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Regulatory specialist vs regulatory affairs manager

The differences between regulatory specialists and regulatory affairs managers can be seen in a few details. Each job has different responsibilities and duties. It typically takes 2-4 years to become both a regulatory specialist and a regulatory affairs manager. Additionally, a regulatory affairs manager has an average salary of $117,714, which is higher than the $70,575 average annual salary of a regulatory specialist.

The top three skills for a regulatory specialist include FDA, regulatory compliance and regulatory agencies. The most important skills for a regulatory affairs manager are regulatory affairs, FDA, and medical devices.

Regulatory specialist vs regulatory affairs manager overview

Regulatory SpecialistRegulatory Affairs Manager
Yearly salary$70,575$117,714
Hourly rate$33.93$56.59
Growth rate--
Number of jobs6,25012,569
Job satisfaction5-
Most common degreeBachelor's Degree, 62%Bachelor's Degree, 64%
Average age4647
Years of experience44

What does a regulatory specialist do?

A regulatory specialist is responsible for evaluating all the business processes, functions, and requirements and ensure its compliance with the company's protocols and state regulations. Regulatory specialists conduct regular audits, review the company's documents and business transactions, renew permits and licenses, and submit necessary files required by regulatory agencies. They coordinate with the management to revise the company's handbook accordingly and disseminate information on any changes across the organization. A regulatory specialist may also facilitate training programs and orientation to inform the employees on risk policies to avoid reputational issues, potential hazards, and delays in operations.

What does a regulatory affairs manager do?

A regulatory affairs manager is in charge of ensuring that all aspects of a company adhere to the rules and regulations set by regulatory agencies. Their responsibilities revolve around devising regulation compliance strategies, creating training and orientation programs to inform the staff on the policies and standards, conducting internal inspections and information drives, and keeping abreast with the latest rules and regulations. Moreover, a regulatory affairs manager is in charge of processing and submitting necessary documents to government agencies, ensuring compliance and timeliness.

Regulatory specialist vs regulatory affairs manager salary

Regulatory specialists and regulatory affairs managers have different pay scales, as shown below.

Regulatory SpecialistRegulatory Affairs Manager
Average salary$70,575$117,714
Salary rangeBetween $49,000 And $100,000Between $78,000 And $177,000
Highest paying CitySan Francisco, CASan Rafael, CA
Highest paying stateMinnesotaVermont
Best paying companyCargillMcKinsey & Company Inc
Best paying industry--

Differences between regulatory specialist and regulatory affairs manager education

There are a few differences between a regulatory specialist and a regulatory affairs manager in terms of educational background:

Regulatory SpecialistRegulatory Affairs Manager
Most common degreeBachelor's Degree, 62%Bachelor's Degree, 64%
Most common majorBusinessBusiness
Most common collegeStanford UniversityUniversity of Southern California

Regulatory specialist vs regulatory affairs manager demographics

Here are the differences between regulatory specialists' and regulatory affairs managers' demographics:

Regulatory SpecialistRegulatory Affairs Manager
Average age4647
Gender ratioMale, 29.9% Female, 70.1%Male, 45.8% Female, 54.2%
Race ratioBlack or African American, 11.6% Unknown, 4.5% Hispanic or Latino, 15.5% Asian, 8.1% White, 59.5% American Indian and Alaska Native, 0.8%Black or African American, 7.7% Unknown, 4.7% Hispanic or Latino, 12.8% Asian, 9.0% White, 65.1% American Indian and Alaska Native, 0.7%
LGBT Percentage12%10%

Differences between regulatory specialist and regulatory affairs manager duties and responsibilities

Regulatory specialist example responsibilities.

  • Utilize the``SharePoint"system to manage the document change control process and maintain configuration control.
  • Manage and submit regulatory permit and notification applications to USDA to import, move and release regulate plant materials.
  • Assess study results for adherence to 40 CFR EPA regulatory requirements.
  • Stay abreast of developments in GCP and federal regulations regarding clinical research.
  • Assist with QC and QA of various study relate regulatory documents and reports.
  • Assist with training and mentoring of junior regulatory specialists and assist with departmental QC and QA activities.
  • Show more

Regulatory affairs manager example responsibilities.

  • Implement and achieve ISO 9001 and ISO 13485 registrations for the first time for the company.
  • Manage team which monitor the clinics' daily, weekly and monthly water and equipment maintenance requirements to meet CMS regulations.
  • Manage departmental and special project economics, including oversight of budgeting, expense management, and reimbursement billing.
  • Coordinate, oversee and audit record-keeping requirements of DEA, OSHA, D.O.T.
  • Conduct a comprehensive risk assessment of health plan with results from CMS audit as benchmark.
  • Perform all AML functions on new and existing customers, including OFAC checks and CIP.
  • Show more

Regulatory specialist vs regulatory affairs manager skills

Common regulatory specialist skills
  • FDA, 10%
  • Regulatory Compliance, 8%
  • Regulatory Agencies, 7%
  • Regulatory Submissions, 5%
  • Customer Service, 5%
  • Clinical Trials, 4%
Common regulatory affairs manager skills
  • Regulatory Affairs, 11%
  • FDA, 8%
  • Medical Devices, 6%
  • Regulatory Submissions, 5%
  • Regulatory Agencies, 5%
  • Global Regulatory, 5%

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