Senior Specialist, Regulatory Affairs – Operations

📋 Description

• Assist in the planning, coordination, and execution of global regulatory submissions, which include INDs, CTAs, BLAs, NDAs, MAAs, and amendments, ensuring adherence to global regulatory standards and timelines.

• This position interacts with external publishing vendors for the preparation of submissions, as well as with internal stakeholders to provide operational oversight and support for eCTD regulatory submission activities.

• Maintain regulatory documentation, submission records, and relevant information within regulatory systems and document management platforms.

• Supervise regulatory document management, tracking, and archival processes.

• Support regulatory systems (e.g., Veeva RIM) and act as an internal subject matter expert (SME) to provide training and assistance to internal stakeholders.

• Coordinate regulatory submission tasks including document readiness, publishing, quality control, and electronic submission (eCTD) processes.

• Aid in the preparation and operational coordination of regulatory agency interactions, encompassing briefing document planning and submission logistics.

• Monitor and track submission deliverables and milestones, identifying risks and proactively collaborating with stakeholders to mitigate potential delays.

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

• Contribute to the development and implementation of regulatory operations processes, tools, and best practices to enhance efficiency and consistency across programs.

• Support lifecycle management activities, which include post-approval submissions, amendments, annual reports, and regulatory correspondence.

⛳️ Requirements

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

• A minimum of 5 years of relevant experience in Regulatory Affairs or Regulatory Operations within the pharmaceutical or biotechnology sectors.

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

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

• Experience in coordinating with or supervising external publishing service providers for regulatory submissions is preferred.

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

• Experience with project planning and tracking tools (e.g., Smartsheet, Microsoft Project, or similar) to assist in meeting regulatory timelines and deliverables.

• Knowledge of global regulatory submission standards and requirements, including those from the FDA, EMA, ICH guidelines, and eCTD submission formats.

• Proven experience in compiling, validating, and submitting regulatory dossiers in eCTD format.

• Familiarity with CTD/eCTD structure, format, and submission requirements, with proficiency in MS Word (e.g., authoring templates), Adobe Acrobat, electronic publishing software, and document management systems (e.g., CSC Toolbox, Lorenz DocuBridge, or equivalent); advanced or expert-level knowledge is a plus.

• Excellent organizational, communication, and project management skills, capable of managing multiple priorities simultaneously and evaluating the impact of changes on project timelines.

• Ability to work effectively in a collaborative, fast-paced, mid-sized company environment.

• Proficiency in English (spoken, written, and reading); knowledge of an additional European language is an advantage.

🏝️ Benefits

• Competitive salaries

• Annual performance-based bonuses

• Equity-based incentive program

• Generous vacation

• Paid wellness days

• Support for learning and development