Regulatory Affairs Specialist II

SGS_JOB_3575

Scientific
 New Jersey
Regulatory Information Management System (RIMS)
Global Compliance
FDA Regulations
UDI (GUDID
EUDAMED
AUSUID)
eCTD
Estar
SOP Authoring
Regulatory Data Governance (Veeva Vault
Agile)
Power BI
Tableau

Contract - 12 Months Contract

Location : Princeton, NJ 08540. Experienced Regulatory Affairs professional responsible for supporting global regulatory operations, ensuring compliance, maintaining regulatory data accuracy in RIMS, and enabling timely market access across multiple jurisdictions. The role requires 5 days a week onsite presence in Princeton, NJ during normal business hours.

Job Responsibilities:

  • Utilize the Regulatory Information Management System (RIMS) to manage data accuracy, integrity, and process efficiency; perform data analysis and manage submission/document and data uploads and verification; generate RIMS extracted reports to support regulatory strategies, key performance indicators, and blocked orders, etc.
  • Develop, maintain, monitor and continuously improve regulatory global standard operating procedures (GSOPs), work instructions, and process controls to support organizational compliance.
  • Collaborate and provide cross-functional expertise and support for regulatory operations department requirements such as device establishment registrations, device listings, global unique device identification (UDI) (e.g., FDA GUDID, EUDAMED, AUSUID etc.) and electronic publishing.
  • Ensure regulatory readiness, operational efficiency, and inspection-ready documentation across multiple jurisdictions.
  • Support regulatory intelligence, UDI, publishing, and establishment registrations activities.

Skills:

  • Utilizes knowledge of all applicable laws and regulations that apply to the industry worked in and assures staff members are aware of the legal standards that apply to their work and that they are followed.
  • Reviews the processes used in their industry and establishes guidelines and standards for specific tasks.
  • Evaluates the processes in place and reviews data and documents.
  • Prior experience with authoring and executing standard operating procedures, process documentation, and automation.
  • Experience with regulatory data governance platforms and change management systems (e.g., Veeva Vault, Agile, etc.).
  • Exposure to process automation, dashboards, or analytics (Power BI, Tableau, etc.).
  • Familiarity with regulatory submission formats, including Estar, eCTD, and paper submissions.
  • Must possess and demonstrate an understanding of FDA Regulations and international regulations.

Education/Experience:

  • bachelor’s degree is required.
  • 4–6 years of experience.
  • Experienced professional who supports the development and execution of regulatory strategies with a strong focus on global compliance.

Related Jobs

Biotechnologist Associate

Scientific
 New Hampshire
12 months

Location (mandatory): Portsmouth NH Looking for a candidate with science degree and some manufacturing experience

GMP
cGMP
lab work

Manufacturing Associate - Biotech

Scientific
 California
$25-$27.50
12 Months

Location (mandatory): Vacaville CA The Manufacturing Associate is responsible for the manufacture of therapeutic proteins (API) under cGMP conditions. Level I associates are expected to execute process recipes, follow written procedures (SOPs), monitor equipment and processes, perform basic laboratory tasks, including pH, conductivity, sampling, and conduct routine sanitization tasks to maintain facility and equipment. They are expected to attain a basic understanding of cGMP compliance while training under close supervision, demonstrating aseptic technique in handling of products and materials.

GMP
Manufacturing environment
Laboratory tools

QA Documentation Specialist I

Scientific
 California
28.26
6 months

Location (mandatory): 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

Quality Control Biochemistry Associate

Scientific
 North Carolina
$42/hr on W2
06 – 12 Months Contract + (Highest possibilities of contract extension)

Small Description: The Quality Control Biochemistry Associate II is responsible for contributing to key functional, tactical, strategic and operational aspects of the large molecule testing for Biochemistry group. This includes performing in-process, release testing, method transfer, validation testing and related activities associated with this testing.

Quality Control
Biochemistry
In-Process Testing
Release Testing
Method Transfer
Validation Testing
GLP
GMP
pH Testing
Appearance Testing
Osmolality Testing
Protein Concentration Testing (UV
RI
SoloVPE)
Quality Systems
Investigations
Laboratory Systems
Written Communication
Verbal Communication

SFC/HPLC Analytical Development Scientist

Scientific
 Massachusetts
40/hr
06 Months Contract + (Highest possibilities of contract extension)

Location : Cambridge, MA 02142 (Onsite) The Analytical Development team is seeking a highly creative and self-motivated candidate to join for a 6-month contract. This role will support the development of small molecule drug substances and drug products by developing innovative analytical technologies and establishing control strategies. The position will be responsible for chromatographic method development using supercritical fluid chromatography (SFC) and requires knowledge of organic chemistry, analytical chemistry, and experience working in a laboratory environment. Experience with analytical techniques such as UV, HPLC/UPLC, and LCMS is required.

Supercritical Fluid Chromatography (SFC)
HPLC
UPLC/UHPLC
LCMS
UV Detection
Analytical Method Development
Analytical Chemistry
Organic Chemistry
Pharmaceutical Analysis
Data Analysis
Technical Reporting

Environmental Monitoring Associate

Scientific
 North Carolina
06 Months Contract + (Highest possibilities of contract extension)

Location: Research Triangle Park, NC 27709 (Onsite) Responsible for performing testing and sampling of bulk gases, monitoring utility parameters, inspecting raw materials, and collaborating with cross-functional teams including Microbiology and Manufacturing to ensure quality and compliance in research and production activities.

TOC testing
Conductivity testing
Nitrate testing
Gas sampling (viable and non-viable particulates)
THC and Moisture sampling
Raw material inspection
Documentation review
Utility Monitoring
Routine Cleaning
Validation Samples

Dispensing Technician

Scientific
 New Hampshire
$34.36/hr
12 Months

Location : Portsmouth NH 03801. The Dispensing Technician Level 1 supports the manufacturing of therapeutic proteins (API) by dispensing raw materials, including liquids, powders, acids, and bases, under cGMP conditions. This night-shift role requires attention to detail, adherence to cGMP and SOPs, and active participation in safety and quality processes within a controlled Class C environment.

Dispensing
SOP
Sanitation
documentation

Biotechnologist Associate

Scientific
 New Hampshire
12 months

Location (mandatory): Portsmouth NH Looking for a candidate with science degree and some manufacturing experience

GMP
cGMP
lab work

QC Analyst III

Scientific
 New Hampshire
06 Months

Location (mandatory): Portsmouth NH The Quality Microbial Control Analyst V will be part of the Quality Microbial Control team, supporting the production of in-process and final product drug lots for customers. The role involves quality testing for customer stability studies, providing timely, high-quality results to meet Manufacturing demands. The Analyst will apply job skills, follow company policies, and contribute to projects and tasks of increasing scope. The role also provides technical support within the department and across the facility, potentially acting as a subject matter expert (SME) and supporting the supervisor in their absence.

Microbial Control Testing
Deviations
CAPA
Change Control
Test Method
TrackWise
LIMS
logo

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


© 2026 All rights reserved.
logologologologo