Regulatory Affairs Manager

Regulatory Manager

About the Role

The Regulatory Manager is responsible for managing regulatory submissions and maintaining regulatory documentation to ensure compliance with global marketing authorizations and global clinical trial applications. This role supports cross functional teams, contributes to regulatory strategy execution, and ensures regulatory requirements are consistently met across all assigned projects.

Responsibilities

• Maintain eCTD and IMPD documentation, ensuring consistency, accuracy, and continuous regulatory compliance
• Provide regulatory support for projects to ensure submission of Competent Authority application in line with project goals
• Support planning, preparation, and maintenance of regulatory documentation in collaboration with subject matter experts
• Contribute to development and submission of DSURs, PIPs/PSPs, Orphan Drug Designation applications, Fast Track applications, and other regulatory documents
• Provide regulatory support for expanded access/compassionate use programs (EAPs)
• Support preparation for Regulatory Agency interactions, including scientific advice meetings
• Review, quality check, and approve regulatory updates per internal procedures
• Maintain regulatory systems, databases, and trackers
• Participate in project team meetings, providing regulatory guidance
• Identify regulatory gaps and collaborate to implement solutions
• Maintain compliance with internal Quality Systems and applicable GxP standards
• Support QA in preparation for regulatory agency inspections
• Maintain current knowledge of relevant global legislation and guidance (UK, EU, USA, ICH)

Basic Qualifications

• BSc in Pharmacy, Biological Science, or related field
• Minimum 5 years pharmaceutical drug development experience, including 2 years in regulatory affairs
• Experience preparing INDs, CTAs, and marketing applications
• Knowledge of FDA, EU, MHRA, and ICH regulations and guidelines

Preferred Qualifications

• Strong problem solving skills and ability to implement solutions
• Experience supporting regulatory interactions and inspections
• Knowledge of expanded access/compassionate use program requirements

Expectations & Competencies

• Ability to write, review, and compile regulatory documents including IMPD, IB, eCTD
• Proficiency with Microsoft Word and Excel