Snr Specialist, IT Business Analyst, Technical Design (Regulatory Affairs)
Spain
Overview
This role acts as a consultant and advisor providing guidance to improve complex global business processes, products, and services in Global Drug Development Regulatory Affairs. The role leads business analysis activities for solutions that re-define how Novartis operates, supporting strategic initiatives with the mandate to deliver solutions that bring transformative change and a competitive advantage.
About the Role
Role Responsibilities
* Engage with global business associates and leverage the appropriate teams to determine requirements and deliver data-driven recommendations to improve efficiency and add value.
* Analyze the business domain and author business requirements. Coordinate and facilitate ongoing reviews of business processes.
* Ensure consistency and traceability between user requirements, functional specifications, and testing & validation. Support validation and testing as appropriate.
* Flag issues, changes, and risks to the Project Manager and workstream leads. Work with a product squad to deliver the Product’s roadmap. Actively participate in sprint planning and ensure sprint deliverables are on track.
* Liaise with vendors, Novartis internal IT teams, and business units to ensure documentation is detailed enough and that requirements are correctly interpreted and implemented.
* Act as interface between business and implementation partners. Review sprint demos and document any gaps.
Role Requirements
* Bachelor's degree in engineering or pharmaceutical discipline. An advanced degree (MBA, MS, etc.) and related accreditations (IIBA, Veeva, Agile certifications, etc.) are a plus.
* 7+ years of IT Business Analysis experience with excellent communication skills.
* Proven strong knowledge of SDLC, Validation & Compliance.
* Proficiency with tools such as Jira, Confluence, HPQC, and business process modelling tools.
* Experience in data migration and system integration related projects.
* Multinational global experience interacting with senior management, collaborating across boundaries and relationship management, and influencing without authority.
* Experience in Regulatory Affairs business processes is a plus (e.g., Registration Management, Submission Management, Submission Content management, Submission Publishing & Clinical Publishing, Product Labelling).
* Experience with Veeva Submission and Submission Archive module implementation is a plus.
* Experience in managing GxP projects and related fields is a plus.
Benefits & Rewards
Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: Novartis Life Handbook.
Benefits in Spain include Company Pension plan; Life and Accidental Insurance; Meals; Allowance or Canteen in the office; Flexible working hours.
Commitment to Diversity & Inclusion
We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.
Location & Relocation
This role is based in Barcelona, Spain. Novartis is unable to offer relocation support for this role; please apply only if this location is accessible for you.
Why Novartis
Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you—collaborating, supporting, and inspiring each other to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together?
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Snr Specialist, IT Business Analyst, Technical Design (Regulatory Affairs)
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