AD – Director, Regulatory Affairs – FSP Team

This is a fully remote position, open to applicants in North Carolina.

📋 Description

• Formulate and implement regulatory strategies for designated development programs.

• Direct regulatory planning and execution, encompassing pre-submission activities, dossier strategy, submission readiness, health authority evaluation, and lifecycle management.

• Oversee the collaborative development and review of regulatory submissions across various functions.

• Collaborate closely with Clinical, CMC, Nonclinical, Biostatistics, Medical Writing, Pharmacovigilance, Quality, Commercial, and other departments.

• Spearhead the preparation of responses to assessment inquiries, including Day 120 and Day 180 review milestones.

• Craft regulatory strategies, briefing packages, and meeting preparations for interactions with health authorities.

• Lead or assist with regulatory initiatives.

• Provide regulatory guidance for clinical trial activities conducted through CTIS, including initial applications, substantial modifications, and ongoing maintenance.

• Identify and communicate emerging regulatory risks, opportunities, and requirements.

• Convert regulatory challenges into practical recommendations and mitigation strategies.

• Contribute to labeling, product information, Risk Management Plans, and additional registration or post-authorization activities.

• Represent Regulatory Affairs in development teams and governance forums.

• Contribute to a comprehensive global regulatory strategy.

• Establish partnerships across functions and with external stakeholders.

• Facilitate timely decision-making and resolve complex regulatory challenges through scientific evidence, regulatory expertise, and constructive dialogue.

• Uphold regulatory quality, compliance, and the integrity of decision-making.

⛳️ Requirements

• Bachelor’s degree in life sciences, pharmacy, medicine, or a related scientific field.

• Advanced degree is preferred.

• Extensive progressive experience in Regulatory Affairs within the pharmaceutical or biotechnology sectors.

• In-depth knowledge of European drug development and registration processes.

• Significant experience in regulatory strategy, dossier preparation, submissions, and health authority evaluations.

• Practical experience in preparing and coordinating responses to assessment inquiries and engaging with regulatory authorities.

• Strong understanding of pharmaceutical legislation, procedures, ICH guidelines, GCP, and relevant regulatory requirements.

• Capacity to interpret complex scientific and regulatory information and convey it as clear, actionable recommendations.

• Excellent communication, influencing, negotiation, and project leadership abilities.

• Proficient in working effectively across functions and organizational levels.

• Comfortable with independent work and taking ownership of outcomes.

• Collaborative and solution-focused mindset, coupled with intellectual curiosity, sound judgment, and receptiveness to alternative viewpoints.

• Ability to balance speed and practicality with scientific rigor, regulatory compliance, and high-quality execution.

🏝️ Benefits

• Fully remote work environment.

• Standard Monday to Friday work schedule.

• Opportunities for domestic and international travel (approximately 10-20%, depending on program and business requirements).