# Global Regulatory Lead

**Company**: ICON Strategic Solutions
**Location**: Mechelen
**Experience**: senior
**Job type**: full-time
**Category**: Healthcare
**Industry**: Healthcare

**Apply**: https://icon.wd3.myworkdayjobs.com/en-US/broadbean_external/job/Belgium-Mechelen/Early-Developement-Global-Regulatory-Lead_JR162620?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply
**Canonical**: https://yubhub.co/jobs/job_82d735f1-170

## Description

As a Global Regulatory Lead at ICON Strategic Solutions, you will provide strategic regulatory leadership across the development lifecycle of innovative therapeutics.

You will work collaboratively with cross-functional stakeholders to drive patient-focused regulatory strategies, support accelerated development pathways, lead agency interactions, and ensure programs are positioned for successful transition into later-stage development.

Key responsibilities include:

- Providing strategic global regulatory leadership for assigned early development programs

- Developing and executing innovative global regulatory strategies

- Embedding patient-focused approaches into regulatory planning and development strategies

- Serving as a key member of the Early Development Regulatory Team

- Representing Regulatory Affairs within governance committees and development forums

- Partnering closely with asset teams to facilitate seamless transition of programs

- Collaborating with regulatory leadership to establish and enhance processes

- Mentoring, coaching, and developing members of the regulatory organization

- Building and maintaining strong relationships with internal stakeholders

- Monitoring, assessing, and communicating evolving global regulatory requirements

- Leading interactions with health authorities and overseeing external regulatory vendors

- Providing hands-on support for key regulatory submissions and interactions

Requirements:

- Bachelor's degree in Life Sciences, Pharmacy, Medicine, or related scientific discipline

- At least 5-7 years of experience leading global regulatory strategies and teams

- Deep knowledge of global regulatory frameworks

- Demonstrated experience supporting innovative therapies through early clinical development

- Proven expertise in developing and implementing global regulatory strategies

- Experience conducting health authority interactions and submissions

- Strong leadership skills with the ability to influence without authority

- Excellent verbal, written, presentation, and stakeholder management skills

- Strong project management, prioritization, and organizational capabilities

ICON offers a competitive and comprehensive total rewards package designed to support your health, wellbeing, and career development.

## Skills

### Required
- global regulatory strategies
- regulatory leadership
- patient-focused approaches
- health authority interactions
- project management

### Nice to have
- advanced scientific degree
- experience across both early and late-stage drug development
- scientific expertise in Immunology
- knowledge of diverse therapeutic modalities

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Source: [Apply at icon.wd3.myworkdayjobs.com](https://icon.wd3.myworkdayjobs.com/en-US/broadbean_external/job/Belgium-Mechelen/Early-Developement-Global-Regulatory-Lead_JR162620?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply)