Job Description

An innovative biotech is seeking an Associate Director Regulatory Affairs to lead international submissions and drive CTA submission strategy. This team is composed of world-class scientists and innovators who are leading the charge of integrating advanced imaging and AI technologies to revolutionize drug discovery.

The Associate Director Regulatory Affairs will be responsible for leading the development and execution of regulatory strategies for ex-US CTA submissions. The ideal candidate will have a strong understanding of global regulatory requirements and guidelines to ensure compliance, manage submissions, foster cross-functional collaboration, and serve as a liaison with regulatory agencies.

Key Responsibilities

• Design and implement regulatory strategies for clinical trial applications (CTAs) outside the U.S., ensuring alignment with organizational goals and timelines.
• Lead the preparation, review, and coordination of regulatory submission packages across multiple regions (EU, UK, LATAM, APAC, etc.)
• Develop dossier content plans in collaboration with internal stakeholders.
• Oversee the lifecycle management of international CTAs.
• Provide strategic input and support to cross-functional teams in preparing responses to health authority inquiries.

• Monitor and interpret evolving global regulatory requirements, guidelines, and industry standards.
• Ensure all clinical trial activities comply with applicable international regulations, including EU-CTR (Regulation EU No 536/2014), ICH guidelines, and country-specific legislation.

• Serve as the primary contact for regulatory authorities regarding submissions and follow-ups.

• Ensure regulatory compliance with quality systems, including GCP and GDPR.
• Identify potential regulatory risks and recommend mitigation strategies proactively.

Qualifications

• Bachelor's degree with 10+ years of relevant experience, or advanced degree with 8+ years in a scientific or regulatory discipline.
• Hands on experience supporting multiple CTA filings
• Deep understanding of international regulatory frameworks and submission platforms (e.g., CTIS, IRIS).
• Experience with documentation required by global health authorities, including clinical and GMP-related materials.
• Strong communication, negotiation, and project management capabilities.
• Proven success in cross-functional collaboration and regulatory strategy execution.
• Comfortable working in a dynamic, fast-paced environment.
• Proficiency in digital tools including Veeva Vault, Microsoft Office Suite, and other regulatory systems.

Job Tags

Similar Jobs