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Regulatory Affairs Operations Associate Jobs (NOW HIRING)

Abbott

Regulatory Affairs Specialist

Pleasanton, CA · On-site

The Opportunity This Regulatory Affairs Specialist will work out of our Pleasanton, CA location in ... Regulatory Operations DIVISION: HF Heart Failure LOCATION: United States > Pleasanton : 6101 ...

Hoya

Director, Regulatory Affairs, Americas

Lewisville, TX · On-site

$138K - $182K/yr

It also provides the opportunity to contribute to stronger and more consistent global Regulatory Affairs operations, with direct exposure to senior stakeholders and cross-functional teams. For the ...

Stark Pharma Solutions Inc

IL · On-site

Lake County, IL Duration: Long Term Position Overview We are seeking a Regulatory Affairs Associate I to support regulatory operations, data management, submission tracking, and compliance activities ...

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Infographic showing various Regulatory Affairs Operations Associate job openings in the United States as of August 2026, with employment types broken down into 88% Full Time, 11% Part Time, and 1% Contract. Highlights an 94% Physical, 2% Hybrid, and 4% Remote job distribution, with an average salary of $82,307 per year, or $39.6 per hour.

Regulatory Affairs Specialist

Cambridge, MA

Artech Information System LLC
Recruiting and Staffing Services • 10K+ employees
Learn more about Artech Information System LLCexternal

Contractor

Re-posted 28 days ago

Key responsibilities

  • Support the planning, development, and publishing of regulatory submissions in coordination with Global Regulatory Leads.

  • Control submission component receipt and workflow completion to ensure high-quality final submissions.

  • Dispatch submissions through the FDA Gateway and ensure adherence to internal and external standards throughout the submission process.

Job description

Company Description

Artech is the 10th Largest IT Staffing Company in the US, according to Staffing Industry Analysts' 2012 annual report. Artech provides technical expertise to fill gaps in clients' immediate skill-sets availability, deliver emerging technology skill-sets, refresh existing skill base, allow for flexibility in project planning and execution phases, and provide budgeting/financial flexibility by offering contingent labor as a variable cost.

Job Description

The Regulatory Affairs Operations (RA Ops) submission group is organized to provide submission development support to project teams and the regulatory community. The focus of this position will be to publish, submit and maintain regulatory filings in coordination with Global Regulatory Leads. The role works to tight, business-critical deadlines within a highly regulated environment. 

She/he also ensures that compliance standards are met for receipt and delivery of information to and from external consultants and health authorities.

Expert in publishing capabilities of all modules with a competency in the component locations within the eCTD backbone structure.

Support Global Regulatory Leads in the planning, development, and publishing of submissions.

Control submission component receipt and workflow completion to ensure a high quality final submission. Ensure that issues are identified at an early date and actively contribute to issue resolution before filing dates are impacted.

Coordinate publishing tasks associated with assigned submissions, including peer review of submissions generated by other publishers.

Ability to contribute to brainstorming and troubleshooting of technical issues that impact validation requirements for submission dispatch.

Dispatch submissions through the FDA Gateway

Ensure adherence to internal and external standards including Standard Operating Procedures, Guidance Documents, and Policies throughout the lifecycle of the application.

Archive submissions both electronic and paper.

Skills: 

Proficient in use of MS Office, Adobe Professional, Adobe Add-ins, Publishing Software (sCubed and/or eCTD Manager), Validation Tools and Document Management Systems.

Demonstrate ability to function autonomously in a matrix environment.

Knowledgeable in appropriate ICH and FDA regulations pertaining to regulatory and technical requirements for electronic submissions.

Must be detail oriented and articulate with strong analytical, decision-making, and interpersonal 

Demonstrate regulatory knowledge and awareness, technical competence, sound judgment, and a professional demeanor.

Demonstrate flexibility in dealing with change and diversity.

Ability to multi-task in a fast paced environment.

All candidates should have an understanding of the concepts around regulatory affairs and significant knowledge of submissions processes.

Proficient in formatting Word documents prior to publishing and electronic navigation for Adobe documents.

Education:

At least a bachelor s degree, or equivalent, in regulatory affairs, the sciences, or related areas of study, and relevant experience. Four years submission publishing experience.


Additional Information

Best Regards,

Anuj Mehta

973-967-3402


Artech logo

About Artech

Sourced by ZipRecruiter

Artech is a leading IT staffing and consulting company based in Morristown, NJ, US. Since its foundation in 1992, Artech has mastered in complementing human expertise with technology and business acumen to produce world-class staffing solutions. The company caters to diverse industry sectors, including financial services, healthcare, telecommunication, energy and utilities, supply chain, and retail. It provides IT consulting, project management, professional and staff augmentation, and managed staffing services. Artech's mission is to provide exceptional IT staffing services to its clients by comprehending their business needs and then crafting a customized staffing strategy. Its notable achievement includes being recognized as one of the largest IT staffing companies in the U.S, according to Staffing Industry Analysts (SIA).

Industry

Recruiting and staffing services

Company size

10,000+ Employees

Headquarters location

Morristown, NJ, US

Year founded

1992

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