Regulatory Publishing Manager Job at Russell Tobin, San Diego, CA

ZGxlUHVZanM1N2hxNDg3R3BEMkgxV2RtdEE9PQ==
  • Russell Tobin
  • San Diego, CA

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.

APPLY NOW!

Job Tags

Similar Jobs

Scientific Search

Firmware Engineer Job at Scientific Search

 ...electrical engineering, Computer Science, or related field. Experience: no previous working experience required. Strong...  ...package, plus participation in a company-wide bonus plan. For immediate consideration and faster response, please forward current resume... 

BEPC Inc. - Business Excellence Professional Consulting

Process Development Engineer Job at BEPC Inc. - Business Excellence Professional Consulting

 ...efficiency. Apply Lean Six Sigma methodologies and maintain up-to-date process risk documentation (e.g., pFMEA). Collaborate across the Roche network to share and implement best practices. Quality Mindset: Ensure compliance with Quality System requirements through... 

Kilpatrick Investments

Hotel General Manager Job at Kilpatrick Investments

 ...We are looking for a General Manager candidates that are savvy, curious and cares enough to offer guests everything they need and nothing...  ...with IHG, Marriott and Hilton brand franchises, operating with hotels in both north and south Louisiana. We arelooking for a hotel... 

Skills for Chicagoland's Future

Phlebotomist Job at Skills for Chicagoland's Future

 ...collaboration Additional InformationLocations include Swedish Hospital (Foster & California), Evanston Hospital, Skokie Hospital Overnight, weekend, and holiday shift differentials may be available LocationChicagoBenefitsDental;Employee Assistance;Life Insurance;Long Term... 

V-Soft Consulting Group, Inc.

Janitor/Custodial Worker Job at V-Soft Consulting Group, Inc.

 ...the health and wellness of our visually impaired student population by ensuring that all facilities are maintained to the highest standard of cleanliness and safety. Minimum Qualification: High school diploma or GED equivalent; no previous experience required....