REGULATORY COMPLIANCE-Manager(Big4jobs)

Risk Management & Compliance

93+ Applicants

Posted: 1 week ago

8-12 years

Bengaluru

work from office

Posted: 1 week ago

Applicants: 93+

Job Description

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Job Description

As part of our EY-ER- Regulatory Compliance team, you will help the clients by understanding their business needs and delivering solutions in accordance with the EY guidelines methodologies.
As a Regulatory Compliance Manager actively establish, maintain and strengthen internal and external relationships.
In line with our commitment to quality, you'll consistently drive projects to completion with high quality deliverables, achieve operational efficiency, proactively identify and raise risks with the client as well as EY senior management team and lead internal initiatives.
We are seeking an experienced Manager, with strong consulting skills and deep industry expertise in Regulatory Affairs and Pharmacovigilance to lead IT implementation projects in regulated GxP environments.
This role expects the candidate to help the clients by understanding their business needs and translating their strategies into realities through innovation.

Role Overview

As a Manager Regulatory Compliance, you will lead IT implementation projects in regulated GxP environments, leveraging your deep expertise in Regulatory Affairs and Regulatory Information Management Systems (RIMS) and strong consulting capabilities.
Your primary responsibility will be to partner with clients to understand their business needs and translate strategic objectives into innovative, practical solutions. You will play a pivotal role in establishing and nurturing relationships across internal teams and external stakeholders, ensuring alignment with our commitment to quality and compliance.
This is a leadership role that demands strategic thinking, relationship-building, and a passion for delivering excellence in a highly regulated environment.

Your key responsibilities

Client

Lead regulatory strategy/ pharmacovigilance (Safety) strategy development for clients, ensuring compliance with global health authority requirements (FDA, EMA, MHRA, PMDA, etc).
Provide expert guidance on regulatory submissions, regulatory data lifecycle management, and dossier preparation across multiple markets.
Drive implementation and optimization of Regulatory Information Management Systems (RIMS) to streamline regulatory processes and ensure data integrity.
Deep understanding of PV regulations and guidelines, including ICH E2E, FDA, EMA, GVP Modules, and other international standards
Oversee end-to-end PV operations, including case intake, processing, case triaging, medical review, signal detection, risk management, and aggregate reporting
Collaborate with clients to design regulatory roadmaps, aligning processes, technology, and resources for efficient product registrations and maintenance.
Support clients in interactions with health authorities, including responding to queries and managing regulatory communications.
Identify opportunities for process automation and digital transformation within regulatory operations.
Participate in business development activities, including proposals, client presentations, and thought leadership in regulatory affairs and pharmacovigilance.
Ensure technology strategy alignment, including Regulatory systems and safety database systems and automation solutions.
Build strong internal relationships within Risk Consulting and across service lines to deliver integrated solutions.
Engage with client stakeholders, understand their challenges, and propose innovative digital solutions in the RA and PV space that enhance compliance and efficiency.
Stay current with evolving health authority regulations and industry trends, assessing implications for clients and advising proactive strategies.

People

Develop people through effective coaching and mentoring
Conduct performance reviews and contribute to performance feedback
Contribute to people-related initiatives including recruiting, retaining, appraisal and training
Contribute towards building and strengthening team competency for Regulatory Compliance and Risk consulting
Participate in the organization-wide people initiatives
Maintain an educational program to develop skills of team members continually

Decision-Making

Support management in workforce planning, resourcing strategy, go to market strategy and demand generation
Understand the business requirements clearly and lead practice development initiatives as required
Developing and implementing strategic plans to help clients navigate complex regulatory environments.
Overseeing project teams and ensuring that regulatory submissions and other deliverables are completed on time and within budget.
Building and maintaining relationships with key stakeholders, including regulatory agencies, clients, and industry groups.
Bring out of the box thinking mindset, and analytical thinking capability to enhance service delivery
Always maintain connections with clients to tap opportunities for constant growth and improvement
Lead business growth, pursuits and client proposals for Enterprise Risk/Regulatory Compliance, directly working with the regional partners Directors and Senior Managers.

