Director, Regulatory Operations
Keros Therapeutics
5 days ago
Remote friendly (Lexington, MA)
United States
Operations
Job Summary:
Reporting to the Head Regulatory Affairs, the Director of Regulatory Operations will be responsible for establishing the Regulatory Operations role at Keros and supporting growing regulatory needs, including in-house publishing and coordination with external vendors.
Primary Responsibilities:
- Oversee Regulatory Operations deliverables: Health Authority correspondence/submission archives; Veeva Vault Regulatory Information Management (RIM) administration; submission management; training of associated business processes.
- Implement training strategies, develop training materials, and lead training for Vault RIM adoption.
- Manage user groups/workflows and maintain archives of Health Authority interactions.
- Develop/manage/distribute reports, dashboards, and templates.
- Contribute to writing/reviewing/implementing 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 RIM regulations, best practices, and guidelines.
- Provide eCTD/CTD publishing services (rendering, bookmarking, hyperlinking, compilation, TOC creation, QC) for regulatory submissions.
- Coordinate publishing deliverables; primary point of contact across Regulatory Affairs, CMC, Labeling, etc. for major submissions (IND, BLA).
- Write/review internal work instructions and SOPs for submission preparation (electronic or paper).
- Create/update/maintain submission templates meeting global regulatory requirements.
Qualifications:
- BA/BS or equivalent experience.
- 12+ years industry experience, including 7+ years in regulatory operations.
- Attention to detail; ability to work independently, in multi-disciplinary teams, and with external partners/vendors.
- Prior experience running large-scale RA projects in biotech.
- Extensive knowledge of eCTD/e-publishing and regulatory management systems (e.g., Veeva RIM).
- Proficient in MS Word, Excel, PowerPoint, Adobe Acrobat, and Veeva Vault RIMs.
- Thrives in a collaborative, fast-paced environment.
Reporting to the Head Regulatory Affairs, the Director of Regulatory Operations will be responsible for establishing the Regulatory Operations role at Keros and supporting growing regulatory needs, including in-house publishing and coordination with external vendors.
Primary Responsibilities:
- Oversee Regulatory Operations deliverables: Health Authority correspondence/submission archives; Veeva Vault Regulatory Information Management (RIM) administration; submission management; training of associated business processes.
- Implement training strategies, develop training materials, and lead training for Vault RIM adoption.
- Manage user groups/workflows and maintain archives of Health Authority interactions.
- Develop/manage/distribute reports, dashboards, and templates.
- Contribute to writing/reviewing/implementing 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 RIM regulations, best practices, and guidelines.
- Provide eCTD/CTD publishing services (rendering, bookmarking, hyperlinking, compilation, TOC creation, QC) for regulatory submissions.
- Coordinate publishing deliverables; primary point of contact across Regulatory Affairs, CMC, Labeling, etc. for major submissions (IND, BLA).
- Write/review internal work instructions and SOPs for submission preparation (electronic or paper).
- Create/update/maintain submission templates meeting global regulatory requirements.
Qualifications:
- BA/BS or equivalent experience.
- 12+ years industry experience, including 7+ years in regulatory operations.
- Attention to detail; ability to work independently, in multi-disciplinary teams, and with external partners/vendors.
- Prior experience running large-scale RA projects in biotech.
- Extensive knowledge of eCTD/e-publishing and regulatory management systems (e.g., Veeva RIM).
- Proficient in MS Word, Excel, PowerPoint, Adobe Acrobat, and Veeva Vault RIMs.
- Thrives in a collaborative, fast-paced environment.