Senior Publisher/Regulatory Operations Specialist - REMOTE

Highly Competitive Salary
  1. Permanent
  2. Senior/Director & VP, Publishing & Submissions, Operations
  3. United States
Scranton, USA
Posting date: 11 Aug 2023

This vacancy has now expired. Please see similar roles below...

Proclinical is seeking a remote Senior Publisher / Regulatory Operations Specialist for a cutting-edge pharmaceutical company.

Must be eligible to work in the US.

Job Responsibilities:

  • Responsible for the preparation of documents for publishing, compilation, and QC of regulatory submissions to Regulatory Health Authorities (e.g., FDA and EMA), including but not limited to IND, BLA/NDA/MAA, IND amendments, meeting requests and briefing books
  • Knowledgeable of eCTD templates and structure of Modules (1-5)
  • Word formatting, PDF publishing and eCTD backbone compilation of regulatory submissions
  • Assures completeness and quality of submissions from the operations perspective
  • Identifies issues, suggests and implements solutions
  • Properly archives regulatory submissions
  • Knowledge of current regulations, laws and guidance, both US and ex-US
  • Responsible for interaction with team members across a number of development programs
  • Keeps track of and manages timelines
  • Interfaces with project managers, regulatory leads, and/or content authors to provide technical guidance and support in finalizing submission content
  • Promotes and demonstrates collegiality with all firm members
  • Participates in the training and development programs

Skills and Requirements:

  • Extensive knowledge of IND/BLA/eCTD and other electronic requirements and guidelines
  • A minimum of a BS in Chemistry or Life Sciences
  • Experience with DocuBridge software, minimum of 3 years is required
  • A minimum of 3 years pharmaceutical and/or medical device industry experience
  • A minimum of 3 years of regulatory affairs in FDA regulated products
  • Expert skills in MS Office, Adobe Acrobat applications, electronic/document/data management systems
  • Excellent editing and organizational skills
  • Ability to handle multiple tasks with strong attention to detail
  • Excellent interpersonal communication skills, both oral and written
  • Ability to work under strict deadlines and changing priorities

If you are having difficulty in applying or if you have any questions, please contact Funmi Gbadamosi at +(1) 617-963-0342 or

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.