Manage submission timelines and coordinate document deadlines across Regulatory, Clinical, CMC, Nonclinical, and Quality functions
Prepare, review, format, and publish high quality regulatory documents (e.g., IND/CTA, amendments, DSURs, meeting packages, eCTD modules) for FDA and other global regulatory agencies
Manage project communication and stakeholder expectations, providing transparent status updates and risk identification
Experience or familiarity with eCTD publishing systems and document management platforms (e.g., Veeva Vault, Egnyte, SharePoint)
Conduct technical quality checks, bookmarking, hyperlinking, and ensuring compliance with eCTD and regional requirements
Maintain submission archives and lifecycle management in accordance with regulatory guidance and internal SOPs
Track agency correspondence and commitments; assist in preparing responses to health authority requests
Support development and continuous improvement of regulatory processes, templates, and standards
Assist with regulatory intelligence monitoring
Support regulatory authority interactions
Contribute to inspection readiness and support regulatory audits, as needed

Requirements

Bachelor's or higher degree in a scientific discipline
Minimum of 5 years of experience in regulatory operations, regulatory affairs, or eCTD publishing within the biotech/pharmaceutical industry
Strong attention to detail, organizational skills, and ability to manage multiple tasks under tight timelines
Excellent written and verbal communication and interpersonal skills
Experience in a small or early-stage biotech environment
Strong knowledge of global investigational submission standards and processes (eCTD, FDA/EMA requirements, ICH guidelines)
Familiarity with regulatory publishing tools (e.g., Lorenz DocuBridge, Veeva RIM, GlobalSubmit, eCTDmanager) and document management systems
Team player, with the ability to develop collaborative relationships in an often remote online team environment

Benefits

90% employer-covered benefits
Flexible PTO
A very generous holiday schedule that includes a week off in August and time off around the winter holidays
A well-stocked kitchen with snacks and beverages
Additional benefits include the opportunity for annual bonuses, stock options, an Employee Stock Purchase Program, and a 401(k) with an employer match.
The comprehensive wellness program includes medical, dental, vision, and LTD coverage.

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools

regulatory operationsregulatory affairseCTD publishingtechnical quality checkscompliancesubmission managementregulatory processesregulatory intelligence monitoringinspection readinessaudit support

Soft Skills

attention to detailorganizational skillscommunication skillsinterpersonal skillsability to manage multiple taskscollaborative relationshipsstakeholder managementrisk identificationtransparencyadaptability