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Associate RA Director

2 months ago

Bengaluru, India IQVIA India Full time

Job Title / Primary Skill: Associate RA Director

Management Level: G160

Years of Experience: 15+ Years

Job Location: Bangalore


Key Responsibilities & Technical Experience


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.