Senior Associate Consultant, Regulatory Publisher

R&D Operations · Malvern, Pennsylvania
Department R&D Operations
Employment Type Full-Time
Minimum Experience Mid-level

Red Nucleus is hiring a Senior Associate Consultant, Regulatory Publisher to support our Global R&D Operations team! This position can be based out of any Red Nucleus office, or full-time remote.



About Red Nucleus

Red Nucleus is the leading provider of strategic learning, performance, and process solutions for the life sciences industry. Our team is composed of more than 450 full-time employees whose commitment to creativity, quality, and on-time delivery is unrivaled in our space. At Red Nucleus, we work in an environment that fosters trust, self-expression, and the ability to excel in our careers. We are proud to have been recognized as one of the “Best Places to Work in PA” for all 4 years that we have been headquartered in PA.


Red Nucleus R&D Operations team is comprised of a dynamic team of management consultants and R&D subject matter experts specializing in cross-functional R&D delivery stemming from activities led by Regulatory Affairs.



Job Summary

Red Nucleus-R&D is seeking motivated individuals to join a team of consultants committed to delivering quality results to their clients and their businesses. Consultants and Managers will be work with Red Nucleus Partners and other team members to help organizations solve issues, create value, maximize growth and improve business performance.



Responsibilities

You will be working alongside partners, subject matter experts and industry specialists to ensure that all client deliverables meet customer expectations. You will be expected to actively contribute to business transformation, process optimizations and system improvements. The role will require you to represent Red Nucleus in addressing the client’s business requirements and needs including:

  • Provide global expertise on requirements for electronic document management, submission planning and compilation, publishing, and management of approval information
  • Manage regional submissions and support global submissions as a Lead Publisher
  • Proactively communicate requirements and issues to be considered to the Submission Team, and contribute to achieving realistic timelines
  • Proactively collect necessary information from the Submission Team, and plan all submission management related activities
  • Proactively communicate with clients on submission requirements including eCTD
  • Liaise with agency experts on electronic submission requirement
  • Perform quality checking of documents and regulatory submissions to ensure compliance with submission-ready standards
  • Compile and publish regulatory submissions in accordance with current standards and processes using agreed upon tools
  • Analyze submissions and track and record life-cycle information in accordance with standards
  • Perform complex searches on submission life-cycle information, as required
  • Keep updated on regulatory authorities requirements on technical/format aspects of submissions worldwide and ensure their incorporation into RN standards
  • Participate on or lead special project teams (e.g., skill work, standards).



Education, Experience, Training, and Knowledge:

  • 5-8 years of experience in the pharmaceutical industry with a focus in Regulatory Operations
  • 5-8 years of experience publishing, submitting and managing documents and submissions in a document repository
  • Experience assisting in publishing or project managing major (NDA, MAA, etc.) submissions
  • Understanding of drug development documents
  • At least 5 years of experience with publishing
  • At least 3years of experience with regulatory global registration management information and systems
  • Experience assisting with the implementation of a regulatory technology such as, Documentum, First Docs, Insight Manager, Insight Publisher, etc. (Preferred)
  • Experience assisting in the migration of documents and submissions from one regulatory system technology to another (Preferred)
  • Proficient in Microsoft Suite software including Excel, Word, PowerPoint, Visio
  • Bachelors degree preferred


Red Nucleus is an equal opportunity employer.



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  • Location
    Malvern, Pennsylvania
  • Department
    R&D Operations
  • Employment Type
    Full-Time
  • Minimum Experience
    Mid-level