Careers and Occupations

Regulatory Affairs Managers

Regulatory Affairs Managers

Regulatory Affairs Managers Videos


Related Areas of Study
Related Areas of Study
Regulatory Affairs Managers Description

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

Regulatory Affairs Managers Related Job Titles

Pharmaceutical Quality Assurance Manager, Quality Assurance Director, Quality Assurance Supervisor, Regulatory Administrator, Regulatory Affairs Director, Regulatory Affairs Manager, Regulatory Process Manager,


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

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