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Regulatory Operations Jobs in Delaware (NOW HIRING)

United Cocoa Processor

Be Seen First

Regulatory Specialist

Newark, DE · On-site

$65K - $75K/yr

● Verify that all regulatory policies and procedures have been documented, implemented, and ... Analyze operational problems, identifies solutions, and implement corrective actions. ● ...

AstraZeneca

Manager, REMS

Wilmington, DE · On-site

Are you ready to turn regulatory rigor into real patient impact by safeguarding access to transformative medicines? As Manager REMS, you will lead the operational execution of complex Risk Evaluation ...

AstraZeneca

Manager, REMS

Wilmington, DE · On-site

Are you ready to turn regulatory rigor into real patient impact by safeguarding access to transformative medicines? As Manager REMS, you will lead the operational execution of complex Risk Evaluation ...

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How much do regulatory operations jobs pay per hour?

As of Jul 26, 2026, the average hourly pay for regulatory operations in Delaware is $26.27, according to ZipRecruiter salary data. Most workers in this role earn between $17.79 and $30.34 per hour, depending on experience, location, and employer.

What do regulatory operations do?

Regulatory operations professionals manage the processes and systems involved in preparing, submitting, and maintaining regulatory documents for product approvals and compliance. They ensure that regulatory submissions meet legal requirements, often using specialized software and adhering to strict deadlines. Their work supports the successful approval and ongoing compliance of products in regulated industries such as pharmaceuticals and medical devices.

What are common day-to-day responsibilities for professionals in Regulatory Operations?

Regulatory Operations professionals are primarily responsible for preparing, formatting, and submitting regulatory documents to health authorities, ensuring they meet stringent compliance standards. They coordinate with cross-functional teams—such as clinical, quality, and legal departments—to gather and verify required information. Daily tasks often include managing document workflows, maintaining regulatory databases, and tracking submission timelines. This role requires close attention to regulatory updates and an ability to quickly adapt processes in response to changing requirements.

How to get into regulatory operations?

To enter regulatory operations, candidates typically need a bachelor's degree in life sciences, healthcare, or a related field. Gaining experience with regulatory submissions, understanding compliance standards, and developing skills in document management and regulatory software can improve prospects. Certifications such as RAC (Regulatory Affairs Certification) can also enhance qualifications.

What are the key skills and qualifications needed to thrive in the Regulatory Operations position, and why are they important?

To excel in Regulatory Operations, candidates should have a strong understanding of regulatory guidelines, documentation processes, and compliance standards—often supported by a degree in life sciences, pharmacy, or a related field. Familiarity with electronic document management systems (EDMS), submission publishing tools, and possibly certifications such as Regulatory Affairs Certification (RAC) are commonly expected. Excellent attention to detail, project management, and effective communication skills enable individuals to coordinate across teams and ensure timely submissions. These competencies are critical for maintaining compliance, minimizing risk, and supporting the efficient approval of products in highly regulated industries.

What is the highest paying job in regulatory affairs?

The highest paying roles in regulatory affairs are typically senior executive positions such as Vice President or Director of Regulatory Affairs, which can offer salaries exceeding $150,000 annually. These roles often require extensive experience, leadership skills, and knowledge of regulatory compliance, often supported by advanced certifications like RAC (Regulatory Affairs Certification).

What is a Regulatory Operations job?

A Regulatory Operations job involves managing the submission and compliance processes required for regulatory approval of products, typically in industries like pharmaceuticals, biotechnology, and medical devices. Responsibilities include formatting and submitting regulatory documents, ensuring compliance with global regulations, and maintaining submission lifecycle management. This role often requires collaboration with cross-functional teams, expertise in regulatory guidelines, and proficiency in regulatory submission systems such as eCTD.

Is regulatory a good career?

Regulatory operations is a vital role in industries like pharmaceuticals, healthcare, and finance, ensuring compliance with laws and standards. It offers opportunities for career growth, requires attention to detail, and often involves working with regulatory agencies and documentation systems. The field can be stable and rewarding for those interested in legal and compliance processes.
What are the most commonly searched types of Regulatory Operations jobs in Delaware? The most popular types of Regulatory Operations jobs in Delaware are:
What are popular job titles related to Regulatory Operations jobs in Delaware? For Regulatory Operations jobs in Delaware, the most frequently searched job titles are:
What job categories do people searching Regulatory Operations jobs in Delaware look for? The top searched job categories for Regulatory Operations jobs in Delaware are:
Regulatory Operations jobs near you
Infographic showing various Regulatory Operations job openings in Delaware as of July 2026, with employment types broken down into 86% Full Time, 12% Part Time, 1% Temporary, and 1% Contract. Highlights an 95% Physical, 2% Hybrid, and 3% Remote job distribution, with an average salary of $54,635 per year, or $26.3 per hour.
Senior Manager, Regulatory Operations

