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

VzZscG9lRkZaVW9XeHhkSjVlSlNlcW1mTFE9PQ==
  • 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

StretchLab South Sarasota

Fitness Professional/Personal Trainer/Dance/Yoga Instructor Job at StretchLab South Sarasota

StretchLab is seeking personal trainers, massage therapists, physical therapists, and dance/yoga/Pilates Instructors to join our team. This is an amazing opportunity to gain experience in a new modality that is taking the fitness industry by storm. StretchLab is the ...

LVI Associates

Project Manager- Athens Job at LVI Associates

 ...We are seeking a motivated and experienced Project Manager with a background in civil/site development to join our growing team in Atlanta, GA . The ideal candidate will have a strong technical foundation in civil engineering, proven project management experience... 

POSCO AAPC

Production Coordinator (Shipping and Receiving Manager) Job at POSCO AAPC

 ...JOB SUMMARY Shipping and Receiving Manager will operate both remote overhead crane and Forklift to safely and efficiently load/unload coils/Sheets from trucks and/or railcars and distribute the material to its designated area. ESSENTIAL FUNCTIONS*: Reasonable... 

Potawatomi Casino Hotel

Employee Relations Specialist Job at Potawatomi Casino Hotel

 ...contribute HR value to the business? As a Team Member Relations Specialist, you will provide guidance and assistance to team members at...  ...counting using whole numbers and fractions. # The ability to read and interpret written instructions and diagrams. # The ability... 

The Mice Groups, Inc.

Process Technician Job at The Mice Groups, Inc.

 ...Our Client is seeking a Process Technician for a 2-year Contract position in Tualatin, OR. This position is 100% onsite and shifts are 5:00pm 5:00am Wednesday Friday with alternating Saturdays once training is complete. This position pays up to $30-37/hr. W2. Responsibilities...