Senior IT Business Systems Analyst - Regulatory

Senior IT Business Systems Analyst - Regulatory

The IT Business Systems Analyst acts as a strategic technology business partner to support and implement innovative process and system improvements to promote overall organizational efficiency and effectiveness, with a focus on Regulatory systems. This role ensures documentation of business requirements and business process definitions; systems consulting; and systems support management. This individual will provide oversight and continuity of the detailed system processes and configurations within and across software applications used at Apellis.

Location:

Hybrid Based Waltham, MA

• Collaborate with business stakeholders to understand, define, and document business processes and functional requirements
• Represent IT as a business analyst and technical SME, analyzing business needs, and identifying solutions that align to strategic goals
• Review, analyze, and evaluate business systems for their applicability to identified user needs
• Develop and maintain documentation for functional requirements and detailed business system processes
• Manage and coordinate support activities and incident resolution across internal teams and external personnel, including managed services vendor(s)
• Troubleshoot procedural, operational and configuration issues, and proactively document process improvements
• Ensure IT compliance by collaborating with Quality Validation and business stakeholders on computer system validation (CSV) and regulatory requirements (GxP)

• Thorough knowledge of Regulatory operations and related business functions, including Submissions, Publishing (Gateway,eCTD), and Labeling
• Customer Service oriented with a keen attention to detail and quality
• Ability to be empathetic to business user needs, and seeing things from their perspective
• Team-oriented and generous in sharing knowledge and enabling others
• Reliable, consistent, and proactive
• Capable of day-to-day problem solving and taking responsibility for decisions
• Must be able to effectively prioritize and plan. Ability to address multiple projects and adapt to changing priorities
• Strong verbal and written communication skills
• Ability to communicate and work with cross-functional/inter-departmental teams and within the framework of the IT organization, as well as to work independently
• Proficient in Microsoft Word, Excel, PowerPoint and other applications

• Experience with business process development and gap analysis, as well as business process mapping efforts
• Experience designing, deploying, and maintaining cloud-based applications
• Experience working in a GxP environment, including change control, change management, Computer Software Validation (CSV)
• Experienced in working with software vendors for support and maintenance
• Bachelor’s degree in computer science, technology, operations, or related disciplines required.
• 5+ years in a pharmaceutical/biotech or related environment required
• Highly desired:
  • Experience with Veeva Vault (RIM Submissions, Submissions Archive, and Registrations)
  • Experience with IQVIA RIMSmart

Base salary for this role will consider multiple factors, including but not limited to, candidate qualifications, relevant expertise, specialized skills, and industry experience in complement-targeted therapies. The targeted base salary range for this position is $176,000-$264,000. This range represents the base salary only and reflects Apellis' commitment to competitive compensation within the biopharmaceutical industry. The final salary offered may vary based on individual qualifications, business needs, and current market conditions.

Apellis offers a comprehensive benefits package, including a 401(k) plan with company match, inclusive family building benefits, flexible time off, summer and winter shutdowns, paid family leave, disability and life insurance, and more! Visit  to learn more.

Apellis Pharmaceuticals, Inc. is a global biopharmaceutical company leading the way in complement science to develop life-changing therapies for some of the most challenging diseases patients face. We ushered in the first new class of complement medicine in 15 years and now have two C3-targeting medicines approved to treat four serious diseases. Breakthroughs for patients include the first-ever therapy for geographic atrophy, a leading cause of blindness, and the first treatment for patients 12 and older with C3G or primary IC-MPGN, two severe, rare kidney diseases.

We believe we have only begun to unlock the potential of targeting C3 across many serious diseases.

Apellis is an equal opportunity employer and complies with all applicable federal, state and local fair employment practices laws. Apellis strictly prohibits and does not tolerate discrimination against employees, applicants or any other covered persons because of race, color, religion, creed, national origin or ancestry, ethnicity, sex (including pregnancy),…