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Regulatory Operations Jobs in Raleigh, NC (NOW HIRING)

Arclin

Operations Manager III

Moncure, NC

This position ensures that the plant is operating in compliance with all regulatory and company policies, procedures and regulations. Operations Manager Job Responsibilities: * The Operations Manager ...

Arclin USA LLC

Operations Manager III

Moncure, NC

This position ensures that the plant is operating in compliance with all regulatory and company policies, procedures and regulations. Operations Manager Job Responsibilities: * The Operations Manager ...

Arclin

Operations Manager III

Moncure, NC · On-site

This position ensures that the plant is operating in compliance with all regulatory and company policies, procedures and regulations. Operations Manager Job Responsibilities: * The Operations Manager ...

MMS

Nonclinical Writer

Raleigh, NC · On-site

Collaborate with cross-functional teams such as project management, safety, efficacy, biostats, regulatory operations, and CMC * Demonstrated ability to lead others to complete complex projects

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Regulatory Operations information

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How much do regulatory operations jobs pay per hour?

As of Aug 17, 2026, the average hourly pay for regulatory operations in Raleigh, NC is $25.51, according to ZipRecruiter salary data. Most workers in this role earn between $17.31 and $29.42 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 working closely with cross-functional teams such as R&D, quality, and legal. Their work supports the timely approval and ongoing compliance of products in regulated industries like 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.

What are the key skills and qualifications needed to thrive in regulatory operations, 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 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.

What are the most commonly searched types of Regulatory Operations jobs in Raleigh, NC?

The most popular types of Regulatory Operations jobs in Raleigh, NC are:

What are popular job titles related to Regulatory Operations jobs in Raleigh, NC?

For Regulatory Operations jobs in Raleigh, NC, the most frequently searched job titles are:

What job categories do people searching Regulatory Operations jobs in Raleigh, NC look for?

The top searched job categories for Regulatory Operations jobs in Raleigh, NC are:

Regulatory Operations jobs near you
Infographic showing various Regulatory Operations job openings in Raleigh, NC as of August 2026, with employment types broken down into 85% Full Time, 12% Part Time, 1% Temporary, and 2% Contract. Highlights an 94% Physical, 2% Hybrid, and 4% Remote job distribution, with an average salary of $53,061 per year, or $25.5 per hour.

Senior Manager, Regulatory Affairs

Azurity Pharmaceuticals - US

Raleigh, NC • On-site

Full-time

Medical, Dental, Vision, Retirement, PTO

Posted 7 days ago

Job description

Azurity Pharmaceuticals is a privately held, specialty pharmaceutical company that focuses on innovative products that meet the needs of underserved patients. As an industry leader in providing unique, accessible, and high-quality medications, Azurity leverages its integrated capabilities and vast partner network to continually expand its broad commercial product portfolio and robust late-stage pipeline. The company's patient-centric products span the cardiovascular, neurology, endocrinology, gastro-intestinal, institutional, and orphan markets, and have benefited millions of patients. For more information, visit www.azurity.com.
Azurity Pharmaceuticals is proud to be an inclusive workplace and an Equal Opportunity Employer. Azurity's success is attributable to our incredibly talented, dedicated team that focuses on benefiting the lives of patients by bringing the best science and commitment to quality into everything that we do. We seek highly motivated individuals with the dedication, integrity, and creative spirit needed to thrive in our organization.
Brief team/department description:
As a part of the Regulatory Affairs team at Azurity, the Regulatory Affairs Manager will be responsible for overseeing and managing the regulatory activities for assigned products/projects and will serve as the regulatory representative on cross-functional teams for assigned projects. Project may support developmental product activities as well as the life-cycle management of commercial products. Responsibilities include providing regulatory guidance, determining requirements and strategy for assigned projects, authoring Health Authority (HA) submissions for US and for Canada, and ensuring compliance with regulations, company standards and commitments.
Principle Responsibilities:
  • Represent Regulatory Affairs on assigned product and related project teams (both internal and external cross-functional teams)
  • Provide regulatory assessment of due diligence requests to support new business development activities.
  • Serve as primary interface with FDA and Health Canada for assigned products. Prepare and author portions of Health Authority meeting request and briefing documents. Attend Health Authority meetings as assigned.
  • Drive regulatory strategies for drug product registration and for life-cycle management across North America.
  • Manage regulatory filings including IND, NDA, ANDA, NDS, DMF for a variety of dosage forms including solid oral, parenteral, liquids, topicals, inhalation and nasal, and drug/device combination drug products. Respond to FDA or Health Canada Requests for Information.
  • Manage operational aspects of preparing compliant submissions to regulatory agencies.
  • Establish and manage timelines associated with regulatory submissions.
  • Manage archive of regulatory submissions, regulatory correspondence and associated logs and tracking mechanisms as per Azurity SOPs.
  • Provide regulatory guidance on requirements for post-approval/life-cycle changes, as required, for assigned commercial products including change control assessments.
  • Provide regulatory support for Senior Leadership Team (SLT) and Executive Leadership Team (ELT) meetings and presentations.
  • Monitor evolving, region-specific regulations and proactively provide strategic guidance to cross-functional teams to ensure compliance.
  • Assist in preparing budgets and reviewing invoices on assigned projects and relevant product/filing fees, as needed.
  • Participate in various activities of setting goals, tracking deliverables and process improvements within the regulatory department.

