At EY, you’ll have the chance to build a career as unique as you are, with the global scale, support, inclusive culture and technology to become the best version of you. And we’re counting on your unique voice and perspective to help EY become even better, too. Join us and build an exceptional experience for yourself, and a better working world for all.

EY- GDS Consulting – Enterprise Risk - ER – Regulatory Compliance – Senior Manager

As part of our EY-ER- Regulatory Compliance team, you will help the clients by understanding their business needs and translating their strategies into realities through innovation. As a Regulatory Compliance Senior 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, identify automation opportunities and drive internal initiatives.

The opportunity

We’re looking for Senior Manager with expertise in Life Sciences Regulatory Affairs and Stakeholder Management to join the leadership group of our EY-Regulatory Compliance team. This is a fantastic opportunity to be part of a leading firm whilst being instrumental in the growth of emerging service offering.

Your key responsibilities

Client Responsibilities

• Deliver regulatory strategies for clients and drive timelines aligned with business needs.
• Sound knowledge of regulations CFR Part 210, 211, CFR 820, ISO 13485; IEC 62304; IEC 62366; ISO 14971.
• Knowledge of regulatory evaluation of drugs, devices and their respective submission cycle.
• Drive-in business development activities, such as identifying new clients, expanding services, and contributing to the growth of the consultancy.
• Work closely to ensure right level of processes, training and personnel are placed to support all Regulatory deliverables from Product Development, Go to Market, Product Certifications Post Market Regulatory expectations.
• To work with clients and support communications for internal and external regulatory bodies to obtain and maintain regulatory compliance.
• Provide leadership and direction for the reporting functions supporting regulatory activities.
• Liaison with all external regulatory certifying bodies to enable certifications and its audits
• Knowledge of periodic reporting of health of the Regulatory Status of Products at site to the top management
• To ensure pre-market and Post Market regulatory expectations for products are met
• Ensure the manufacturing facility Product Development teams follows GDP, GMP, technically sound, safe and environmentally acceptable manner by complying with Quality Policy ISO 9001,13485 requirements and other relevant regulations and best practices.
• Build strong internal relationships within Risk Consulting practice and with other services across the organization.
• Build connect with client stakeholders, understand their business challenges/pain areas and work with leadership to propose innovative solutions.
• Stay informed about changes in regulatory legislation and guidelines, both domestically and internationally, and understanding the implications for clients.

People Responsibilities

• 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 Responsibilities:

• 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 and Associate Directors.

Other Responsibilities

• Lead and manage regulatory projects for clients, ensuring deliverables are met within timelines and budgets.
• Provide expert advice on regulatory pathways, submission strategies, and compliance issues.
• Develop and maintain relationships with regulatory agencies and key stakeholders.
• Oversee the preparation and submission of regulatory documents, including Investigational New Drug (IND) applications, New Drug Applications (NDAs), Biologics License Applications (BLAs), and marketing authorization applications in various regions.
• Monitor changes in regulatory legislation and guidelines, and assess the potential impact on clients' business.
• Represent clients in meetings with regulatory authorities.
• Mentor and develop team members, fostering a culture of continuous improvement and professional growth.
• Collaborate with cross-functional teams, including clinical, quality assurance, and business development, to ensure integrated and aligned regulatory strategies.
• Participate in business development activities, including proposal writing and client presentations.

Skills and attributes for success

• Extensive knowledge of regulatory guidelines and legislation, including FDA, EMA, and other international regulatory agencies.
• Understanding of Good Manufacturing Practices (GMP), Good Clinical Practices (GCP), and Good Laboratory Practices (GLP) is essential.
• Ability to develop regulatory strategies that align with business objectives and to anticipate regulatory obstacles and emerging issues throughout the product lifecycle.
• Managed regulatory submissions, including Investigational New Drug (IND) applications, New Drug Applications (NDA), Biologics License Applications (BLA), and Marketing Authorization Applications (MAA).
• Ability to effectively communicate regulatory information and strategies to stakeholders.
• Strong analytical and problem-solving skills to evaluate scientific data and regulatory trends.
• Ability to work collaboratively with cross-functional teams including research and development, clinical, quality assurance, and marketing.
• Precision and attention to detail in preparing regulatory documentation and ensuring compliance with regulations.
• Proficiency with regulatory information systems and electronic submission software.
• Ability to identify and assess regulatory risks associated with product development and to develop risk mitigation strategies.
• Upholds high ethical standards and ensure that regulatory strategies and practices comply with all applicable laws and regulations.

To qualify for the role, you must have

• A bachelor's degree in life sciences, pharmacy, medicine, law, engineering, or a related field is often required. An advanced degree such as a Master's or Ph.D. can be beneficial.

Good interpersonal skills;

• Good written and presentational skills
• 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

• Certified Clinical Research Professional (CCRP), Regulatory Affairs Certification (RAC)
• Certified Quality Auditor (CQA)
• Certified Regulatory Compliance Manager (CRCM)
• Project Management

What we look for

• 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

What working at EY offers

At EY, we’re dedicated to helping our clients, from start–ups to Fortune 500 companies — and the work we do with them is as varied as they are.
You get to work with inspiring and meaningful projects. Our focus is education and coaching alongside practical experience to ensure your personal development. We value our employees and you will be able to control your own development with an individual progression plan. You will quickly grow into a responsible role with challenging and stimulating assignments. Moreover, you will be part of an interdisciplinary environment that emphasizes high quality and knowledge exchange. Plus, we offer:

• Support, coaching and feedback from some of the most engaging colleagues around
• Opportunities to develop new skills and progress your career
• The freedom and flexibility to handle your role in a way that’s right for you

EY | Building a better working world

EY exists to build a better working world, helping to create long-term value for clients, people and society and build trust in the capital markets.

Enabled by data and technology, diverse EY teams in over 150 countries provide trust through assurance and help clients grow, transform and operate.

Working across assurance, consulting, law, strategy, tax and transactions, EY teams ask better questions to find new answers for the complex issues facing our world today.