AD – Director, Regulatory Affairs – FSP Team

Thermo Fisher Scientific

. Develop and execute regulatory strategy for assigned development programs .

Posted 9/23/2026full-timeRemote • North Carolina • United StatesLeadWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in Regulatory Affairs with a focus on European drug development, regulatory strategy, and submission processes. Capable of translating complex regulatory information into actionable recommendations while maintaining compliance and quality standards.

Highest-signal resume keywords

Regulatory Strategy DevelopmentDossier PreparationHealth Authority InteractionPharmaceutical Legislation KnowledgeProject Leadership

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Regulatory AffairsEuropean Drug DevelopmentSubmission ReadinessRegulatory ComplianceICH GuidelinesGCP KnowledgeRisk Management PlansClinical Trial Regulatory ActivitiesRegulatory Submission CoordinationAssessment Question Preparation

Soft Skills

Strong CommunicationInfluencing SkillsNegotiation SkillsCollaborative ApproachIntellectual Curiosity

Industry Keywords

Pharmaceutical IndustryBiotechnology IndustryRegulatory RequirementsLifecycle ManagementCross-Functional CollaborationScientific Evidence InterpretationRegulatory QualityDecision-Making IntegrityEmerging Regulatory RisksStakeholder Partnerships

Tech Stack

Tools & technologies

Google Cloud Platform

About the role

Key responsibilities & impact

Develop and execute regulatory strategy for assigned development programs
Lead regulatory planning and execution, including pre-submission activities, dossier strategy, submission readiness, health authority review and lifecycle management
Coordinate cross-functional development and review of regulatory submissions
Work closely with Clinical, CMC, Nonclinical, Biostatistics, Medical Writing, Pharmacovigilance, Quality, Commercial and other functions
Lead preparation of responses to assessment questions, including Day 120 and Day 180 review milestones
Develop regulatory strategies, briefing packages and meeting preparation for health authority interactions
Lead or support regulatory activities
Provide regulatory leadership for clinical trial activities conducted through CTIS, including initial applications, substantial modifications and ongoing maintenance
Identify and communicate emerging regulatory risks, opportunities and requirements
Translate regulatory issues into pragmatic recommendations and mitigation plans
Contribute to labeling, product information, Risk Management Plans and other registration or post-authorization activities
Represent Regulatory Affairs on development teams and governance forums
Contribute to broader global regulatory strategy
Build partnerships across functions and external stakeholders
Facilitate timely decisions and resolve complex regulatory issues through scientific evidence, regulatory judgment and constructive challenge
Maintain regulatory quality, compliance and integrity of decision-making

Requirements

What you’ll need

Degree in life sciences, pharmacy, medicine or a related scientific discipline
Advanced degree preferred
Significant progressive Regulatory Affairs experience within the pharmaceutical or biotechnology industry
Strong expertise in European drug development and registration
Substantial involvement in regulatory strategy, dossier preparation, submission and health authority review
Practical experience preparing and coordinating responses to assessment questions and interacting with regulatory authorities
Strong knowledge of pharmaceutical legislation, procedures, ICH guidelines, GCP and applicable regulatory requirements
Ability to interpret complex scientific and regulatory information and translate it into clear, actionable recommendations
Strong communication, influencing, negotiation and project leadership skills
Ability to operate effectively across functions and organizational levels
Comfortable working independently and taking ownership of outcomes
Collaborative and solution-oriented approach, with intellectual curiosity, sound judgment and openness to alternative perspectives
Ability to balance speed and pragmatism with scientific rigor, regulatory compliance and high-quality execution

Benefits

Comp & perks

Fully remote work arrangement
Standard Monday–Friday work schedule
Domestic and international travel opportunities (approximately 10–20%, depending on program and business needs)