Apellis Pharmaceuticals · 1 day ago
Senior IT Business Systems Analyst - Regulatory
Waltham, MA
Full-time
Hybrid
Senior Level
$176K/yr - $264K/yr
5+ years expApellis Pharmaceuticals is a global biopharmaceutical company leading the way in complement science. The IT Business Systems Analyst acts as a strategic technology partner to implement process and system improvements focused on Regulatory systems, ensuring documentation of business requirements and providing oversight of system processes.
BiotechnologyHealth CarePharmaceuticalTherapeutics
Responsibilities
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)
Qualification
Required
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
Preferred
Experience with Veeva Vault (RIM Submissions, Submissions Archive, and Registrations)
Experience with IQVIA RIMSmart
Benefits
401(k) plan with company match
Inclusive family building benefits
Flexible time off
Summer and winter shutdowns
Paid family leave
Disability and life insurance
Company
Apellis Pharmaceuticals
Apellis Pharmaceuticals focuses on developing novel therapeutics and drug delivery technologies to address chronic inflammatory diseases.
501-1000 employees
H1B Sponsorship
Apellis Pharmaceuticals has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (11)
2024 (6)
2023 (6)
2022 (8)
2021 (7)
2020 (3)
Funding
Current Stage
Public CompanyTotal Funding
$919.6MKey Investors
Swedish Orphan BiovitrumSixth StreetNorthern Star Partners
2025-06-01Post Ipo Debt· $275M
2024-05-14Post Ipo Debt· $475M
2022-04-14Post Ipo Equity· $1.07M
Leadership Team
Cedric Francois
Co-founder, Chief Executive Officer , and President
Caroline Baumal
Chief Medical Officer
Recent News
News Powered by Cision
2025-12-05
Company data provided by crunchbase