Who are we?

- Infosys is a global leader in next-generation digital services and consulting with annual revenues of $16.31B (FY ‘22). We enable clients in 46 countries to navigate their digital transformation
- 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
- IC-LS is dedicated to serving Life Sciences firms globally.

What are we looking for?

We are looking for smart, self-driven, high energy people with top notch communication skills, intellectual curiosity and passion for ethics and compliance management as Risk & Compliance experts particularly in Life Sciences with the majority experience in consulting roles at a Tier 1 IT company or Big 4 / management consulting firm. Our consultants have a blend of in-depth domain expertise in one or more areas of Life sciences, strong business consulting skills and excellent soft skills.

What do we require?

Domain Specific skills:

- Subject Matter Expert in either one of the following - AI Risk Management / Monitoring / Assurance, Control Integration & Testing, SoX Compliance & Testing
- AI Risk Assurance
- Conduct comprehensive risk assessments of AI applications, including data integrity, model performance
- Ensure that AI systems comply with relevant regulations and standards, such as FDA guidelines, ISO standards, and GDPR, while keeping abreast of evolving regulations in the AI landscape
- Develop and implement risk assurance frameworks and methodologies specific to AI technologies in life sciences, ensuring alignment with organizational policies and industry best practices
- Collaborate with cross-functional teams, including data scientists, IT, compliance, and legal departments, to identify and mitigate AI-related risks throughout the product lifecycle
- Lead training sessions and workshops to enhance awareness of AI risk management among employees and stakeholders, fostering a culture of responsible AI use




- Establish metrics and monitoring systems to track AI risk factors and report findings to senior management and relevant regulatory bodies
- Solid understanding of AI technologies, machine learning algorithms, and their applications in Life Sciences space

Control integration & testing:

- Lead the design, development, and implementation of control integration systems for Life Sciences applications
- Collaborate with clients to understand their requirements and provide expert guidance on control systems architecture, configuration, and integration
- Ensure compliance with regulatory standards such as FDA, GxP, and ISO, and maintain documentation to support audits and inspections
- Conduct risk assessments and develop mitigation strategies for control integration projects

SOX Compliance & Testing:

- Lead the planning, execution, and reporting of SoX compliance activities for life sciences clients
- Develop and maintain SoX compliance frameworks, policies, and procedures in accordance with regulatory requirements
- Collaborate with cross-functional teams to identify and assess risks related to financial reporting and internal controls
- Design and implement testing strategies to evaluate the effectiveness of internal controls and compliance processes
- Conduct detailed testing of controls and document findings, recommendations, and remediation plans
- Monitor and track the progress of remediation efforts and ensure timely resolution of identified deficiencies
- Provide guidance and support to clients in understanding SoX requirements and best practices

General skills:

- Overall experience of 18+ years, with at least 2+ years of top-tier consulting experience post MBA in programs / projects with Lifesciences/ Healthcare clients
- Skilled regulatory background such as 21 CFR part 11, Data Privacy, Data Integrity, Information Security, GxP, and SOX IT knowledge
- Pre-Sales / Pseudo-Sales:



Minimum 5 years of active pre-sales / pseudo-sales experience: RFPs, client pitches, discovery workshops, and regulatory proposals — within the last 8-10 years of their career
- Proven ability in handling multiple large projects, respond quickly to changing situations in complex environments
- Experienced in leading strategic and tactical discussions with Senior Director and Director levels
- Is knowledgeable about market and regulatory trends that have the potential for substantive impact on organization strategies, policies, or risks.
- Ability to handle conversations with senior business and technology leaders from client teams
- Ability to build engaging client presentations (Expertise on MS PowerPoint, MS Word, MS Excel, MS Project)
- Appreciation for IT’s role in enabling business processes and growth
- Appreciation and understanding of Disruptive digital technologies

What will you do?

At IC-LS, you will:

- Be responsible for the delivery of business results to global pharmaceutical, medical devices and pharmaceutical distributors.
- Serve as a team member, track lead or engagement lead on business consulting engagements for clients.
- Execute or lead consulting engagements in a global delivery model, working with consultants across regions.
- Lead / contribute to sales pursuits, consulting offerings and internal initiatives.
- Analyze problems, and structure complex business analyses.
- Perform Business Process Improvement using various business consulting tools and methodologies.
- Work with cross functional client teams to perform gap analysis and identify improvement options.
- Create detailed action plans that include organizational change management, resource planning, competitive strategies, and alliances to embark on a new strategic direction and to enable successful deployment of solutions.
- Lead client workshops to collaborate with client employees and educate them throughout the process.
- Participate in a variety of Firm building events and the consultant referral program.
- Build deep industry experience with thought leadership

Where are we hiring?

- Pan-India across all major locations – Preference for following DC locations: Pune, Hyderabad, Bengaluru, Noida, Gurgaon, Kolkata.

📌 Regulatory Compliance Senior Principal (Maharashtra)
🏢 Infosys Consulting
📍 Maharashtra