Principal Regulatory Affairs Specialist

About This Role

This role involves serving as a lead for regulatory affairs across multiple countries and projects, providing strategic guidance for product development from preclinical stages through registration and optimization. The Principal Regulatory Affairs Specialist will ensure compliance with regulatory standards and act as a liaison for internal and external clients.

Responsibilities

• Provide senior review of regulatory documents and submissions to ensure high quality standards that meet or exceed client expectations and regulatory requirements
• Act as a subject matter expert in providing regulatory strategy advice to internal and external clients on moderately complex projects
• Provide internal clients with up-to-date legislation and guidance as it becomes available
• Participate in project management activities and act as a liaison with internal and external clients for marketing regulatory services
• Provide matrix/project leadership, training, and guidance to junior team members to support understanding of regulations and project deliverables
• Ensure adherence to project budgets, time schedules, and scope of work
• Ensure compliance with relevant organizational and regulatory SOPs and WPDs
• Contribute to business development activities, including project budgeting/forecasting

Requirements

• Bachelor's degree or equivalent
• 8+ years of relevant experience
• Excellent English language (written and oral) communication skills
• Great attention to detail and quality, with excellent editorial/proofreading skills
• Strong interpersonal skills
• Strong computer skills (Microsoft Word, Excel, PowerPoint)
• Solid organizational, time management, and planning skills
• Strong negotiation skills
• Capable of working independently and exercising independent judgment
• Strong understanding of global/regional/national country requirements/regulatory affairs procedures for clinical trial authorization, licensing, lifecycle management
• Expert knowledge of ICH and other global regulatory guidelines
• Good understanding of regulatory specialty areas (preclinical, clinical, CMC, publishing)
• Strong understanding of medical terminology, statistical concepts, and guidelines
• Excellent analytical, investigative and problem-solving skills
• Solid understanding of budgeting and forecasting

Qualifications

• Bachelor's degree or equivalent and relevant formal academic / vocational qualification
• 8+ years of previous experience that provides the knowledge, skills, and abilities to perform the job

Skills

* Required skills