Associate Director Regulatory Affairs (Operations)

Associate Director, Regulatory Affairs Operations

Key Accountabilities
- Lead planning, coordination, and execution of global regulatory submissions (INDs, CTAs, NDAs, BLAs, MAAs, amendments), ensuring compliance and timelines.
- Provide operational oversight of eCTD submission activities with external publishing vendors and internal stakeholders.
- Partner with the Senior Director to establish internal publishing capabilities and lead implementation of publishing capability strategy.
- Maintain accurate regulatory documentation, submission records, and data in regulatory information and document management systems.
- Oversee regulatory document management, tracking, and archival for completeness, accuracy, and inspection readiness.
- Serve as system administrator/SME for regulatory systems (e.g., Veeva RIM), driving training, user adoption, and support.
- Ensure adherence to global submission standards (eCTD structure, formatting, publishing requirements).
- Drive continuous improvement of regulatory operations processes, tools, and best practices.
- Lead, mentor, and develop a small regulatory operations team.
- Oversee vendor relationships and outsourced publishing activities (performance, quality, cost).
- Partner with Regulatory Affairs to operationalize global submission strategies.
- Collaborate cross-functionally (clinical, quality, CMC) and monitor milestones; identify risks and drive mitigations.
- Ensure compliance, inspection readiness, and integrity/accuracy/completeness of regulatory records.
- Manage submission timelines/milestones across programs; lead risk assessment, escalation, and resolution.

Education and Experience / Requirements
- Bachelor’s degree in Life Sciences or related discipline (required).
- 9+ years in Regulatory Affairs or Regulatory Operations (pharma/biotech), including 2+ years demonstrated leadership (required).
- Experience with RIMS/EDMS and electronic publishing tools; Veeva Vault Regulatory required.
- Strong knowledge of drug development process and global regulatory frameworks.
- Desirable: experience overseeing external publishing service providers.
- Advanced Microsoft Office (Word, Excel, PowerPoint) and Teams; project planning/tracking tools (e.g., Smartsheet, MS Project).
- Strong knowledge of global submission standards (FDA, EMA, ICH, eCTD).
- Expertise in eCTD publishing and lifecycle management; deep CTD/eCTD and tools (e.g., MS Word authoring templates, Adobe Acrobat, document management tools such as CSC Toolbox/Lorenz DocuBridge).
- Strong leadership, organizational, cross-functional communication, and project management.
- Fluency in English; additional European language is an asset.