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Regulatory Operations Jobs (NOW HIRING)

Ardelyx

Regulatory Systems Manager

Newark, CA · On-site

$117K - $143K/yr

The Regulatory Systems Manager is responsible for the administration, optimization, and day-to-day management of regulatory systems that support global regulatory operations. This role will ensure ...

Ardelyx

Regulatory Systems Manager

Newark, CA

$117K - $143K/yr

The Regulatory Systems Manager is responsible for the administration, optimization, and day-to-day management of regulatory systems that support global regulatory operations. This role will ensure ...

Ardelyx

Regulatory Systems Manager

Newark, CA

$117K - $143K/yr

The Regulatory Systems Manager is responsible for the administration, optimization, and day-to-day management of regulatory systems that support global regulatory operations. This role will ensure ...

Vibrant Ingredients

Regulatory Manager

Cranbury, NJ

Regulatory Operations & ComplianceManage regulatory oversight for assigned portfolios, ensuring compliance with applicable U.S. and international food & flavor regulations (FDA, FEMA, EFSA, CFIA ...

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How much do regulatory operations jobs pay per hour?

As of Jun 29, 2026, the average hourly pay for regulatory operations in the United States is $26.24, according to ZipRecruiter salary data. Most workers in this role earn between $17.79 and $30.29 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 and often use specialized software and industry knowledge to support product lifecycle management.

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.

What jobs pay 500,000 a year in the US?

In the US, high-paying roles such as senior executives, investment bankers, specialized surgeons, and certain technology executives can earn $500,000 or more annually. These positions often require advanced degrees, extensive experience, and leadership responsibilities, with compensation including base salary, bonuses, and stock options.

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, advanced certifications, and leadership skills in managing regulatory strategies across global markets.

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.

Which is better, RA or QA?

In Regulatory Operations, RA (Regulatory Affairs) focuses on ensuring compliance with regulations and managing submissions to authorities, while QA (Quality Assurance) emphasizes maintaining product quality through audits and process controls. Both roles are essential, with RA often requiring knowledge of regulatory guidelines and QA emphasizing quality standards like GMP or ISO. The choice depends on whether you prefer regulatory compliance or quality management within the industry.
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Regulatory Operations jobs near you
Senior Manager, Commercial Regulatory Operations

Senior Manager, Commercial Regulatory Operations

Corcept Therapeutics

Redwood City, CA • On-site

$194K - $227K/yr

Full-time

Posted 6 days ago

Job description

For more than 25 years, Corcept has been singularly focused on the science of cortisol, a powerful hormone that when unregulated, can play a role in a broad range of diseases.
Our commercial portfolio includes treatments for hypercortisolism and oncology, and the company has discovered more than 1,000 proprietary selective cortisol modulators and glucocorticoid receptor antagonists. With advanced clinical trials in patients with hypercortisolism, solid tumors, ALS and liver disease, Corcept is unlocking the power of cortisol modulation to help address some of the most devastating diseases patients face today.
Corcept is headquartered in Redwood City, California. To learn more, visit www.corcept.com.
The Senior Manager, Commercial Regulatory Operations, will support the end-to-end review and approval process for promotional and non-promotional materials, ensuring timely, compliant, and efficient execution across cross-functional teams. At Corcept, this review process is known as the "Content Review Team" (or "CRT"), which brings together three compliance disciplines (regulatory, legal, and medical) for review and approval of materials. This role will oversee and coordinate CRT logistics and operations with Veeva Vault system management.
This role requires strong organizational skills, familiarity with industry tools, and a collaborative mindset to help drive process excellence, audit readiness, and continuous improvement within a fast-paced, launch-focused environment. This is an excellent opportunity for someone looking to expand their pharmaceutical operations experience while contributing to a patient-centered, mission-driven company aiming to revolutionize the treatment of serious diseases.
This is a hybrid role typically requiring on-site presence at least 3 days per week.
Responsibilities:
  • Manage the end-to-end content review and approval process for promotional and non-promotional materials using the Veeva document management system
  • Drive process improvement and operational efficiency initiatives within the CRT workflow
  • Support system maintenance and enhancements in Veeva PromoMats and MedComms by managing administrative updates and light configuration changes
  • Partner with Marketing teams on the development and maintenance of our claims and reference libraries
  • Collaborate closely with Regulatory, Medical, and Legal colleagues to maintain efficient CRT workflows necessary for review and approval of all product and disease-related content proposed by Marketing, Medical Affairs or other teams and their agencies to communicate with external audiences
  • Lead the planning and facilitation of CRT meetings, managing agenda creation, calendar coordination, expedited review processing, material quality checks, and consensus documentation
  • In partnership with Regulatory colleagues, prepare timely and accurate FDA Form 2253 submissions
  • Monitor and report on approval metrics to drive transparency, accountability, and data-informed decision-making across the review process
  • Support prioritization and capacity planning to ensure review activities align with business objectives and key timelines
  • Provide onboarding and training for CRT reviewers and content creators, such as marketers and their agencies, on CRT processes, system navigation, and best practices
  • Provide project oversight and vendor management for ongoing enhancements and upgrades within our Veeva system

Preferred Skills, Qualifications and Technical Proficiencies:
  • Expertise in Veeva PromoMats/MedComms and promotional/non-promotional material review processes
  • Ability to manage without direct authority and influence colleagues effectively
  • Excellent analytical, problem-solving, and communication skills
  • Highly organized, detail-oriented, and adaptable

Preferred Education and Experience:
  • BA/BS Degree in health/life sciences or related field
  • 6+years' experience in pharmaceutical, life sciences, or related industry, including experience leading or supporting review committee meetings
  • Product launch and pre-approval commercialization experience
  • Experience in AI implementation, claims library maintenance, and Veeva administrative support

The pay range that the Company reasonably expects to pay for this headquarters-based position is $194,000 - $227,000; the pay ultimately offered may vary based on legitimate considerations, including geographic location, job-related knowledge, skills, experience, and education.
Applicants must be currently authorized to work in the United States on a full-time basis.
For information on how Corcept collects, uses, discloses, protects, and otherwise processes personal information and an explanation of the rights and choices available to you with respect to your personal information, please refer to our Privacy Notice link.
Corcept appreciates the commitment and hard work of all our team members as we strive to discover and develop novel treatments for patients with serious unmet medical needs.
Please visit our website at: https://www.corcept.com/
Corcept is an Equal Opportunity Employer
Corcept will not conduct interviews via text message or messaging platforms and will not ask you to download anything as part of your interview. Though we use third-party tools to help with advertising our jobs, please be vigilant in checking that the communication is in fact coming from Corcept.

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