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Management

Regulatory Affairs Managers

Also called: CMC Director (Chemistry, Manufacturing, and Controls Director), Compliance Director, Global RA Director (Global Regulatory Affairs Director), Global RA Manager (Global Regulatory Affairs Manager)

US median pay

$141,900

per year, 2025

Job growth 2025–35

+4.9%

about average or slower

Openings a year (US)

100,900

1,338,800 employed

Typical entry education

Bachelor's degree

Preparation 4/5 · Considerable preparation

What this job is

Plan, direct, or coordinate production activities of an organization to ensure compliance with regulations and standard operating procedures.

What they do day to day

  • Develop regulatory strategies and implementation plans for the preparation and submission of new products.
  • Review all regulatory agency submission materials to ensure timeliness, accuracy, comprehensiveness, or compliance with regulatory standards.
  • Direct the preparation and submission of regulatory agency applications, reports, or correspondence.
  • Investigate product complaints and prepare documentation and submissions to appropriate regulatory agencies as necessary.
  • Provide responses to regulatory agencies regarding product information or issues.
  • Represent organizations before domestic or international regulatory agencies on major policy matters or decisions regarding company products.
  • Provide regulatory guidance to departments or development project teams regarding design, development, evaluation, or marketing of products.
  • Manage activities such as audits, regulatory agency inspections, or product recalls.
  • Communicate regulatory information to multiple departments and ensure that information is interpreted correctly.
  • Maintain current knowledge of relevant regulations, including proposed and final rules.

Skills and knowledge that matter most

Skills

  • Systems Evaluation3.8/5
  • Systems Analysis3.8/5
  • Judgment and Decision Making3.8/5
  • Complex Problem Solving3.8/5
  • Time Management3.6/5
  • Coordination3.5/5
  • Social Perceptiveness3.2/5
  • Instructing3.2/5

Knowledge

  • English Language4.6/5
  • Law and Government4.0/5
  • Administration and Management3.7/5
  • Biology3.4/5
  • Education and Training3.1/5
  • Chemistry3.0/5

Importance rated by people working in the job (1 = not important, 5 = extremely important).

Education and preparation

Preparation level 4 of 5 — Considerable preparation. Usually a bachelor's degree and several years of related experience.

Typical entry education (BLS): Bachelor's degree, plus less than 5 years of related work experience.

Highest education of people in this job:

  • Bachelor's degree74%
  • Master's degree13%

Who this job suits

Mostly Enterprising

Leading, persuading and starting things

Conventional

Organising data, details and procedures

Based on the Holland (RIASEC) interest profile for this occupation.

Job titles you'll see in postings

CMC Director (Chemistry, Manufacturing, and Controls Director)Compliance DirectorGlobal RA Director (Global Regulatory Affairs Director)Global RA Manager (Global Regulatory Affairs Manager)RA Director (Regulatory Affairs Director)RA Manager (Regulatory Affairs Manager)RA QA Director (Regulatory Affairs Quality Assurance Director)RA VP (Regulatory Affairs Vice President)Regulatory DirectorVaccine RA Director (Vaccine Regulatory Affairs Director)