Note: The job is a remote job and is open to candidates in USA. Keros Therapeutics is a biotechnology company developing therapies that modulate TGF-β signaling to address disorders affecting blood cells and multiple tissues. The Director of Regulatory Operations will establish and lead the Regulatory Operations function, overseeing regulatory information management, eCTD/CTD publishing, submission coordination, training, systems, and related processes.
Responsibilities
- Oversee all Regulatory Operations deliverables, including management of Health Authority correspondence/submission archives, business administration of the Veeva Vault Regulatory Information Management system, submission management, and training of associated business processes
- Implement training strategies, develop training materials, and lead training delivery for effective adoption of Vault RIM
- Manage user groups and workflows and create and maintain archives of Health Authority interactions
- Develop, manage, and distribute reports, dashboards, and templates to meet user needs
- Contribute to the writing, review, and implementation of standards and procedures related to regulatory information management
- Partner with IT and Quality to support system validation activities
- Maintain proficiency in Vault RIM and maintain current knowledge of regulations, best practices, and guidelines related to RIM
- Provide eCTD/CTD publishing services including rendering, bookmarking, hyperlinking, compilation, table of contents creation and QC regulatory submissions to Regulatory agencies
- Coordinate publishing deliverables and act as the primary point of contact for various regulatory functions (Regulatory Affairs, CMC, Labeling, etc.) for major submissions (IND, BLA, etc.)
- Write or review internal work instructions and standard operating procedures (SOPs) pertaining to submission preparation (electronic or paper)
- Create, update and maintain submission templates that meet global regulatory requirements
Skills
- BA/BS or equivalent experience
- At least 12+ years of industry experience with at least 7+ years experience in regulatory operations
- Attention to detail and the ability to work individually, within a multi-disciplinary team, as well as with external partners and vendors
- Prior experience running large scale RA projects within the biotech industry
- Extensive knowledge of eCTD, e-publishing systems for preparing regulatory submissions as well as regulatory management systems (e.g. Veeva RIM)
- Experienced in MS Word, Excel, PowerPoint, and Adobe Acrobat, Veeva Vault RIMs
- Ability to thrive in a collaborative and fast-paced team environment
Benefits
- Mentoring, coaching, and development for all Keros team members
Company Overview