Regulatory Affairs Senior Associate

📋 Description

• • Assist US Regulatory Lead (USRL) in supporting US regulatory activities including development and submission of Investigational New Drug (IND) applications, Biologic License Applications (BLAs), and New Drug Applications (NDAs)
• • Provide and maintain documentation support for IND/BLA/NDA submissions such as annual reports and amendments in collaboration with the US Regulatory Lead
• • Create and maintain product regulatory history documents within the regulatory document management system and ensure proper archiving of all regulatory documents and agency communications
• • Review the US component of the Global Regulatory Strategic Plan (GRSP) and provide input to operational deliverables; conduct regulatory research to support GRSP content as delegated
• • Ensure regulatory compliance of all submissions to the US FDA and support adherence to regulatory standards
• • Prepare supportive documentation for regulatory deliverables including regulatory landscapes, research for regulatory strategy, and target product label development
• • Coordinate collection of functional documents from cross-functional teams to support regulatory applications
• • Participate on Global Regulatory Teams (GRT) and assist with meeting management including agenda preparation and minute-taking
• • Assist the US Regulatory Lead in managing the process for responding to FDA questions and requests
• • Coordinate Quality Check (QC) of regulatory documentation such as briefing packages and submission dossiers
• • Serve as primary author for routine regulatory correspondence including annual reports and other standard submissions
• • Prepare regulatory packages and cross-reference letters to support investigator-initiated studies
• • Complete required regulatory forms for agency communications such as FDA Form 1571
• • Support process improvement initiatives, standards development, and regulatory metrics tracking
• • Assist in the development and maintenance of regulatory templates and standardized documentation formats
• • Respond to specific requests from Global Regulatory Teams and communicate relevant regulatory issues to stakeholders
• • Support the development and execution of Global Regulatory Team goals and timelines
• • Work remotely within the United States with flexibility in work location as permitted by company policy
• • Collaborate with cross-functional teams including Clinical, Quality, and Medical Affairs to ensure regulatory alignment across programs
• • Maintain up-to-date knowledge of FDA regulations and guidance applicable to biologics and pharmaceutical products
• • Contribute to continuous improvement of regulatory workflows and documentation practices
• • Ensure all regulatory submissions meet internal quality standards and external regulatory requirements
• • Engage in training and development opportunities to enhance regulatory expertise and professional growth