Associate Director, Regulatory Affairs – Operations

This is a fully remote position, open to applicants in United States.

📋 Description

• Spearhead the planning, coordination, and implementation of worldwide regulatory submissions (such as INDs, CTAs, NDAs, BLAs, MAAs, and amendments), ensuring adherence to global regulatory standards and timelines.

• Offer operational supervision of eCTD submission activities, collaborating with external publishing vendors and internal stakeholders to guarantee high-quality, timely outputs.

• Collaborate with the Senior Director of Regulatory Operations to play a pivotal role in establishing internal publishing capabilities, which includes defining and leading the execution of the publishing capability strategy.

• Ensure precise maintenance of regulatory documentation, submission records, and data within regulatory information management and document management systems.

• Supervise regulatory document management, tracking, and archival processes to ensure completeness, accuracy, and readiness for inspection.

• Act as the system administrator for regulatory systems (such as Veeva RIM) and serve as the internal subject matter expert (SME), promoting training, user adoption, and ongoing support in alignment with the defined system strategy and roadmap.

• Guarantee compliance with global submission standards, including eCTD structure, formatting, and publishing requirements.

• Lead the development and ongoing enhancement of regulatory operations processes, tools, and best practices to improve efficiency, quality, and consistency.

• Guide, mentor, and nurture a small team of regulatory operations staff, fostering a high-performance and collaborative team environment.

• Manage vendor relationships and outsourced publishing activities, ensuring performance, quality, and cost-effectiveness.

• Collaborate with Regulatory Affairs leads to implement global submission strategies.

• Work cross-functionally with clinical, quality, and CMC teams to ensure alignment and execution of submission plans.

• Track submission milestones and deliverables, proactively identifying risks and implementing mitigation strategies to avert delays.

• Maintain compliance with global regulatory standards and organizational policies.

• Ensure inspection readiness and assist with internal and external audits.

• Safeguard the integrity, accuracy, and completeness of regulatory records and documentation.

• Manage submission timelines, milestones, and deliverables across various programs.

• Conduct risk assessments, escalations, and resolutions to ensure the successful execution of regulatory activities.

⛳️ Requirements

• A Bachelor’s degree in Life Sciences or a related field is mandatory.

• At least 9 years of pertinent experience in Regulatory Affairs or Regulatory Operations within the pharmaceutical or biotechnology sector, including a minimum of 2 years in a leadership role.

• Proficiency in Regulatory Information Management Systems (RIMS), Electronic Document Management Systems (EDMS), and electronic publishing tools; experience with Veeva Vault Regulatory is essential.

• Comprehensive understanding of the drug development process and global regulatory frameworks.

• Experience in managing or overseeing external publishing service providers for regulatory submissions is preferred.

• Advanced skills in Microsoft Office Suite (Word, Excel, PowerPoint) and collaboration tools such as Microsoft Teams.

• Familiarity with project planning and tracking tools (e.g., Smartsheet, Microsoft Project, or similar) to support regulatory timelines and deliverables.

• Strong knowledge of global regulatory submission standards and requirements, including FDA, EMA, ICH guidelines, and eCTD submission formats.

• Expertise in eCTD publishing and lifecycle management.

• Profound understanding of global regulatory submission requirements.

🏝️ Benefits

• Competitive salaries

• Annual performance-based bonuses

• Equity-based incentive program

• Generous vacation

• Paid wellness days

• Support for learning and development