Job Description Summary

The primary objective of this position is to serve as a consultant and advisor, offering expert guidance to enhance complex global business processes, products, and services in Regulatory Affairs. We seek a seasoned professional in GDD Regulatory Affairs who will lead both the strategic and operational implementation of Veeva Vault capabilities for Regulatory Registration Module. This role is responsible for ensuring alignment with organizational objectives, regulatory requirements, and enterprise architecture standards, whilst promoting product innovation and managing the lifecycle.
As Associate Director – Service Delivery, you will be responsible for leading and coordinating all phases of ongoing Veeva implementations. The role collaborates with stakeholders, manages vendor relationships, communicates project status, and ensures successful delivery through effective planning, monitoring, and issue resolution. This role has a key role in describing and translating business requirements in a way that they are clear, complete and easily understood by the business and other relevant stakeholders. The Business Analyst is actively involved in pre-project discussions, solution design discussions, to ensure the implementation fulfills the business requirements with a key focus on purpose, consistence and usability. Good technical background in conjunction with proven business analysis techniques and well-developed interpersonal skills are key success factor in this role.

Job Description

Position Title: Assoc. Dir. DDIT DEV RA BA

Location – Hyd-India #LI Hybrid

Your responsibilities include but are not limited to

• Develop project rationale and perform scoping assessments to determine feasibility of projects

  
  
  

• Highlight/identify gaps in existing functionality and review requirements with stakeholders

  
  
  

• Develop a comprehensive requirement specifications that will determine the estimate of cost, time and resources to deploy solutions

  
  
  

• Liaise with the service development team to suggest a high level functional solution

  
  
  

• Support in the development of project estimates and complete financial model (costs, savings, revenue opportunities, investment horizon, etc.)

  
  
  

• Ensure that relevant stakeholders are involved in specification of new services and/or major upgrades to existing services

  
  
  

• Ensure the overall user experience is taken into account when designing and deploying new solutions and services

  
  
  

• Ensure consistency and traceability between user requirements, functional specifications and testing & validation. Support validation and testing (OQ, PQ, UAT...)

  
  
  

• Ensure implemented solutions are according to specifications and fit for purpose.

  
  
  

• Support super user training

  
  
  

• Keep abreast with internal IT systems and documentation requirements, standards (including quality management and IT security)

  
  
  

• Keep abreast with industry best practices in leveraging technologies for the business and with regulatory environments / requirements if applicable. 

  
  
  

• Take accountability to ensure adherence with Security and Compliance policies and procedures within Service Delivery scope

  
  
  

• Work with Business and Process architecture teams to understand “as-is” and define “to-be” processes

  
  
  

Desirable Requirements:

• > 13 years’ experience in SDLC, system validation and Business Analyst role. >5 years in Drug Development domain

  
  
  

• Implementation experience of Veeva RIM module is a plus.  

  
  
  

• Regulatory domain knowledge (preferably Registration Information Management, IDMP, xEVMPD, IDMP|DADI|HL7|EUDAMED I FHIR etc.

  
  
  

• Proficiency with tools such as Jira, Confluence, Business process modelling tools

  
  
  

• Experience in Managing GxP Projects and Related Fields is a plus.

  
  
  

• Ability to manage medium size teams as part of project execution

  
  
  

• Good negotiation and facilitation skills. Ability to collaborate with a cross functional team on solution design

  
  
  

• Knowledge on business process modelling and canonical

  
  
  

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

Budget Management, Business Acumen, Influencing Skills, Performance Management, Risk Management, Service Delivery Management, Strategic Planning, Waterfall Model