Job Description & Duties : Plan, 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: Writing : Communicating effectively in writing as appropriate for the needs of the audience. Speaking : Talking to others to convey information effectively. Reading Comprehension : Understanding written sentences and paragraphs in work-related documents. Critical Thinking : Using logic and reasoning to identify the strengths and weaknesses of alternative solutions, conclusions, or approaches to problems. 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. Monitoring : Monitoring/Assessing performance of yourself, other individuals, or organizations to make improvements or take corrective action. #J-18808-Ljbffr Course Advisor
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