Job Description

Summary This role purpose is to act as a consultant and advisor providing guidance to improve complex global business processes, products, and services. We are looking for an experienced individual in Global Drug Development Regulatory Affairs to lead technical activities for the solutions that re-define how Novartis operates.
You will be working on strategic initiatives with the mandate to deliver solutions, which will bring transformative change to the business domain and will allow Novartis to realize a competitive advantage.

Position Title: Assoc. Dir. DDIT DEV RA Sol. Arch.
Location - Hyd-India #LI Hybrid
About the Role
This role purpose is to act as a consultant and advisor providing guidance to improve complex global business processes, products, and services. We are looking for an experienced individual in Global Drug Development Regulatory Affairs to lead technical activities for the solutions that re-define how Novartis operates.
You will be working on strategic initiatives with the mandate to deliver solutions, which will bring transformative changes to the business domain and will allow Novartis to realize a competitive advantage.
Your responsibilities include but are not limited to

• Create the detailed process designs necessary to operate the software/service on a day-to-day basis and Develop architectural solutions for Regulatory Affairs
• Utilize architecture patterns to suggest the most adequate utilization of technical platforms in support of the holistic solution architecture design.
• Ensure designs produced adhere to architectural roadmap and support the development, execution and operations of software/service
• Engage internal and vendor project teams to explain proposed Architecture and ensure technical governance of implementation and maintain and evolve Architecture tools and platforms, principles, policies and standards
• Ensure that detailed designs adhere to solution architecture design (i.e. high-level conceptual design) and are traceable to functional as well as non-functional requirements in functional specification
• Ensure the overall user experience is considered when designing new solutions and services. Take accountability to ensure adherence with security and compliance policies and procedures within Service Delivery scope
• Provide input to project proposals related to new technologies/innovations and drive Proof of Concept; evaluate new technological standards and its application on a day-to-day basis
• Work closely with program/ project manager and workstream lead. Work together with a product squad in delivering the Product's roadmap. Actively participate in sprint planning discussions and ensure sprint functional deliverables (prioritized backlog, user stories completed and demonstrated etc.) are on track
• Liaise with vendor, Novartis internal IT teams and business to ensure documentation is at the appropriate level of details and that the technical requirements are accurately interpreted and implemented and act as a technical expert between business and Implementation partners.

What you'll bring to the role:

• Multi-national global experience in 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)

Desirable Requirements:

• Bachelor's degree in engineering or pharmaceutical discipline. An advanced degree (MBA, MS etc.) and related accreditations (TOGAF, Veeva, Data Management certifications etc.) is a plus
• 12+ years of IT solution architecting experience with excellent communication skills and must have proven strong knowledge of SDLC, Validation & Compliance, Proficiency with tools such as Jira, Confluence, HPQC, modelling tools
• Experience in Data migration and System integration related projects and managing GxP Projects and related fields (desirable). Experience in digital and innovation related projects such as GenAI is a plus

Commitment to Diversity & Inclusion:
Novartis embraces diversity, equal opportunity, and inclusion. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates bold innovation through collaboration and empowers our people to unleash their full potential.
Skills Desired Business Architecture, Client Counseling, Enterprise Architecture, Influencing Skills, IT Governance, Performance Management, Solution Architecture

Skills Required