Regulatory Operations, Submission Management

SGS_JOB_1037

Scientific
Remote
eCTD Submission Management
Publishing
QC checks
Health Authority Guidelines/Regulations

Contract - 08 Months+

Performs eCTD submission management across Biogen's product portfolio to Health Authorities for global development and lifecycle management submissions. The Regulatory Ops. Manager is responsible for the coordination of all publishing deliverables, in line with the strategic direction of their assigned programs/products. Oversee outsourced publishing deliverables on a day-to-day basis to ensure successful execution of operational activities for assigned products.

Job Responsibilities:

  • Acts as the primary point of contact for regulatory functions as appropriate in the product’s lifecycle.
  • The Regulatory Ops. Manager ensures submission deliverables are incorporated and visible to all stakeholders.
  • Ensure hand offs and deliverables from authoring community are on time and in line with the submission standards and expectations of quality.
  • Drives deliverable timelines with RSM (RA Regulatory Submission Manager) and authoring community and sets appropriate standards and expectations of quality.
  • Responsible for electronic submissions and documents meeting regulatory agency and Biogen submission standards and technical requirements.
  • Quality checks on electronic common technical (eCTD) components, final submissions, hyperlinks and bookmarks, and ensures submissions adhere to local health authority guidelines.
  • Demonstrates expert knowledge of submission or technology-related Health authority guidelines/regulations.
  • Competent in the use of electronic document management and submissions publishing tools

Skills:

  • eCTD Submission Management
  • Publishing
  • QC checks
  • Health Authority Guidelines/Regulations

Education/Experience:

  • Minimum Education qualification required. :  Bachelor's
  • Years of experience required: 5 plus years of experience

Related Jobs

Lab Technician

Scientific
 Ohio
03 months

Location: Cincinnati, OH (Onsite) The Lab Technician performs a variety of chemical, biological, and physical tests required for research, development or quality control. This position compiles data for reports and assists in special studies in the laboratory and in the field.

Chemical and biological tests for research
development and quality control.

Operations Test Associate

Scientific
 California
$26-$30
06 Months

Location : San Diego CA The Operations Test Associate candidate will be responsible for performing QC release testing and analysis of raw materials, in-process, and finished goods for the Molecular Diagnostics Division. The candidate will be responsible for understanding and executing testing on multiple assay platforms in a cGMP environment to ensure timely release of products.

Lab Experience
GMP/GLP
ERP
LIMS
or QSR

QA Documentation Specialist I

Scientific
 California
$28.26
6 Months

Location : Vacaville CA We are seeking a highly motivated and experienced Quality Systems Support Specialist to join our team in Vacaville, CA. In this role, you will provide essential support to the Quality System Management process with document control and PQS integration, ensuring compliance with cGMP and global requirements.

Veeva
QMS
DMS

QC Analyst III

Scientific
 New Hampshire
12 Months + (Possibilities of Contract Extension)

Location (mandatory): Portsmouth NH • We are seeking a QC Analyst III will act as a team member of the Quality Control department to support production by contributing to the completion of the technical transfer activities. Also participate in quality testing for customer in-process, final product testing and stability studies when needed.

Quality control
A280
CE-SDS
icIEF
ELISA
SoloVPE
qPCR

Process Engineer I

Scientific
 Arizona
12 Months (possible extension)

Location - Marana, AZ The global sub-chapter Production Engineering - Change Services is part of the global Engineering Chapter responsible for cost efficient, reliable and lean Change Control Management (ECRs). The scope of this team is mainly on Product Care topics for established products and introduction of new products from pilot phase to commercial production. The sub-chapter brings in technical expertise to deliver successful material, system, process and product changes.

Electro-mechanical
Fluidic/Pneumatic Systems
NPI (New Product Introduction
Change Management
Root Cause Analysis

Drug Safety Specialist - GPV

Scientific
Remote
12 Months

The Data Assurance Associate (GPV) plays a vital role in ensuring the accuracy, compliance, and quality of case processing activities within Pharmacovigilance. This role involves active communication with internal teams, external partners, and vendors to address case-related queries, oversee case corrections, and support training initiatives. The associate will contribute to maintaining the highest standards in pharmacovigilance operations while driving process improvements and compliance with global regulatory requirements.

Pharmacovigilance
PV Regulatory Requirements
ICSR Processing
ARGUS Safety Database
Experience with Word
Excel
PowerPoint
Microsoft Teams and SharePoint
Case Processing.

QC Specialist II

Scientific
 California
$33.38
06 months

Location : Vacaville CA Under moderate supervision, QC Specialist is expected to support planning, managing, and executing projects related to the product portfolio for Vacaville Quality Control. These projects include analytical transfers, control system updates, regulatory filings and other activities associated with the life-cycle of a product.

Quality control

Validation Engineer II

Scientific
 California
$37.38 - $62.20 on W2
6 Months

Location - Vacaville California Responsible for support and execution of QC laboratory equipment qualification activities while in full compliance with current cGMP regulations and Roche/Genentech corporate principals, quality policies, standards and core values. Maintains company’s right to operate, supply to patients, and cost effectiveness by actively participating in continuous improvement projects

Validation
GMP
Equipment

Office Coordinator

Scientific
 Florida
06+ Months

Location : Davie, FL 33314 Shift: US time zone 8 hours/day. Willingness and passion to keep things organized, digital literate organization skills and digital literacy should be visible and demonstrate

Office Coordinator
visual signage and labeling to support 5S and workplace organization
Power BI
logo

At SGS Consulting, we go beyond resume-job matches, creating meaningful connections and pathways for individuals to thrive in defining careers.


2025. All right reserved.
logologologologo