Who are we?
- Infosys is a global leader in next-generation digital services and consulting with annual revenues of $16.31B (FY ‘22).
Infosys Consulting
partners with clients from strategy through execution to transform their businesses in areas such as business/ IT strategy, processes, organization, systems and risk. Infosys Consulting has 2,500+ people across the US, Europe, APAC and India- We are
Value Integrators
– we deliver realized business value by managing transformations from strategy / setting direction through execution, including operating and optimizing delivered solutions
What are we looking for?
in-depth domain expertise
What will you do?
- Responsible for requirements management plans including elicitation, approvals, processes, RAID, and scope impacts.
- Highly responsive to changing business priorities with the ability to plan, accounting for potential changes and corrective actions.
- Advanced requirements elicitation and management skill set; including traceability, testing and validation.
- Leads the work with the business Product Owner & Managers to identify functional and technical requirements, translating the requirements into technical design specifications reflecting Functional Design, User Interface Design and Business Process Design.
- Closely partners with the Architecture team, ensuring the technical solution will meet the business requirements·
- Execute consulting engagements in a global delivery model, working with consultants across regions- being part of a team of high performing consultants
- Contributing to the profile and reputation of Infosys Consulting through firm building, new capability and offering development initiatives, thought leadership, whitepapers
What do we require?
- We are seeking experienced regulatory professionals with 3 – 10 years of experience and a strong Life Sciences background to join our team.
- The ideal candidate will work at the intersection of business and client needs, leveraging expertise in IDMP, RIMS/MDM, CMC, Publishing Operations, Regulatory Intelligence, and Regulatory Automation to identify challenges and deliver innovative solutions.
- This role involves cross-functional collaboration, process improvement, and strategic analysis to support business transformation initiatives. You will work alongside analysts and developers to design and implement effective solutions.
Key Responsibilities:
- Lead and support regulatory operations and data management using Veeva Vault and other platforms.
- Document business requirements, functional designs, and business scenarios.
- Conduct market and process analysis to identify gaps and improvement opportunities.
- Drive automation and digital transformation initiatives within regulatory functions.
- Collaborate with stakeholders to ensure alignment with regulatory and business goals.
Key Qualifications:
- Bachelor’s or Master’s degree in Life Sciences, Pharmacy, Biotechnology, or related field.
- 3 - 10 years of experience in Regulatory Affairs or Compliance.
- Minimum 3+ years of experience in documenting business requirements and functional designs.
- Hands-on experience with Veeva Vault RIM, ArisGlobal RIMS, Documentum, Liquent Insight.
- Strong analytical thinking and problem-solving skills focused on enhancing user experience.
- Proven ability to manage stakeholders, resolve conflicts, and influence outcomes.
- Familiarity with Agile methodology is a plus.
- Experience with tools like Jira and Confluence is an advantage.
Location of Posting:
Bengaluru, Hyderabad, Chennai, Kolkata, Bhubaneswar, Noida, Gurgaon, Chandigarh, Pune, Navi Mumbai, Indore, Trivandrum, Mysuru
