RC-REGULATORY COMPLIANCE-REGULATORY...

Job Opportunity: Regulatory Compliance Manager at EY, Kolkata

EY is seeking a skilled Regulatory Compliance Manager to join our Enterprise Risk (ER) – Regulatory Compliance team in Kolkata, West Bengal, India. This is an exceptional opportunity to advance your career within a globally recognized firm, contributing to the growth of an emerging service offering. At EY, you will leverage your unique skills and perspective to help clients achieve their business objectives by delivering innovative solutions aligned with EY's methodologies. You will be instrumental in establishing, maintaining, and strengthening client relationships, ensuring high-quality deliverables, operational efficiency, and proactive risk management.

About the Role:

As a Regulatory Compliance Manager, you will guide clients through complex regulatory landscapes, focusing on Computer System Validation and Stakeholder Management. You will work within the leadership group of our EY-Regulatory Compliance team, playing a pivotal role in shaping our service delivery.

Key Responsibilities:

• Contribute to IT application project management, including validation activities using the GAMP Life Cycle approach.
• Integrate technology with business process transformations across systems such as SAP, LIMS, ELN, MES, Documentum, TrackWise, Veeva Vault, ValGenesis, Argus, and Regulatory Information Management Systems.
• Perform gap assessments and remediation for legacy applications to ensure compliance with validation policies and life cycle approaches.
• Conduct software classification, IT risk assessments, and develop mitigation strategies for IT applications.
• Provide expert guidance and knowledge sharing, particularly on complex or specialized regulatory issues.
• Develop engagement strategies and plans that adhere to professional standards and address inherent risks.
• Support business development initiatives by nurturing client relationships and ensuring efficient execution of deliverables.
• Identify cross-selling opportunities for other EY services within existing client accounts.
• Oversee project planning and monitor the delivery of team-related tasks.
• Generate innovative client insights, adapt methods to team needs, and contribute to thought leadership.
• Foster teamwork by collaborating with cross-functional teams across service lines to meet deadlines.
• Maintain a strong client focus by effectively serving client needs and building productive relationships. Stay informed about business and economic trends relevant to clients.
• Provide regular status reporting to senior management and onsite coordinators.
• Drive improvements in operational efficiency for projects and internal initiatives.
• Demonstrate a deep understanding of market trends, competitor activities, and EY's service offerings.
• Be flexible to travel to client locations as needed.
• Conduct performance reviews and provide constructive feedback to team members.
• Promote teamwork, a culture of quality, and lead by example.
• Adhere to workplace policies and procedures.
• Train and mentor project resources.
• Participate in organization-wide and practice-level initiatives.
• Stay abreast of market and digital trends.
• Cross-skill and cross-train team members to meet business requirements.

Skills and Attributes for Success:

• Proven experience in Quality & Compliance managed services and Consulting within the Life Sciences Domain.
• Sound domain knowledge in the Pharmaceutical industry, particularly in Quality and Compliance.
• Strong understanding of Computerized Systems Validation concepts, including GAMP 5.
• Experience in executing Validation Deliverables in software implementation projects.
• In-depth knowledge of standards such as USFDA 21 CFR Part 11, EU GMP Annex 11.
• Familiarity with regulations including USFDA, WHO, HIPAA, TGA, MCC, Anvisa.
• Proficiency with ICH guidelines, ISPE framework on Risk Management, and System Development Life Cycle concepts.
• Extensive knowledge of Enterprise IT applications like LIMS, SAP, ELN, MES, Documentum, TrackWise, Veeva Vault, ValGenesis, Argus, and Regulatory Information Management Systems in pharmaceutical organizations.
• Experience with SOP documentation, work instructions, and user manuals.
• Strong knowledge of Quality System Elements (Deviation, CAPA, Change Controls) as they relate to Computer Systems.
• Solid understanding of Data Integrity requirements.

Governance and Reporting:

• Knowledge of Incident Management, Change Management, Periodic Review, Vendor Management, and Quality Management Review procedures.
• Strong expertise in authoring and reviewing Validation Deliverables such as Validation Plans & Reports, Requirement Specifications, Risk Analyses, Qualification Protocols & Reports, Test Scripts, and Traceability Matrices.
• Experience supporting audits and inspections.

Qualifications:

• B.E/B.Tech (Electronics, Electronics & Telecommunications, Computer Science) or Postgraduate in Science (preferably Chemistry/Biochemistry).
• 10-12 years of experience with Big 4 or Multi-National Regulatory Compliance companies.
• Excellent interpersonal, written, and presentation skills.
• Experience in managerial positions within Information Technology (IT) and/or Quality Assurance (QA) for major organizations.
• Proven experience in team management and solution designing.

Ideal Candidate Profile:

• Certified Software Quality Engineer (CSQE) or Certified Software Quality Assurance (CSQA).
• ISO 9001:2015 Lead Auditor or Quality Auditor Certification (CQA).
• Information Security or Risk Management certifications.
• Project Management certifications.

EY offers a dynamic work environment with opportunities to work on meaningful projects, gain practical experience, and develop your career through individual progression plans. You will be part of an interdisciplinary team that values high quality and knowledge exchange. We provide support, coaching, feedback, and the flexibility to manage your role effectively.