Regulatory Affairs Manager

Also called: Global Regulatory Affairs Director (Global RA Director), Global Regulatory Affairs Manager (Global RA Manager), Regulatory Administrator, Regulatory Affairs Director (RA Director), Regulatory Affairs Manager (RA Manager)

Regulatory Affairs Manager

Varies

estimated salary

Regulatory affairs managers plan, direct, or coordinate production activities of an organization to ensure compliance with regulations and standard operating procedures.

 

 

  • Provide responses to regulatory agencies regarding product information or issues.
  • Direct the preparation and submission of regulatory agency applications, reports, or correspondence.
  • Review all regulatory agency submission materials to ensure timeliness, accuracy, comprehensiveness, or compliance with regulatory standards.
  • Develop regulatory strategies and implementation plans for the preparation and submission of new products.
  • Manage activities such as audits, regulatory agency inspections, or product recalls.
  • 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.
  • Review materials such as marketing literature or user manuals to ensure that regulatory agency requirements are met.
  • Communicate regulatory information to multiple departments and ensure that information is interpreted correctly.
  • Provide regulatory guidance to departments or development project teams regarding design, development, evaluation, or marketing of products.
  • Direct documentation efforts to ensure compliance with domestic and international regulations and standards.
  • Monitor emerging trends regarding industry regulations to determine potential impacts on organizational processes.
  • Investigate product complaints and prepare documentation and submissions to appropriate regulatory agencies as necessary.
  • Represent organizations before domestic or international regulatory agencies on major policy matters or decisions regarding company products.
  • Train staff in regulatory policies or procedures.
  • Develop and maintain standard operating procedures or local working practices.
  • 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.
  • Contribute to the development or implementation of business unit strategic and operating plans.
  • Establish procedures or systems for publishing document submissions in hardcopy or electronic formats.
  • 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.
  • 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.
  • Monitor regulatory affairs activities to ensure their alignment with corporate sustainability or green initiatives.
  • Monitor regulatory affairs trends related to environmental issues.
  • Evaluate regulatory affairs aspects that are specifically green, such as the use of toxic substances in packaging, carbon footprinting issues, or green policy implementation.
Work Context
  • Electronic Mail — 100% responded "Every day".
  • Telephone — 93% responded "Every day".
  • Face-to-Face Discussions — 86% responded "Every day".
  • Spend Time Sitting — 83% responded "Continually or almost continually".
  • Indoors, Environmentally Controlled — 93% responded "Every day".
  • Importance of Being Exact or Accurate — 61% responded "Extremely important".
  • Work With Work Group or Team — 58% responded "Extremely important".
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Work 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.
  • Updating and Using Relevant Knowledge — Keeping up-to-date technically and applying new knowledge to your job.
  • Making Decisions and Solving Problems — Analyzing information and evaluating results to choose the best solution and solve problems.
  • 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.
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Detailed Work Activities
  • Manage control system activities in organizations.
  • Implement organizational process or policy changes.
  • Develop organizational policies or programs.
  • Develop operating strategies, plans, or procedures.
  • Advise others on legal or regulatory compliance matters.
  • Communicate organizational policies and procedures.
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Knowledge

English Language
  • Knowledge of the structure and content of the English language including the meaning and spelling of words, rules of composition, and grammar.
Law and Government
  • Knowledge of laws, legal codes, court procedures, precedents, government regulations, executive orders, agency rules, and the democratic political process.
Administration and Management
  • Knowledge of business and management principles involved in strategic planning, resource allocation, human resources modeling, leadership technique, production methods, and coordination of people and resources.
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Skills

Reading Comprehension
  • Understanding written sentences and paragraphs in work related documents.
Writing
  • Communicating effectively in writing as appropriate for the needs of the audience.
Speaking
  • Talking to others to convey information effectively.
Active Listening
  • Giving full attention to what other people are saying, taking time to understand the points being made, asking questions as appropriate, and not interrupting at inappropriate times.
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Abilities

Written Comprehension
  • The ability to read and understand information and ideas presented in writing.
Written Comprehension
  • The ability to read and understand information and ideas presented in writing.
Oral Comprehension
  • The ability to listen to and understand information and ideas presented through spoken words and sentences.
Written Expression
  • The ability to communicate information and ideas in writing so others will understand.
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Personality

People interested in this work like activities that include ideas, thinking, and figuring things out.
They do well at jobs that need:
  • Achievement/Effort
  • Persistence
  • Initiative
  • Leadership
  • Cooperation
  • Concern for Others
  • Social Orientation
  • Self Control
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Technology

You might use software like this on the job:

Business intelligence and data analysis software
  • Tableau Hot Technology
Word processing software
  • Microsoft Word Hot Technology
  • Word processing software
Enterprise resource planning ERP software
  • SAP Hot Technology
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