Senior Manager, Regulatory Operations

Incyte Corporation

Wilmington, DE • On-site

Full-time

Posted 20 days ago

Job description

Overview
A global biopharmaceutical company on a mission to Solve On, Incyte follows science to find solutions for patients with unmet medical needs. Through the discovery, development, and commercialization of proprietary therapeutics, Incyte has established a portfolio of first-in-class medicines for patients and a strong pipeline of products in Hematology, Oncology and Inflammation and Autoimmunity
Headquartered in Wilmington, Delaware, Incyte has operations in North America, Europe, and Asia.
The job is based in Wilmington Delaware, US. (Minimum 3 days per week in the office. Local candidates or those willing to relocate only).
Job Summary (Primary function)
The Senior Manager, Regulatory Operations, is responsible for managing and maintaining existing development and marketing authorization dossiers, managing RIM objects and compiling submissions in compliance with ICH specifications and Health Authority regulations globally. The Sr Manager will coordinate with functional leads in various disciplines to ensure compliant documents, maintain regulatory information and the physical and electronic regulatory archives, mentor on eCTD requirements and other duties and/or special projects as assigned or required.
Essential Functions of the Job (Key responsibilities)
  • Responsible for the timely planning, compiling, publishing, review and delivery of compliant regulatory submissions to Regulatory Health Authorities.
  • Ensures documents and RIM objects comply with submission ready standards and guidelines and provides guidance with respect to requirements.
  • Maintains and archives all regulatory correspondence in appropriate systems.
  • Liaises with vendors for submission support, as needed.
  • Participates in validation or verification testing of templates, electronic document management system, information management and document/submission publishing related tools.
  • Maintains tracking tools and systems for regulatory information, including submission content plans.
  • Support other areas of the company (eg., Business Development) concerning regulatory documentation, as needed.
  • Maintains current working instructions for regulatory-related systems (e.g. publishing software, RIM and EDMS.
  • Mentors team members on submission processes and requirements and may manage contract Regulatory Operations personnel.
  • Contribute positively to a strong culture of business integrity and ethics.
  • Act within compliance and legal requirements as well as within company guidelines.
  • Coordinate the preparation and review of documents for regulatory submissions (e.g. cover letters, forms, DSURs, safety reports, etc.).
  • Participates in the preparation of dossiers containing manufacturing, preclinical, and clinical data.
  • Provides guidance to authors for clear document and data presentation and location in order to optimize submission navigation as well as the regulatory review and approval process.

Qualifications (Minimal acceptable level of education, work experience, and competency)
  • Bachelor's degree in a relevant field (e.g., science, technology, health, or business management) or equivalent experience. Candidates with diverse educational backgrounds are encouraged to apply.
  • Minimum of relevant experience in a regulatory affairs environment with document management systems, electronic publishing systems, and electronic submissions, including eCTD, and direct submission to global Health Authorities. Candidates with equivalent skills and knowledge are encouraged to apply.
  • Experience in drug development and familiarity with global regulatory submission content and formats.
  • Experience with SPL, advertising and promotional submissions, device submissions, and combination products submissions is valued.
  • Strong technical knowledge and proficiency in publishing and related computer software, including advanced word processing and design tools such as MS Word, Adobe, and Adobe plug-ins.
  • Strong organizational, communication, and writing skills are essential.
  • Ability to manage multiple priorities and projects, with support for diverse working styles and needs.
  • Strong attention to detail and quality.

Disclaimer: The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications. Management reserves the right to change or modify such duties as required.
Incyte Corporation is committed to creating a diverse environment and is proud to be an equal opportunity employer.
We Respect Your Privacy
Learn more at: http://www.incyte.com/privacy-policy
The Incyte hiring organization processes your personal data to manage your job application in order to enter into an employment relationship with you if you are the successful candidate.
During the process, you may be asked to respond to questions that will screen out your application if you do not meet certain objective criteria required by the job. You can learn more about this process here.
You may have the right to access, delete, restrict, edit, move, or object to the use of your personal data. You may also have a right to report concerns to the authority responsible for data privacy in the country where the position is based or where you live or work.
You can learn more about Incyte's data protection practices here. By accessing this link you can learn about the types of personal data we collect, how we use it, whether collection and processing is optional, sources of the personal data we process, how it is shared, where it is stored or transferred to, how long we keep it, and contact information for Incyte, Incyte's data protection officer, and your supervisory authority (if applicable).
Please contact privacy@incyte.com if you have any questions or concerns or would like to exercise your rights.
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