Regulatory Affairs Director — Global Strategy

ThermoFisher Scientific; Wilmington (NC); On-site; USD 170,000 - 210,000; Full time

Job summary

Thermo Fisher Scientific is seeking an experienced Regulatory Affairs Associate Director/Director to provide strategic regulatory leadership for late-stage global development programs.

The role oversees regulatory strategy and execution through marketing authorization and lifecycle management, working across Clinical, CMC, Nonclinical, Biostatistics, Medical Writing, Pharmacovigilance, Quality, and Commercial teams.

Qualifications

• Significant progressive Regulatory Affairs experience in pharma/biotech.
• Strong expertise in European drug development and registration.
• Experience in strategy, dossier preparation, submission and health authority review.
• Experience coordinating responses to assessment questions with regulators.
• Knowledge of pharmaceutical legislation, ICH, GCP and regulatory requirements.
• Ability to translate complex data into actionable recommendations.
• Strong communication and leadership across functions.
• Independent and accountable with high-quality execution.

Responsibilities

• Develop and execute regulatory strategy for development programs.
• Lead regulatory planning and submission readiness.
• Coordinate cross-functional reviews of regulatory submissions.
• Prepare responses to assessment questions and key milestones.
• Manage interactions with authorities and prepare meetings.
• Provide regulatory leadership for CTIS activities.
• Identify regulatory risks and mitigation plans.
• Contribute to labeling, risk management, and post-authorization activities.
• Represent Regulatory Affairs on teams and governance forums.
• Build partnerships across functions and external stakeholders.

Skills

Regulatory leadership

Strategic planning

Cross-functional collaboration

Communication skills

Project leadership

Regulatory strategy

Risk management

Education

Life sciences degree

Advanced degree

Job description

Thermo Fisher Scientific is seeking an experienced Regulatory Affairs Associate Director/Director to provide strategic regulatory leadership for late-stage global development programs.

The role oversees regulatory strategy and execution through marketing authorization and lifecycle management, working across Clinical, CMC, Nonclinical, Biostatistics, Medical Writing, Pharmacovigilance, Quality, and Commercial teams.