Regulatory Manager

• Research existing product data against global or regional regulatory requirements
• Prepare gap analyses, product development plans, and regulatory submissions
• Prepare administrative and technical components of submissions for INDs, pre-approval packages, product registrations, and post-approval maintenance
• Prepare briefing packages for regulatory agency meetings or scientific advice
• Contribute to and support regulatory agency interactions
• Manage and operationalize day-to-day regulatory activities within timelines, scope, budgets, and strategies
• Provide regulatory support on multidisciplinary product development teams throughout the product life cycle
• Act as a subject matter expert and troubleshoot project-related issues
• Prepare estimates for regulatory services in proposals
• Support client meetings concerning proposals, project status, and business development
• Ensure compliance with global regulatory requirements and company policies and processes
• Prepare training materials and share regulatory best practices internally and externally
• Participate in internal and external project audits
• Support internal cross-functional initiatives
• Create and maintain SOPs and process documentation
• Provide oversight support to team members executing project responsibilities
• Identify when additional line support is needed
• Maintain individual training records and complete required training

• Minimum 10+ years of experience in regulatory affairs
• Functional lead experience leading a team
• Risk assessment capability, strategic thinking, decision-making, and project leadership
• Experience handling internal and external stakeholders
• M. Pharm degree
• Experience with CMC Module 3
• Experience authoring CMC sections of post-approval variations and life cycle management activities
• EU and GCC market experience
• Master's degree, preferably in a science-related field, or equivalent experience in a science/regulatory/medical writing-related field
• Moderate pharmaceutical/medical device-related experience
• Experience contributing to regulatory submissions such as IND, PMA, NDA, MAA, and CTD, including electronic submissions
• Excellent written and verbal communication skills
• Excellent customer service skills and ability to work independently and as part of a team
• Good quality management skills
• Advanced Microsoft Office skills
• Ability to interact with staff from multiple departments and offices to establish project standards
• Initiative, adaptability, and proactivity
• Strong analytical skills and attention to detail
• Ability to work concurrently on multiple projects with differing instructions
• Fluency in spoken, written, and read English

• Career development and progression
• Supportive and engaged line management
• Technical and therapeutic area training
• Peer recognition
• Total rewards program
• Inclusive culture
• Reasonable accommodations when appropriate