Senior Specialist, Regulatory Affairs – Operations

Job Description

Support the planning, coordination, and execution of global regulatory submissions, including INDs, CTAs, BLAs, NDAs, MAAs, and amendments. Ensure compliance with global regulatory requirements and timelines. Interface with external publishing vendors for submission preparation and internal stakeholders for operational oversight of eCTD regulatory submission activities. Maintain regulatory documentation, submission records, and regulatory information within regulatory systems and document management platforms. Oversee regulatory document management, tracking, and archival activities. Support regulatory systems (e.g., Veeva RIM) and provide training and support to internal stakeholders. Coordinate regulatory submission activities, including document readiness, publishing, quality control, and electronic submission processes. Support preparation and coordination of regulatory agency interactions, including briefing document planning and submission logistics. Monitor and track submission deliverables and milestones, identify risks, and proactively 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. Support lifecycle management activities, including post-approval submissions, amendments, annual reports, and regulatory correspondence.

Qualifications

1. Bachelor’s degree in Life Sciences or a related field. 2. Minimum of 5 years of experience in Regulatory Affairs or Regulatory Operations within the pharmaceutical or biotechnology industry. 3. Experience with Regulatory Information Management Systems (RIMS), Electronic Document Management Systems (EDMS), and electronic publishing tools; Veeva Vault Regulatory experience is required. 4. Strong knowledge of the drug development process and global regulatory frameworks. 5. Experience coordinating with/overseeing external publishing service providers. 6. Advanced proficiency with Microsoft Office Suite and collaboration tools like Microsoft Teams. 7. Experience using project planning and tracking tools (e.g., Smartsheet, Microsoft Project). 8. Knowledge of global regulatory submission standards and requirements (FDA, EMA, ICH guidelines, eCTD). 9. Demonstrated experience compiling, validating, and submitting regulatory dossiers in eCTD format. 10. Experience with CTD/eCTD structure, format, and submission requirements, and proficiency in MS Word, Adobe Acrobat, electronic publishing software, and document management systems. 11. Strong organizational, communication, and project management skills. 12. Ability to work effectively in a collaborative, fast-paced environment. 13. Fluency in English; proficiency in an additional European language is an asset.

Benefits

- Competitive salaries - Annual performance-based bonuses - Equity-based incentive program - Generous vacation - Paid wellness days - Support for learning and development