Job Description

The Science team at Russell Tobin is supporting Leading Pharmaceutical Company to hire "Regulatory Publishing Manager"

Key Responsibilities:

• Utilize IQVIA RIM Smart and Veeva Vault RIM to publish eCTD submissions and reports in accordance with FDA, EMA, and ICH guidelines.
• Perform QC of published eCTD submissions and work with team members to resolve technical or formatting issues.
• Format authored documents consistently; ensure submission-readiness of PDFs by editing bookmarks, hyperlinks, and other key elements.
• Support document authors and contributors by advising on document management system usage and submission requirements.
• Deliver Regulatory Operations kickoff presentations for clinical study reports and manage tracking of study appendices with SMEs and authors.
• Coordinate with IT, QA, and system business owners to support the implementation, validation, and maintenance of regulatory systems.
• Participate in the configuration and ongoing enhancement of regulatory information management and publishing systems.

Required Skills & Qualifications:

• Minimum of 5 years of experience in Regulatory Operations, with hands-on experience in eCTD publishing .
• In-depth knowledge of eCTD guidance (ICH, FDA, EMA) and regulatory submission requirements.
• Experience with Veeva Vault RIM , IQVIA RIM Smart , and tools like Adobe Acrobat , DXC Toolbox , and formatting templates.
• Familiarity with computer system validation (CSV) and change control procedures.
• Strong ability to collaborate across Regulatory Affairs, Medical Writing, QA, and IT functions.
• Excellent verbal and written communication skills, especially related to regulatory submissions and systems.

Education:

• Bachelor’s degree in Life Sciences , Information Technology , Business Administration , or a related discipline.

Pay range: $50-$55/hr. on W2

Must be authorized to work in the United States.

Russell Tobin offers eligible employee’s comprehensive healthcare coverage (medical, dental, and vision plans), supplemental coverage (accident insurance, critical illness insurance and hospital indemnity), a 401(k)-retirement savings, life & disability insurance, an employee assistance program, identity theft protection, legal support, auto and home insurance, pet insurance, and employee discounts with some preferred vendors.

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