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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