Regulatory Affairs Specialist

Position Summary The Regulatory Affairs Specialist is responsible for supporting regulatory submissions and compliance activities for pharmaceutical, biotechnology, medical device, or related regulated products. This role manages regulatory documentation, supports post-approval changes, provides regulatory strategy, and ensures compliance with applicable domestic and international regulatory requirements. The position serves as a regulatory subject matter expert, collaborating cross-functionally to support product lifecycle management, regulatory submissions, labeling updates, and compliance initiatives. Key Responsibilities Plan, author, compile, and submit regulatory filings and reports in electronic Common Technical Document (eCTD) format in accordance with applicable regulatory requirements. Review and assess Chemistry, Manufacturing, and Controls (CMC) changes and provide regulatory guidance for proposed post-approval modifications. Serve as the regulatory lead for cross-functional teams on regulatory requirements and submission strategies as needed. Prepare and submit post-approval regulatory supplements, amendments, and notifications. Author and review updates to product labeling and related regulatory documentation. Monitor and interpret current regulatory guidelines, requirements, and industry trends. Maintain regulatory databases, records, and tracking systems. Support electronic document management systems and regulatory information management processes. Provide mentorship and guidance to junior regulatory affairs professionals. Collaborate with quality, manufacturing, technical operations, research and development, and other stakeholders to ensure regulatory compliance throughout the product lifecycle. Author, organize, compile, and review electronic regulatory submissions and supporting documentation. Evaluate regulatory risks and recommend strategies to support business objectives while maintaining compliance. Manage multiple projects, deadlines, and priorities in a dynamic environment. Stay current with evolving regulatory requirements through training, professional development, and industry engagement. Analyze and resolve complex regulatory issues and provide recommendations for appropriate actions. Critically review technical and scientific documentation to ensure accuracy, completeness, and regulatory compliance. Support inspections, audits, and regulatory inquiries as required. Maintain compliance with applicable domestic and international regulations, standards, and guidelines, including Good Manufacturing Practices (GMP) and other industry-specific requirements. Qualifications Bachelor's degree in a scientific discipline or equivalent combination of education and experience. Minimum of five (5) years of regulatory affairs experience within a regulated industry. Regulatory Affairs Certification (RAC) preferred. Experience coordinating cross-functional projects and driving initiatives to successful completion. Project leadership, mentoring, or supervisory experience preferred. Strong understanding of regulatory submission processes, product lifecycle management, and change control systems. Experience working with electronic document management systems and change management platforms. Proficiency with Microsoft Office Suite and Adobe Acrobat. Excellent organizational, analytical, and problem-solving skills. Strong written and verbal communication skills with the ability to communicate effectively across multiple departments and organizational levels. Ability to manage multiple priorities while maintaining a high level of accuracy and attention to detail. #J-18808-Ljbffr