Regulatory Affairs Manager Career

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


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Regulatory Affairs Manager Career

What Regulatory Affairs Managers do:

  • Communicate regulatory information to multiple departments and ensure that information is interpreted correctly.
  • Contribute to the development or implementation of business unit strategic and operating plans.
  • 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 documentation efforts to ensure compliance with domestic and international regulations and standards.
  • Direct the preparation and submission of regulatory agency applications, reports, or correspondence.
  • Establish procedures or systems for publishing document submissions in hardcopy or electronic formats.
  • Establish regulatory priorities or budgets and allocate resources and workloads.
  • Evaluate new software publishing systems and confer with regulatory agencies concerning news or updates on electronic publishing of submissions.
  • 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.
  • Provide regulatory guidance to departments or development project teams regarding design, development, evaluation, or marketing of products.
  • 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.
  • Train staff in regulatory policies or procedures.
  • Manage activities such as audits, regulatory agency inspections, or product recalls.
  • Monitor emerging trends regarding industry regulations to determine potential impacts on organizational processes.
  • 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.
  • Participate in the development or implementation of clinical trial protocols.
  • 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.
  • Monitor regulatory affairs activities to ensure their alignment with corporate sustainability or green initiatives.
  • Monitor regulatory affairs trends related to environmental issues.
  • Coordinate internal discoveries and depositions with legal department staff.
  • Develop relationships with state or federal environmental regulatory agencies to learn about and analyze the potential impacts of proposed environmental policy regulations.
  • Evaluate regulatory affairs aspects that are specifically green, such as the use of toxic substances in packaging, carbon footprinting issues, or green policy implementation.

What work activities are most important?

Importance Activities

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

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.

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

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

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

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

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.

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

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

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

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

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

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

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.

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

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.

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

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

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

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

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

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

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

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.

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

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

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

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

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

Holland Code Chart for a Regulatory Affairs Manager