Director, Regulatory Operations

Job Summary:
Reporting to the Head Regulatory Affairs, the Director of Regulatory Operations will be responsible for establishing the Regulatory Operations function and supporting Keros’ regulatory needs, including in-house publishing and working with external vendors.

Primary Responsibilities:
- Oversee Regulatory Operations deliverables, including Health Authority correspondence/submission archives, Veeva Vault RIM administration, submission management, and training of business processes.
- Implement training strategies; develop training materials and lead training delivery for Vault RIM adoption.
- Manage user groups/workflows and maintain archives of Health Authority interactions.
- Develop, manage, and distribute reports, dashboards, and templates.
- Contribute to writing/reviewing/implementation of standards and procedures for regulatory information management.
- Partner with IT and Quality to support system validation activities.
- Maintain proficiency in Vault RIM and stay current on regulations/best practices for RIM.
- Provide eCTD/CTD publishing services (rendering, bookmarking, hyperlinking, compilation, table of contents creation, and QC of submissions).
- Coordinate publishing deliverables; act as primary point of contact for Regulatory Affairs/CMC/Labeling for major submissions (IND, BLA).
- Write or review work instructions and SOPs for submission preparation.
- Create, update, and maintain global regulatory submission templates.

Qualifications:
- BA/BS or equivalent experience.
- 12+ years industry experience; 7+ years in regulatory operations.
- Attention to detail; able to work with multidisciplinary teams, partners, and vendors.
- Experience running large-scale RA projects in biotech.
- Extensive knowledge of eCTD and regulatory management systems (e.g., Veeva RIM).
- Proficient in MS Word, Excel, PowerPoint, Adobe Acrobat, and Veeva Vault RIM.
- Ability to thrive in a collaborative, fast-paced environment.