Director/Sr Director, Regulatory Operations
Company: Beam Therapeutics
Location: Cambridge
Posted on: November 19, 2023
Job Description:
Position Overview:
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.
Primary Responsibilities:
- 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.
Qualifications:
- 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.
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Keywords: Beam Therapeutics, Cambridge , Director/Sr Director, Regulatory Operations, Executive , Cambridge, Massachusetts
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