Business Systems Analyst – Regulatory Affairs

We are seeking a highly skilled Business Systems Analyst with 10+ years of experience in the pharmaceutical industry, specializing in Regulatory Publishing, Clinical Operations, and Safety Systems. The ideal candidate will have hands-on experience with Calyx RIMS, Veeva RIMS, and regulatory submission processes, including CTD reporting, GRANTS system tracking, and labeling workflows. This role requires a detail-oriented professional capable of collaborating across business and technology teams to drive system enhancements and maintain compliance with global health authority standards.

Key Responsibilities:

1. Regulatory and System Management:
   • Serve as the Business Admin for Calyx RIMS to track registrations and manage submissions to Health Authorities.
   • Oversee  system implementation, including requirement gathering and system enhancements.
   • Facilitate the CTD (Common Technical Document) reporting system by creating user stories, validating UAT results, and managing data integrity.
   • Ensure compliance with ICH, FDA, EMA, and other global regulatory standards through effective data tracking and reporting workflows.
2. Stakeholder Collaboration and Communication:
   • Conduct regular meetings with business units, IT teams, and external vendors to align on project deliverables.
   • Collaborate with Clinical Safety and Pharmacovigilance teams to implement tracking processes for safety submissions.
   • Communicate system updates and process changes to stakeholders and provide user training as needed.
3. Process Improvement and Documentation:
   • Analyze business processes to identify gaps and propose improvements in RIMS publishing workflows.
   • Document new processes, including submission planning, labeling applications, and safety tracking systems.
   • Maintain workflow diagrams and provide requirements documentation for system upgrades and integrations.
4. System Implementation and Support:
   • Support Veeva RIMS implementations, including internal releases and quarterly upgrades.
   • Create and manage system workflows to track labeling processes and Artwork requests.
   • Ensure the accurate transfer of data from PromoMats to Veeva RIMS, maintaining regulatory alignment.

Required Qualifications:

• 10 + years of experience as a Business Systems Analyst within the pharmaceutical or life sciences domain.
• Strong expertise in Calyx RIMS, Veeva RIMS, and GRANTS systems.
• In-depth knowledge of CTD reporting, regulatory Publishing processes, and global compliance (FDA, EMA, ICH).
• Experience working with cross-functional teams, including business, IT, and external regulatory bodies.
• Excellent documentation and process-mapping skills using industry-standard tools.
• Strong communication skills for stakeholder engagement and user training.

Preferred Skills:

Why Join Arka Innovate?

• Be a part of a dynamic team that values innovation and cutting-edge solutions.
• Work on diverse and impactful projects in various industries.
• Growth opportunities in a fast-paced and supportive environment.
• Hybrid Position – 3 days a week at client location.

At Arka Innovate, we are proud to be an Equal Opportunity Employer. We are committed to creating an inclusive environment for all employees and do not discriminate on the basis of race, color, religion, gender, sexual orientation, national origin, age, disability, veteran status, or any other legally protected status.