Regulatory Operations Specialist

Role Summary

Regulatory Operations Specialist/Senior Specialist within the Regulatory Affairs team in Germantown, Maryland. Responsible for production, compilation, and distribution of publish-ready documents for regulatory submissions, publishing and submitting regulatory submissions, and regulatory document management using EDMS (Veeva Vault) to provide internal access to submissions and communications.

Responsibilities

• Responsible for the completeness and quality of regulatory submissions from the operations perspective; collaborate with internal and external teams to support timely submissions to regulatory authorities.
• Publish and submit regulatory submissions to competent authorities.
• Manage document preparation, including formatting, approval, archiving, and tracking through the Veeva Vault RIM suite.
• Maintain, archive, and track regulatory submission documentation, including health authority correspondence, to ensure regulatory compliance.
• Format, edit, review, and generate publish-ready PDFs of submission documents per standardized templates and Regulatory Style Guide.
• Perform document quality control checks for others in the department and suggest/implement solutions under guidance.
• Participate in Regulatory Operations process improvement and system initiatives.
• Provide support for Regulatory Systems Releases via the change control process.

Qualifications

• Two (2)+ years in pharma/biopharma/CRO regulatory, with at least one (1) year in Regulatory operations/publishing/submissions/eCTD experience.
• Associate‚Äôs degree in life science, regulatory science, or related field.
• Strong knowledge of eCTD requirements, ICH guidelines, and Competent Authorities guidance for electronic submissions.
• Proficiency in MS Office; familiarity with MS Project preferred.
• Experience publishing eCTD submissions; experience with Veeva Vault RIM and Lorenz dB publishing is highly desirable.
• Experience with drugs/biologics therapy is preferred.
• Knowledge/experience managing electronic regulatory documents using an EDMS is required.
• Experience and knowledge of User Acceptance Testing is preferred.

Skills

• Intermediate to advanced Microsoft Word, Adobe Acrobat Pro DC, StartingPoint Templates, eCTD publishing, and EDMS such as Veeva Vault.
• Strong organization and time management; ability to manage multiple projects with attention to detail.
• Clear written and verbal communication; ability to coordinate with multiple stakeholders.
• Ethical standards and trustworthiness; ability to align with company mission and values.

Education

• Associate‚Äôs degree in life science, regulatory science, or related field.

Additional Requirements

• None listed beyond above qualifications.