Logo of Huzzle

Home

Matches

Explore

Manage

Vice President, Global Regulatory Affairs Consulting Services

image

ICON plc

Sep 18, 2024

  • Job
    Full-time
    Expert Level
  • Business, Operations & Strategy
  • Dublin
  • Quick Apply

AI generated summary

  • You need a Bachelor's in Life Sciences or business, 10+ years in global regulatory affairs, leadership experience, financial acumen, strategic thinking, strong regulatory knowledge, and excellent communication skills.
  • You will oversee global regulatory consulting services, drive strategic growth, manage budgets, ensure compliance, build client relationships, and lead team performance while delivering projects efficiently.

Requirements

  • Education: A Bachelor's degree in Life Sciences, Business Administration, or a related field is required; a Master's degree or MBA is preferred.
  • Experience: 10+ years of experience in global regulatory affairs within a CRO environment and industry position (preferred).
  • Leadership Skills: Proven leadership experience in managing large, global cross-functional teams, including the ability to drive performance, accountability, and engagement across multiple functions.
  • Financial Acumen: Proven ability to manage budgets, control costs, and ensure financial targets are met. Direct P&L responsibility preferred. Experience in financial reporting and analysis to support business objectives.
  • Strategic Thinking: Strong strategic and analytical skills, with the ability to develop and execute business strategies that align with organizational goals and drive growth.
  • Regulatory Knowledge: Strong knowledge of global regulatory requirements and processes, including submissions for MAAs, NDAs, CTAs, INDs, and post-licensing activities.
  • Communication Skills: Exceptional communication, negotiation, and interpersonal skills, with the ability to interact effectively with clients, senior management, and cross-functional teams.
  • Adaptability: Ability to thrive in a dynamic and fast-paced environment, managing multiple priorities and driving continuous improvement in processes, systems, and client delivery.
  • Located – Ireland or UK
  • Travel - Able to travel internationally

Responsibilities

  • Oversee key regulatory consulting and operational services throughout the entire product lifecycle. Lead strategic growth strategies and ensure continual improvement in the delivery of:
  • Global Regulatory Clinical Trial Support
  • Global Regulatory Strategic and Advisory Consulting Services
  • Global Chemistry Manufacturing and Controls and Quality Services
  • Global Labeling Strategy and Operations Services
  • Global Project Management Services
  • Regulatory Operations Services
  • Regulatory Information Management
  • Publishing
  • Technology Management and Support
  • Global Medical Devices
  • Drive functional activities to meet or exceed global revenue and margin targets.
  • Partner with Finance to set budgets, track project revenue, manage costs, and forecast future revenue.
  • Oversee global Business Development activities within regulatory functions including the bundling and cross selling of services to customize service offerings to meet client needs.
  • Support broader ICON Business Development needs and build service offering awareness internally and externally.
  • Establish and maintain customer relationships in a consultative, operational, and business development capacity.
  • Build and maintain an optimal global organizational structure, allocating resources to projects and initiatives.
  • Oversee staff hiring, manage performance expectations, develop staff, and plan for succession.
  • Ensure all projects are delivered on time, to quality expectations, and in compliance with ethical, legal, and regulatory standards.
  • Act as a Strategic Regulatory Advisor to customers and internal stakeholders, providing effective and timely regulatory advice.
  • Oversee the preparation, review, and submission of all key regulatory documents such as Marketing Authorization Applications (MAAs), New Drug Applications (NDAs), Clinical Trial Applications (CTAs), and Investigational New Drugs (INDs), Lifecycle management and Maintenance Submissions.
  • Provide regulatory input and oversee regulatory agency meetings.
  • Maintain a system of regulatory intelligence at global, regional, and local levels.
  • Oversee the development, implementation, and maintenance of validated technology and operational processes to support future operations.
  • Apprise executive management of key regulatory developments within the industry that may impact ICON’s business.
  • Represent ICON at external meetings and in regulatory forums.
  • Ensure corrective and preventative actions are taken in a timely manner to address issues.
  • Recognize and adhere to ICON's values centered around People, Clients, and Performance.
  • Foster a culture of process improvement aimed at streamlining processes, adding value to the business, and meeting client needs.

FAQs

What is the job title for this position?

The job title is Vice President, Global Regulatory Affairs Consulting Services.

Where is this role based?

This role is based in Ireland or the UK.

Is this position remote?

Yes, this position offers a hybrid work format.

What type of organization is ICON plc?

ICON plc is a world-leading healthcare intelligence and clinical research organization.

What qualifications are required for this position?

A Bachelor's degree in Life Sciences, Business Administration, or a related field is required; a Master's degree or MBA is preferred.

How many years of experience are required for candidates?

Candidates are required to have 10+ years of experience in global regulatory affairs within a CRO environment or industry position.

What are some of the key responsibilities of this role?

Key responsibilities include overseeing regulatory consulting services, managing revenue and budgets, leading business development activities, and providing regulatory advice to clients and stakeholders.

What is the required leadership experience for this position?

Candidates must have proven leadership experience in managing large, global cross-functional teams.

What type of travel is expected for this role?

The position requires the ability to travel internationally.

What benefits does ICON offer to its employees?

ICON offers various benefits, including annual leave entitlements, health insurance offerings, retirement planning, an Employee Assistance Programme, life assurance, and flexible country-specific optional benefits.

How can I apply for this job?

Interested candidates can apply for the job through ICON's careers site.

Does ICON have a commitment to diversity and inclusion?

Yes, ICON is committed to providing a workplace free of discrimination and harassment and values diversity and inclusion.

What should I do if I need a reasonable accommodation during the application process?

If you need a reasonable accommodation due to a medical condition or disability, you should let ICON know or submit a request as indicated in the job posting.

image

ICON plc

Science & Healthcare
Industry
10,001+
Employees

Mission & Purpose

Since our foundation in Dublin, Ireland in 1990, our mission has been to help our clients to accelerate the development of drugs and devices that save lives and improve quality of life. We do this by delivering best in class information, solutions and performance, with an unyielding focus on quality at all times. We offer a full range of consulting, development and commercialisation services from a global network of offices in 53 countries. We focus our innovation on the factors that are critical to our clients – reducing time to market, reducing cost, and increasing quality – and our global team of experts has extensive experience in a broad range of therapeutic areas.