Job Description

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.

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