Red Nucleus

Associate Consultant, Regulatory Operations

Red Nucleus

full-time

Posted on:

Location Type: Remote

Location: United States

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About the role

  • 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
  • Proactively communicates requirements and issues to be considered to the Submission Team, and contribute to achieving realistic timelines
  • Proactively collect necessary information from the Submission Team
  • 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 special project teams (e.g., skill work, standards).

Requirements

  • Bachelor’s degree in Life Sciences, Business, or related field required
  • 3-5 years of experience in management consulting, life sciences strategy roles, or a relevant field
  • Strong analytical and problem-solving capabilities
  • Rigorous attention to detail and accuracy
  • Self-starter and driven
  • Ability to multi-task with superior organization skills
  • Strong ability to work independently as well as be an integral part of a team
  • Dependable and flexible
  • Excellent written, verbal communication, and time management skills
  • Proficient in Microsoft Suite software including Project, Excel, Word, PowerPoint, Visio
  • Ability to work in a global environment with an understanding of cultural differences and work practices
Benefits
  • Health insurance
  • Paid time off
  • Flexible work arrangements
  • Professional development opportunities

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard skills
document managementsubmission planningregulatory submissionsquality checkingdata analysislife-cycle information tracking
Soft skills
analytical skillsproblem-solvingattention to detailself-starterorganizational skillsteamworkdependabilityflexibilitycommunication skillstime management