Associate Director/Director Regulatory Affairs

We are seeking an experienced Associate Director/Director of Regulatory Affairs to lead global regulatory submission activities across development programs. This strategic and hands-on role will be responsible for overseeing regulatory operations & submissions, ensuring timely, high-quality submissions in alignment with global health authority requirements.

Key Responsibilities:

• Lead planning, preparation, and submission of regulatory dossiers including INDs, CTAs, NDAs, and MAAs.
• Provide regulatory guidance to cross-functional teams including clinical, nonclinical, CMC, and commercial stakeholders.
• Manage responses to health authority queries (e.g., FDA, EMA, MHRA, Health Canada, TGA).
• Coordinate regulatory timelines, document workflows, and maintain submission compliance.
• Oversee publishing, formatting, and archiving of submissions per internal SOPs and regulatory standards.
• Serve as the primary liaison for internal teams, external vendors, and health authorities on regulatory operational matters.
• Administer the Regulatory Information Management system and support document control systems.
• Contribute to continuous process improvement within regulatory operations.

Qualifications:

• Bachelor’s degree required; advanced degree in a scientific field preferred.
• Minimum 8 years in the pharmaceutical or biotech industry, including 3+ years in regulatory affairs with direct IND/CTA/NDA/MAA experience.
• Strong knowledge of global regulatory requirements and electronic submission processes (e.g., eCTD).
• Proficiency with regulatory publishing tools and document management systems.
• Demonstrated project management skills and ability to thrive in a dynamic environment.
• Excellent communication, interpersonal, and organizational skills.