# Senior Manager - Regulatory Affairs

**Company**: ICON
**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/Senior-Manager--Regulatory-Affairs_JR161960?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply
**Canonical**: https://yubhub.co/jobs/job_b17e6272-ade

## Description

ICON is a global healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster.

As a Senior Manager, Regulatory Affairs at ICON, you will design and analyse clinical trials, interpreting complex medical data, and contribute to the advancement of innovative treatments and therapies.

**Responsibilities:**

- Participate in provision of regulatory expertise in strategic drug development across multiple areas.

- Take part in preparation of strategic development and submission plans.

- Be involved in the regulatory affairs activities across the ICON portfolio and be an expert and advisor to ICON clients (externally and internally).

- Be a trusted partner - represent the Regulatory Affairs Department in business development activities and generate new business opportunities.

- Contribute to at least two of the following areas: interactions with regulatory agencies, early phase consulting, development planning (PDP/RDP/CDP), scientific/agency advice, orphan drugs/pediatric development, medical devices

**Your Profile:**

- Bachelor's degree in a relevant scientific discipline or healthcare-related field

- EU/APAC: In-depth proven regulatory affairs expertise. Minimum of 7 years' experience, supervisory experience, and pharmaceutical/CRO industry experience.

- US/LATAM/CAN: A minimum of 7 years regulatory affairs experience including supervisory experience and a minimum of 6 years pharmaceutical/CRO industry.

- Demonstrable experience within regulatory affairs, including development of regulatory strategies, document writing, marketing authorization applications, clinical trials, post-licensing activities, and direct regulatory agency interaction.

- Strong organizational skills, ability to manage multiple tasks, and meticulous attention to detail.

- Excellent written, verbal, and management skills, as well as demonstrated presentation skills, problem-solving ability, strong interpersonal skills, and the ability to plan/organize.

**Rewards & Benefits**

- Competitive base salary and performance related incentives

- Health and wellbeing programmes including medical, dental, and vision coverage where applicable

- Retirement and pension plans

- Life assurance and disability coverage

- Employee assistance programmes and wellbeing resources

- Learning and development opportunities through structured training and career pathways

## Skills

### Required
- regulatory affairs
- clinical trials
- medical data analysis
- strategic drug development
- regulatory strategies
- document writing
- marketing authorization applications
- post-licensing activities

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