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

eFQ1SnRZblRwd0lsb1dFVDJha1k0Y2l1ZEE9PQ==
  • 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

Liberty Health

TRANSPORTATION COORDINATOR - CNA/EMT - PINEHURST HEALTHCARE & REHABILITATION CENTER Job at Liberty Health

 ...concern for the elderly and disabled. ~ Must currently be registered with DFS as a Nursing Assistant or as an Emergency Medical Technician in North Carolina. ~ Must maintain a current CPR certification via the American Heart Association. ~ Ability to plan,... 

Insight Global

Administrative Assistant Job at Insight Global

 ...Assistant to join a large company in Tulsa, OK. This role involves handling incoming and outgoing mail and packages, ensuring timely delivery while maintaining accurate tracking through various mailing systems. Additionally, it includes processing print job requests,... 

Malone Workforce Solutions

Process Supervisor Job at Malone Workforce Solutions

 ...We are looking for a 2nd and 3rd Shift - Wareroom Supervisor - Processing to join the team! This a full-time, direct hire position that is 100% on-site in a manufacturing facility in Austin, IN . Wareroom Supervisors are responsible to develop, implement, and... 

Jacksonville Transportation Authority

Cybersecurity Engineer - I Job at Jacksonville Transportation Authority

 ...Brief Description of Work: The Cybersecurity Engineer - I role is responsible for monitoring the computer and network security of the...  ...confidentiality, integrity, and availability of JTA data. Provides internal audit functions to the Technology & Innovation department.... 

B. BRAUN MEDICAL (US) INC

Technical Training Program Specialist Job at B. BRAUN MEDICAL (US) INC

B. Braun Medical, Inc. Company: B. BRAUN MEDICAL (US) INC Job Posting Location: Irvine, California, United States Functional Area: Human Resources Working Model: Onsite Days of Work: Thursday, Wednesday, Tuesday, Friday, Monday Shift: 5X8 Relocation...