU regions and propose current systems or process changes as relevant.
– Contribute to communication platforms and training initiatives to raise awareness on IDMP requirements and Data Governance principles within and outside RA (e.g., Newsletters, role-based trainings).
– Propose set-up of an internal solution and process to maintain User Access Management for all EMA systems centrally.
– Act as CoE Lead for Regulatory Data and Document Management System (RDDMS) Center of Excellence and be responsible for overseeing the RIM and document co-ordination support.
– This individual is responsible for the development and implementation of policies and procedures for RIM data management compliance with regulatory requirements and industry best practices.
– Contribute to digital projects with assigned SMEs and Technology Transformation partners to ensure the best fit to the Regulatory Affairs priorities and digital program strategy.
– Contribute to cross-functional task forces of multidisciplinary experts ensuring the execution of digital projects and implementation of data governance.
– Have understanding of Global Regulatory submission activities (planning, authoring, reviewing, coordination, submission) for assigned projects/products.
– Identify the required documentation and any content, quality and/or timelines issues for global submissions and negotiate the delivery of approved technical source documents in accordance with project timelines.
– Providing strategic guidance and direction to the RIM team, ensuring that they are up-to-date on regulatory changes and trends.
– Collaborating with cross-functional teams to ensure that RIM is incorporated into business decision-making processes.
– Monitoring and analyzing regulatory intelligence data to identify trends and manage data compliance.
– Identifying opportunities for process improvement and implementing best practices to increase efficiency and effectiveness.
– Building and maintaining relationships with external stakeholders, including regulatory agencies, industry associations, and key opinion leaders.
– Participate in RFI/RFP and Bid defense to drive and explore the RDDMS business.
– Build GoTo market strategy and material to increase visibility of IQVIA RDDMS in industry.
– Have proficient experience in Line management, mentoring, coaching to aligning the team to company’s common goal.
– Support cross functional activity across the regulatory operation management.
– Support and act as technology domain lead for RIM activities.
– Must have extensive Project Management experience with a view to lead project excellence.
Qualifications for this role may include:
– Masters/Bachelor’s degree in a relevant field, such as regulatory affairs, pharmacology, or life sciences.
– 15+ years of experience in regulatory affairs or related field, with a strong background in RIM Data management, IDMP and xEVMPD.
– Experience leading a team of RIM professional, technology experience and act as line manager.
– Strong knowledge of regulatory requirements and industry best practices related to regulatory RIM data management.
– Excellent communication and leadership skills, with the ability to collaborate effectively with cross-functional teams.
– Strong analytical and problem-solving skills, with the ability to identify trends and provide insights to leadership.
– Ability to manage multiple projects simultaneously and prioritize competing demands.