Other

Oversee regulatory operations / global pharmacovigilance programs, ensuring compliance with regulatory requirements and delivery within timelines and budgets
Monitor global regulatory changes and assess their impact on client strategies and compliance obligations.
Provide expert guidance on PV process optimization, operational excellence, and technology adoption (including safety databases and automation tools).
Represent clients during audits, inspections, and meetings with regulatory authorities.
Lead RIMS implementation projects, ensuring seamless integration with other enterprise systems and compliance with data standards (eg, IDMP, xEVMPD).
Mentor and develop regulatory teams, fostering a culture of compliance, innovation, and continuous improvement.
Collaborate with cross-functional teams, including clinical, quality assurance, and supply chain, to ensure integrated regulatory strategies.
Drive adoption of advanced technologies such as AI/ML for regulatory intelligence and predictive analytics.

Skills and attributes for success

Looking to get Placed? Try our Placement Guarantee Plan

Extensive knowledge of global regulatory frameworks, including FDA, EMA, PMDA, ICH guidelines, GVP Modules, and regional requirements.
Strong expertise in Good Pharmacovigilance Practices (GVP), Good Clinical Practices (GCP), and related compliance frameworks and related tools (eg, Veeva Vault, Argus, ArisG, Lorenz).
Ability to design and implement regulatory strategies that align with business objectives and anticipate compliance challenges.
Excellent communication skills for conveying complex regulatory information to stakeholders.
Strong analytical and problem-solving skills for evaluating regulatory trends and operational risks.
Precision and attention to detail in preparing regulatory documentation and ensuring compliance.
Familiarity with electronic submission standards (eCTD, NeeS) and data standards (IDMP, xEVMPD).
Ability to work collaboratively with cross-functional teams across clinical, regulatory, and quality domains.
Commitment to high ethical standards and adherence to all applicable laws and regulations.

To qualify for the role, you must have

8 to 12 years of hands-on experience in regulatory area with around 3-5 years of experience in Veeva Vault RIMS and PV configuration and development
Proven experience in regulatory affairs, pharmacovigilance and RIMS implementation or management.
Strong interpersonal, written, and presentation skills.
Experience in managing regulatory teams and designing end-to-end regulatory solutions.
At managerial positions within Information Technology (IT) and/or Quality Assurance (QA) for major organizations
Experience in managing team and solution designing

Ideally, you'll also have

Certifications such as Regulatory Affairs Certification (RAC) or Certified Pharmacovigilance Professional, or Project Management Professional (PMP)
Experience with global regulatory submissions and lifecycle management, global PV audits and inspections.
Familiarity with emerging technologies in regulatory affairs, including AI/ML and automation tools.
Knowledge of IDMP compliance and structured data management for regulatory processes.
Experience in industry leading tools Veeva vault, Argus

A Team of people with commercial acumen, technical experience and enthusiasm to learn new things in this fast-moving environment with consulting skills.
An opportunity to be a part of market-leading, multi-disciplinary team of 1400 + professionals, in the only integrated global transaction business worldwide.
Opportunities to work with EY Consulting practices globally with leading businesses across a range of industries

Skills

Process OptimizationManager Quality AssuranceData ManagementGCPAnalyticalConsultingPharmacovigilanceRisk ManagementComplianceRegulatory ComplianceRegulatoryRegulatory AffairsRegulatory DocumentationRegulatory RequirementsRegulatory SubmissionsRisk ManagementCompliance ManagerRisk ConsultingEnterprise Risk

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About Company

EY India Careers 2025 – Overview

Ernst & Young Global Limited (EY) is one of the Big Four professional services organisations, headquartered in London, England, and operating in 150+ countries with a global workforce of ~400,000 professionals.

EY’s roots trace back to 1849 (Harding & Pullein) and 1903 (Ernst & Ernst), with the current global legal entity formed in 1989 through the merger of Ernst & Whinney and Arthur Young.

