Regulatory Affairs Manager

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

A Day in the Life of a Regulatory Affairs Manager
? Develop and maintain standard operating procedures or local working practices.
? Participate in the development or implementation of clinical trial protocols.
? Train staff in regulatory policies or procedures.
? Monitor emerging trends regarding industry regulations to determine potential impacts on organizational processes.
? Contribute to the development or implementation of business unit strategic and operating plans.
? Represent organizations before domestic or international regulatory agencies on major policy matters or decisions regarding company products.

What Skills Do You Need to Work as a Regulatory Affairs Manager?

These are the skills Regulatory Affairs Managers say are the most useful in their careers:
? WritingCommunicating effectively in writing as appropriate for the needs of the audience.
? SpeakingTalking to others to convey information effectively.
? Reading ComprehensionUnderstanding written sentences and paragraphs in work-related documents.
? Critical ThinkingUsing logic and reasoning to identify the strengths and weaknesses of alternative solutions, conclusions, or approaches to problems.
? Active ListeningGiving 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.
? MonitoringMonitoring/Assessing performance of yourself, other individuals, or organizations to make improvements or take corrective action.

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