Director/Sr Director, Regulatory Operations
The Director/Sr Director, Regulatory Operations will be responsible for execution and coordination of global regulatory submissions (INDs, DMFs, CTAs, etc.) in collaboration with internal program teams. The candidate will also create processes and implement systems for compliant regulatory submissions to global health authorities. The candidate will serve as the administrator for Beam’s regulatory information management system. This position is a key contributor to enable high-quality and timely regulatory submissions.
- Provides direct support to program teams and functional disciplines responsible for developing and delivering components for regulatory submissions.
- Manages all aspects of global submissions, publishing, validation, and Regulatory system implementations.
- Interacts with and monitors vendors to support publishing and systems.
- Organize and maintain regulatory correspondence and archives to prepare for migration into RIM system.
- Develops and manages day-to-day submission plans in accordance with program timelines in collaboration with CRO publishing partners.
- Develops processes and works collaboratively with other functions to maintain systems for electronic submissions and publishing in a validated state.
- Works across all disciplines to develop and maintain a comprehensive set of e-submission document templates.
- Serves as the administrator for Beam’s regulatory information management system and provide Subject Matter Expertise to support project teams in the development of components for various regulatory submissions.
- Develops and maintains efficient tracking mechanisms for all global regulatory information including the archiving and storage of both electronic and hard copy records (if applicable).
- Monitors evolving global regulatory guidance/regulations and ensures Beam’s regulatory submissions comply with all document/file formats and structures.
- Authors and/or collaborates on standard operating procedures for the regulatory operations function.
- Perform other related duties as assigned.
- Associates or bachelor’s degree in a scientific discipline or systems technology or equivalent experience.
- 10-12 years of pharmaceutical experience working in a regulated, life science environment (pharmaceutical, biotechnology, consumer health).
- Strong expertise and working knowledge of eCTD publishing systems, EDMS technology, and related publishing tools.
- Advanced knowledge of North American/Global submission standards (FDA, Health Canada, EMA, ICH, eCTD, etc.) and industry trends for dossier preparation (INDs, CTAs, etc.).
- Computer proficiency in Microsoft Office including Word, Excel, PowerPoint, and Project.
- 5 years of technical support and Information Management experiences from User support and strategic level, preferably within a corporate environment supporting multi-user systems.