Regulatory Affairs Manager Career

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

Is Regulatory Affairs Manager the right career path for you?
Take the MyMajors Quiz and find out if it fits one of your top recommended majors!

Regulatory Affairs Manager Career

What Regulatory Affairs Managers do:

  • Communicate regulatory information to multiple departments and ensure that information is interpreted correctly.
  • Formulate or implement regulatory affairs policies and procedures to ensure that regulatory compliance is maintained or enhanced.
  • Maintain current knowledge of relevant regulations, including proposed and final rules.
  • Monitor emerging trends regarding industry regulations to determine potential impacts on organizational processes.
  • Oversee documentation efforts to ensure compliance with domestic and international regulations and standards.
  • Provide responses to regulatory agencies regarding product information or issues.
  • Review all regulatory agency submission materials to ensure timeliness, accuracy, comprehensiveness, or compliance with regulatory standards.
  • Develop and maintain standard operating procedures or local working practices.
  • Develop regulatory strategies and implementation plans for the preparation and submission of new products.
  • Direct the preparation and submission of regulatory agency applications, reports, or correspondence.
  • Establish regulatory priorities or budgets and allocate resources and workloads.
  • Provide regulatory guidance to departments or development project teams regarding design, development, evaluation, or marketing of products.
  • Contribute to the development or implementation of business unit strategic and operating plans.
  • Manage activities such as audits, regulatory agency inspections, or product recalls.
  • Establish procedures or systems for publishing document submissions either in hardcopy or electronic formats.
  • Represent organizations before domestic or international regulatory agencies on major policy matters or decisions regarding company products.
  • Review materials such as marketing literature or user manuals to ensure that regulatory agency requirements are met.
  • Train staff in regulatory policies or procedures.
  • Implement or monitor complaint processing systems to ensure effective and timely resolution of all complaint investigations.
  • Participate in the development or implementation of clinical trial protocols.
  • Investigate product complaints and prepare documentation and submissions to appropriate regulatory agencies as necessary.
  • Evaluate new software publishing systems and confer with regulatory agencies concerning news or updates related to electronic publishing of submissions.
  • Coordinate internal discoveries and depositions with legal department staff.

What work activities are most important?

Importance Activities

Evaluating Information to Determine Compliance with Standards - Using relevant information and individual judgment to determine whether events or processes comply with laws, regulations, or standards.

Getting Information - Observing, receiving, and otherwise obtaining information from all relevant sources.

Communicating with Supervisors, Peers, or Subordinates - Providing information to supervisors, co-workers, and subordinates by telephone, in written form, e-mail, or in person.

Communicating with Persons Outside Organization - Communicating with people outside the organization, representing the organization to customers, the public, government, and other external sources. This information can be exchanged in person, in writing, or by telephone or e-mail.

Updating and Using Relevant Knowledge - Keeping up-to-date technically and applying new knowledge to your job.

Organizing, Planning, and Prioritizing Work - Developing specific goals and plans to prioritize, organize, and accomplish your work.

Establishing and Maintaining Interpersonal Relationships - Developing constructive and cooperative working relationships with others, and maintaining them over time.

Making Decisions and Solving Problems - Analyzing information and evaluating results to choose the best solution and solve problems.

Documenting/Recording Information - Entering, transcribing, recording, storing, or maintaining information in written or electronic/magnetic form.

Interpreting the Meaning of Information for Others - Translating or explaining what information means and how it can be used.

Interacting With Computers - Using computers and computer systems (including hardware and software) to program, write software, set up functions, enter data, or process information.

Developing Objectives and Strategies - Establishing long-range objectives and specifying the strategies and actions to achieve them.

Analyzing Data or Information - Identifying the underlying principles, reasons, or facts of information by breaking down information or data into separate parts.

Resolving Conflicts and Negotiating with Others - Handling complaints, settling disputes, and resolving grievances and conflicts, or otherwise negotiating with others.

Identifying Objects, Actions, and Events - Identifying information by categorizing, estimating, recognizing differences or similarities, and detecting changes in circumstances or events.

Processing Information - Compiling, coding, categorizing, calculating, tabulating, auditing, or verifying information or data.

Scheduling Work and Activities - Scheduling events, programs, and activities, as well as the work of others.

Developing and Building Teams - Encouraging and building mutual trust, respect, and cooperation among team members.

Coordinating the Work and Activities of Others - Getting members of a group to work together to accomplish tasks.

Provide Consultation and Advice to Others - Providing guidance and expert advice to management or other groups on technical, systems-, or process-related topics.

Coaching and Developing Others - Identifying the developmental needs of others and coaching, mentoring, or otherwise helping others to improve their knowledge or skills.

Guiding, Directing, and Motivating Subordinates - Providing guidance and direction to subordinates, including setting performance standards and monitoring performance.

Training and Teaching Others - Identifying the educational needs of others, developing formal educational or training programs or classes, and teaching or instructing others.

Thinking Creatively - Developing, designing, or creating new applications, ideas, relationships, systems, or products, including artistic contributions.

Performing Administrative Activities - Performing day-to-day administrative tasks such as maintaining information files and processing paperwork.

Staffing Organizational Units - Recruiting, interviewing, selecting, hiring, and promoting employees in an organization.

Monitor Processes, Materials, or Surroundings - Monitoring and reviewing information from materials, events, or the environment, to detect or assess problems.

Selling or Influencing Others - Convincing others to buy merchandise/goods or to otherwise change their minds or actions.

Judging the Qualities of Things, Services, or People - Assessing the value, importance, or quality of things or people.

Estimating the Quantifiable Characteristics of Products, Events, or Information - Estimating sizes, distances, and quantities; or determining time, costs, resources, or materials needed to perform a work activity.

Monitoring and Controlling Resources - Monitoring and controlling resources and overseeing the spending of money.

Inspecting Equipment, Structures, or Material - Inspecting equipment, structures, or materials to identify the cause of errors or other problems or defects.

Holland Code Chart for a Regulatory Affairs Manager

Is This Career Right for Me?

The fastest way toward knowing if regulatory-affairs-managers is the career for you is to take this quiz to find your career path.