Manager, Regulatory Operations

Beacon Hill - Job Details
< Back to Search Results

Manager, Regulatory Operations

Newton, Massachusetts

|

Full Time Temp to Hire

|

NA

Newton, Massachusetts

Full Time Temp to Hire

NA

November 16, 2022

|

Job ID: P1315204BOSJB_1668626754

November 16, 2022

Job ID: P1315204BOSJB_1668626754

Job Summary

Job Id: P1315204BOSJB_1668626754 Apply Now

Our client is a clinical-stage pharmaceutical company focused on the discovery and development of novel first in-class drugs directed against nuclear transport targets for the treatment of cancer and other major diseases.

RESPONSIBILITIES:

  • Format MS Word submission components in accordance with regulatory requirements
  • Provide eCTD/CTD publishing services including, rendering, bookmarking, hyperlinking, compilation, table of contents creation and QC regulatory submissions to Regulatory agencies
  • Create, update and maintain submission templates that meet global regulatory requirements
  • Coordinate with Regulatory Affairs to establish submission timelines, obtain on-time deliverables and ensure regulatory compliance for planned submissions
  • Maintain regulatory submissions filing and Health Authority correspondence logs with tracking system
  • Write or review internal work instructions and standard operating procedures (SOPs) pertaining to submission preparation (electronic or paper)
  • Understand current global regulatory submission standards, software validation concepts, and publishing best practices
  • Evaluation and implementation of internal procedures related to document control, folder structure and electronic archiving
  • Manage configuration, correspondence, and agency queries in Veeva RIMs.
  • QC and file regulatory submission documents in eTMF

QUALIFICATIONS:

  • 4-5+ years of experience with regulatory submissions, compiling eCTD submissions and Document level publishing, or equivalent combination of education and experience
  • Must be able and willing to work in a high-visibility, fast-paced environment. Must be flexible, detail-oriented, and possess good analytical and problem-solving skills
  • Monitors global health authority regulations, guidelines, and specifications including FDA, EMA, MHRA, Health Canada, and ICH for regulatory submissions to ensure compliance
  • Experienced in MS Word, Excel, PowerPoint, and Adobe Acrobat, Veeva Vault RIMs
  • Experience with electronic document management software and publishing packages
P1315204BOSJB_1668626754

Apply Now

Apply Now



About Beacon Hill

Beacon Hill is an Equal Opportunity Employer that values the strength diversity brings to the workplace. Individuals with Disabilities and Protected Veterans are encouraged to apply.

Founded by industry leaders to set a new standard in search, career placement and flexible staffing, we deliver coordinated staffing solutions with unparalleled service, a commitment to project completion and success and a passion for innovation, creativity and continuous improvement.

Our niche brands offer a complete suite of staffing services to emerging growth companies and the Fortune 500 across market sectors, career specialties/disciplines and industries. Over time, office locations, specialty practice areas and service offerings will be added to address ever changing constituent needs.

We look forward to working with you.

Beacon Hill. Employing the Future™