Director, Regulatory Strategy & Submissions

ICON Clinical Research; Reading; On-site; GBP 120,000 - 180,000; Full time

Benefits offered by this job

Annual leave

Health insurance

Retirement planning

Employee Assistance Programme

Life assurance

Country-specific benefits

Job summary

ICON plc is seeking a Director of Regulatory Affairs to provide strategic regulatory leadership across pharma and biotech projects in the UK. You will drive regulatory strategies, oversee submissions (MAAs CP/MRP/DCP), and guide lifecycle management to ensure compliant, timely deliverables.

You will lead cross-functional teams, interact with regulatory authorities (including Scientific Advice), and ensure alignment with business goals.

Qualifications

• Bachelor's degree in a relevant scientific discipline or healthcare field; advanced degree preferred.
• Extensive regulatory affairs experience in clinical research or pharma, with European procedures (CP/DCP) and post-authorization activities.
• Strategic ability in developing regulatory strategies (TPPs, CDPs) and leading submissions.
• Strong leadership for cross-functional teams and complex projects.
• Excellent communication and agency negotiation skills; travel ~25%.

Responsibilities

• Lead regulatory affairs activities and provide strategic direction across projects.
• Oversee preparation, authoring, and submission management of regulatory documents, including MAAs (CP, MRP, DCP).
• Manage European regulatory pathways, including Orphan, PIPs, and PRIME.
• Lead agency interactions and Scientific Advice meetings, coaching SMEs.
• Provide regulatory intelligence and interpretation of legislation to guide decisions.

Skills

Regulatory strategy

Leadership

Stakeholder management

Agency negotiation

Travel willingness

Education

Bachelor's degree in a relevant scientific discipline

Advanced degree preferred

Job description

ICON plc is seeking a Director of Regulatory Affairs to provide strategic regulatory leadership across pharma and biotech projects in the UK. You will drive regulatory strategies, oversee submissions (MAAs CP/MRP/DCP), and guide lifecycle management to ensure compliant, timely deliverables.

You will lead cross-functional teams, interact with regulatory authorities (including Scientific Advice), and ensure alignment with business goals.