Subject Matter Expert

Job Description

Subject Matter Expert - Regulatory

About ArisGlobal ( www.arisglobal.com ):

The mission of ArisGlobal is to empower life science organizations to deliver breakthroughs faster, more accurately, and with greater precision. ArisGlobal s software, services, and technologies are essential to the delivery of life-saving medications. As an industry leader, ArisGlobal offers software as a service for Clinical Trials, Regulatory Affairs, Drug Safety, and Medical Affairs. Our products are utilized by 40 out of 50 major biopharmaceutical companies. Among our clients are four out of five of the worlds most advanced global pharmaceutical companies and nine government-health authorities, including the FDA, Health Canada, and the National Medical Products Administration.

ArisGlobal boasts a worldwide presence with offices located in the US, Croatia, Slovenia, Japan, China, and India. At ArisGlobal, we are distinguished by the high caliber of our team and by our passion for creativity and innovation. We pride ourselves on our welcoming and supportive corporate culture, which is inclusive of all Team Members.

Role : Subject Matter Expert

Experience : 13 to 16 Years

Job Location : Bangalore

Competencies:

• Exceptional communication skills both written and verbal to effectively transfer regulatory information to internal and external stakeholders.
• Strong analytical skills with the ability to analyze complex data sets, identify trends, and make informed recommendations for compliance improvements.
• Demonstrated ability to identify, analyze, understand and resolve regulatory requirements and incorporate them in service delivery projects efficiently.
• In-depth knowledge of regulatory requirements with proven ability to interpret and apply concepts in order to enhance ArisGlobal Solutions.
• Proficiently engaging in collaborative efforts with concurrent stakeholders across the organization.
• Exceptional proficiency in training and mentoring.
• Motivating team members to actively elevate daily practices through engaging discussions on proposed solutions, with the goal of identifying optimal outcomes.

Roles and Responsibilities:

• Initiates product enhancements and change requests to surpass customer expectation and contribute to the success of ArisGlobal Regulatory business.
• Provides functional leadership for new implementation, upgrade, configuration, and data migration projects.
• Provides guidance, information, and recommendations to both internal and external clients for solution configuration, ensuring clarity and managing expectations.
• Leads risk assessments related to regulatory compliance and service delivery to proactively address potential issues.
• Implements risk mitigation strategies in collaboration with relevant stakeholders.
• Collaborate with cross-functional teams to implement regulatory process enhancements.
• Demonstrates an understanding of system automation and offers design proposals for implementation.
• Delivers and assesses comprehensive information essential for developing SOW s and proposals.
• Contributes to major RFI/RFP responses, presales presentations and demos.
• Identifies new opportunities beyond the scope of ongoing projects, such as change requests, extensions or upsell opportunities.
• Collaborate with external stakeholders to ensure a positive relationship and alignment with organizational goals, coordinate and participate in customer audits.
• Actively contributes to presales activities.
• If necessary, performing other tasks and orders.