What You'll Do

  • Direct the preparation and submission of regulatory agency applications, reports, or correspondence.
  • Formulate or implement regulatory affairs policies and procedures to ensure that regulatory compliance is maintained or enhanced.
  • Provide regulatory guidance to departments or development project teams regarding design, development, evaluation, or marketing of products.
  • Communicate regulatory information to multiple departments and ensure that information is interpreted correctly.
  • Develop regulatory strategies and implementation plans for the preparation and submission of new products.
  • Establish regulatory priorities or budgets and allocate resources and workloads.
  • Implement or monitor complaint processing systems to ensure effective and timely resolution of all complaint investigations.
  • Investigate product complaints and prepare documentation and submissions to appropriate regulatory agencies as necessary.
  • Maintain current knowledge of relevant regulations, including proposed and final rules.
  • Manage activities such as audits, regulatory agency inspections, or product recalls.

Essential Skills

Writing 4.25/5
Reading Comprehension 4.12/5
Active Listening 4.0/5
Speaking 4.0/5
Critical Thinking 3.88/5
Complex Problem Solving 3.75/5
Judgment and Decision Making 3.75/5
Systems Analysis 3.75/5
Systems Evaluation 3.75/5
Monitoring 3.62/5
Time Management 3.62/5
Active Learning 3.5/5

Career Fit Overview

Use this summary to sense whether the day to day rhythm and focus of this path line up with what energizes you.

Top passions

  • Leader: Taking charge and moving ideas forward motivates you.
  • Organizer: Bringing order to data and processes satisfies you.
  • Analyst: Investigating problems and finding patterns keeps you engaged.

Common styles

Attention to Detail, Integrity, Dependability, Cooperation, Initiative

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Key Abilities

This career demands strong capabilities in the following areas:

Written Expression 4.25/5
Oral Comprehension 4.12/5
Written Comprehension 4.12/5
Oral Expression 4.12/5
Deductive Reasoning 3.88/5
Inductive Reasoning 3.88/5
Problem Sensitivity 3.75/5
Near Vision 3.75/5

Technologies & Tools

Adlib Express Adobe Acrobat Analyse-it Aris Global Register Axway eSubmissions Database software Datafarm a-Pulse Datafarm eCTDGatekeeper Datafarm eCTDViewer Datafarm S-Cubed Dialog DialogLink Document publishing software DoubleBridge ROSETTA Phoenix eCTD Viewer DoubleBridge ROSETTA Pyramid DoubleBridge ROSETTA Sceptre DoubleBridge ROSETTA Scribe Electronic common technical document eCTD software Electronic common technical document eCTD validating software Electronic common technical document eCTD viewing software Electronic document management system EDMS

Work Environment & Style

Common Styles for This Career

  • Attention to Detail (High importance: 4.78/5)
  • Integrity (High importance: 4.74/5)
  • Dependability (High importance: 4.57/5)
  • Cooperation (High importance: 4.3/5)
  • Initiative (High importance: 4.17/5)

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How to Become One

Most employers require a bachelor's degree in a relevant field. Some positions may also require experience through internships, co-ops, or entry-level work to strengthen your candidacy.

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Also Known As

This career is known by many different job titles across industries. Here are all the variations:

CMC Director (Chemistry, Manufacturing, and Controls Director) CMC Regulatory Affairs Manager (Chemistry, Manufacturing and Controls Regulatory Affairs Manager) Compliance Director Global RA Director (Global Regulatory Affairs Director) Global RA Manager (Global Regulatory Affairs Manager) RA and Compliance Director (Regulatory Affairs and Compliance Director) 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 Affairs Executive Regulatory Director Regulatory Manager Regulatory Oversight Manager Regulatory Process Manager Regulatory Program Manager Regulatory Reporting Manager Regulatory Reports Manager Vaccine RA Director (Vaccine Regulatory Affairs Director)