Qualifications and Education Requirements
  • Minimum Bachelor of Science or preferred advanced health care discipline degree (PharmD, PhD, Master of Science, etc.) or equivalent qualification.
  • Minimum of 10 years in the pharmaceutical industry with at least 8 of those years in regulatory affairs.
  • Combination of education and applicable job experience may be considered.
  • Excellent organizational, interpersonal, verbal, and written communication skills, strong grammar, and proofreading/editing skills, and MS Office skills are required.
  • Track record of successfully working with cross-functional teams, including external partners
  • Ability to work independently with minimal supervision in a fast-paced deadline driven environment.
  • Keen attention to detail.
  • Ability to rapidly adapt to changing environment and circumstances that require flexibility, tolerance and a great sense of urgency while ensuring that all regulatory requirements are met.
  • Ability to successfully communicate, negotiate and influence regulatory strategy to key stakeholders.

#LI-Hybrid
#LI-Full-time
Physical & Mental Requirements:
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
  • Must be able to sit for long periods of time
  • While performing the duties of this job, the employee is frequently required to stand; walk; sit; talk and/or hear
  • May occasionally climb stairs and/or ride elevators
  • The employee must occasionally lift and/or move up to 25 pounds
  • Employee must be able to manipulate keyboard, operate a telephone and hand-held devices
  • Other miscellaneous job duties as required

Benefits We Offer:
  • Unlock Your Earning Potential: Join our team and be rewarded with a competitive compensation package, including an annual bonus based on company performance, that recognizes your exceptional talent.
    • Sales - In lieu of annual bonuses, we offer an Incentive compensation program that allows you to earn more - even over plan.
    • Fuel Your Success: *Sales Only* - We understand the value of your hard work and provide a car reimbursement program and gas card for both business and personal use as part of our commitment to supporting you.
  • Comprehensive Health Coverage: We value your well-being and offer excellent medical, dental, vision, and prescription coverage to ensure you and your family are always taken care of.
  • Flexibility for Your Lifestyle: Achieve work-life balance with our hybrid work model, allowing you to work two days from home and three days in the office. *Excludes Sales, Manufacturing, and some Operations positions*
  • Invest in Your Future: Our Retirement Savings Plan (401K) is designed to help you secure a comfortable retirement by matching dollar for dollar up to 5%.
  • Time Off That Counts: Take advantage of our generous time off policy, which offers up to 15 vacation days annually + rollover (up to 40 hours) as well as five sick/wellness days. For new employees, vacation accrual will be prorated based on your start date.
  • Meaningful Time with Your Loved Ones: We close between Christmas and New Year's to give you an extra week off to spend quality time with your family and recharge.
  • Enjoy the Holidays: Over the course of the year, Azurity recognizes 13 holidays.
  • Invest in Your Education: We support your professional growth with tuition reimbursement for undergraduate and graduate level courses or certifications.
  • Recognize and Be Recognized: Our Azurity High Five peer recognition platform allows you to celebrate your colleagues' accomplishments and receive recognition for your own outstanding work.

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