C2C requirements Regulatory Affairs IT Specialist – Veeva Vault RIM Marlborough , MA

Regulatory Affairs IT Specialist – Veeva Vault RIM

Location: ~Marlborough~ , MA

Duration: 6 months

“Regulatory Information Management:

•   Manage the lifecycle of regulatory submissions, including the preparation, tracking, and filing of documents in Veeva Vault RIM.

•   Ensure that regulatory submissions comply with applicable local and international regulations and guidelines.

•  Maintain and update regulatory documentation, including registration dossiers, variation applications, and compliance documents.

System Configuration and Maintenance:

•  Configure and customize Veeva Vault RIM to meet organizational needs, ensuring it aligns with regulatory requirements and workflows.

•   Monitor system performance, troubleshoot issues, and coordinate with Veeva support for resolution.

Data Management:

•     Ensure the integrity and accuracy of regulatory data within Veeva Vault, including product information, submission statuses, and regulatory milestones.

•    Implement data governance practices to maintain compliance and quality of regulatory data.

Cross-Functional Collaboration:

•    Collaborate with various teams, including Regulatory Affairs, Quality Assurance, Clinical Development, and Pharmacovigilance, to ensure timely and accurate regulatory submissions.

•   Act as a point of contact for regulatory queries and provide training to internal teams on Veeva RIM functionalities.

Process Improvement:

•     Identify opportunities for process enhancements and automation within the regulatory submission process.

•     Develop and implement standard operating procedures (SOPs) for the use of Veeva Vault RIM.

Regulatory Compliance:

Stay updated on regulatory changes and ensure that the organization’s processes and systems comply with current regulations and industry best practices.

Participate in audits and inspections as necessary, providing documentation and system access as required.

Qualification:

At least 8-9 years of professional experience IT industry Regulatory Affairs Experience in Regulatory information management VEEVA RIM Demonstrated practical working experience in both processes (eg.xEVMPD) and untilisation of regulatory systems (RIMS, VEEVA)

•          Good understanding of Regulatory Affairs business processes Regulatory Information management VEEVA Vault RIM experience

•          Good understanding of both processes (eg.xEVMPD) and systems (eg.RIMS, VEEVA) Results-driven and pragmatic approach to work Good organizational skills, self-motivated and proactive Meticulous working style and high attitude to quality

•          Veeva Vault admin certification is required

•          Experience with Veeva RIM Connectors is preferred

•          Good Presentation skills for conducting product demonstrations.

•          Excellent analytical and problem-solving skills, with attention to detail and accuracy.

•          Good stakeholder management and communication skills Strong service mentality Quick comprehension, good analytical and problem solving skills

·         Ability to work in a virtual and matrix environment”

Thanks & Best Regards

Bhargavi Jaltar| Talent Acquisition Lead| Tekgence Inc.

Office : bhargavi@tekgence.com