Regulatory Compliance Senior Principal

Infosys Consulting; Pune District; On-site; INR 4,000,000 - 7,000,000; Full time

Job summary

Infosys Consulting is seeking risk & compliance experts in Life Sciences with strong consulting experience. The role emphasizes domain expertise in AI risk management, control integration, and SoX compliance across pharma, medical devices, and distributors.

You will collaborate with data scientists, IT, and legal teams to ensure regulatory alignment and effective risk mitigation. Successful candidates bring 18+ years of experience, including 2+ years in top-tier consulting post MBA, and strong

Qualifications

• Subject Matter Expert in AI risk management, monitoring, assurance, control integration testing, or SoX testing.
• Ability to conduct comprehensive risk assessments of AI applications including data integrity and model performance.
• Ensures AI systems comply with FDA, ISO, GDPR and evolving AI regulations.
• Develops risk assurance frameworks aligned with policies and best practices in life sciences.
• Collaborates with data scientists, IT, compliance and legal to mitigate AI risks across the lifecycle.

Responsibilities

• Deliver business results for global pharmaceutical, medical devices and distributors.
• Serve as team member or engagement lead on consulting engagements.
• Lead or contribute to sales pursuits and internal initiatives.
• Perform business process improvements using consulting tools and methodologies.
• Lead client workshops and educate stakeholders throughout the process.
• Create action plans covering organizational change, resources, and strategy deployment.

Skills

AI Risk Management

Control Integration

SOX Compliance

Regulatory Awareness

Education

MBA

Tools

MS PowerPoint

MS Word

MS Excel

MS Project

Job description

• 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
• 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
• Strong 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
• 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.