In India, EY employs ~50,000–55,000 people across offices in Gurugram, Mumbai, Bengaluru, Hyderabad, Chennai, Kolkata, and Pune. The firm operates through four integrated service lines — Assurance, Consulting, Strategy and Transactions, and Tax — helping clients capitalise on opportunities, manage risk, and deliver responsible growth.

EY’s purpose, Building a better working world, guides its work with businesses, governments, and non‑profits to solve complex challenges. The firm is recognised for its investments in AI (via the EY.ai platform), digital transformation, sustainability, and inclusive growth.

Business Model

EY operates as a service‑based B2B professional services firm, generating revenue through assurance, consulting, strategy & transactions, and tax services.

Its model blends:

Deep sector expertise with technology‑driven solutions
Global delivery capabilities with India as a strategic hub
Long‑term client relationships built on trust and recurring engagements

Strategic priorities for EY India include:

Scaling EY.ai and AI‑enabled services
Expanding ESG and sustainability consulting
Strengthening cybersecurity and digital transformation offerings
Growing Strategy and Transactions advisory in high‑growth sectors

Recent Wins & Recognition

Launched the EY.ai platform to integrate AI into all service lines globally and in India (https://www.ey.com/en_in/news/2023/ey-launches-ey-ai-platform).
Advised on a $1.1 billion renewable energy acquisition in India (https://economictimes.indiatimes.com/industry/energy/power/ey-advises-on-renewable-energy-acquisition/articleshow/).
Recognised as a Leader in Digital Strategy Consulting in the 2025 IDC MarketScape report (https://www.ey.com/en_in/news/2025/ey-named-leader-in-digital-strategy-consulting).
Partnered with the Government of India on Gati Shakti infrastructure planning (https://www.ey.com/en_in/news/2024/ey-supports-gati-shakti-infrastructure-planning).
Awarded Best Employer for Women 2025 by Working Mother & Avtar (https://www.ey.com/en_in/news/2025/ey-best-employer-for-women).

Culture & Values

EY’s culture is anchored in its EY Values:

People who demonstrate integrity, respect, and teaming
People with energy, enthusiasm, and the courage to lead
People who build relationships based on doing the right thing

The firm promotes diversity, equity, and inclusion, offers global mobility opportunities, and invests heavily in continuous learning through EY Badges, EY Tech MBA, and leadership programs.

Client‑Facing Businesses

Assurance

What it is – Independent audit and assurance services to enhance trust in financial reporting. Careers in India include:

Statutory Audit – Auditing financial statements for listed and unlisted companies.
Financial Accounting Advisory Services (FAAS) – IFRS/Ind AS advisory, reporting, and accounting change support.
Forensic & Integrity Services – Fraud investigation, dispute resolution, and compliance reviews.
Climate Change & Sustainability Services (CCaSS) – ESG reporting and assurance.

Consulting

What it is – Advises clients on business transformation, technology, and risk. In India, career opportunities span:

Business Consulting – Strategy, operations, and supply chain transformation.
Technology Consulting – ERP, cloud, data analytics, and cybersecurity.
Risk Consulting – Enterprise risk, internal audit, and regulatory compliance.
People Advisory Services – Workforce strategy, change management, and HR transformation.

Strategy and Transactions (SaT)

What it is – End‑to‑end deal advisory and capital strategy. India‑based roles cover:

M&A Advisory – Buy‑side and sell‑side deal advisory.
Transaction Diligence – Financial, tax, and operational due diligence.
Valuation, Modelling & Economics – Business valuations and financial modelling.
Restructuring – Turnaround and insolvency support.

Tax

What it is – Comprehensive tax and regulatory services. In India, career paths include:

Direct Tax – Corporate and international tax compliance and planning.
Indirect Tax – GST, customs, and trade advisory.
Transfer Pricing – Planning, documentation, and dispute resolution.
Tax Technology & Transformation – Automation and analytics for tax functions.

Important dates & deadlines?

Application Deadline

30 Mar 26, 03:53 PM IST

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