In this day in the life guide, you will find out:
- What does a day as Regulatory Affairs Specialists looks like
- What do they do every day
- Things they do on a weekly or monthly basis
- How many hours do they work
The purpose of this is to give you a clear picture of this career so you can make a better career decision on whether this career is suitable for you or not.
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Typical Day for Regulatory Affairs Specialists
Here is a list of tasks that Regulatory Affairs Specialists do every day.
- Maintain current knowledge base of existing and emerging regulations, standards, or guidance documents.
- Interpret regulatory rules or rule changes and ensure that they are communicated through corporate policies and procedures.
- Coordinate efforts associated with the preparation of regulatory documents or submissions.
- Compile and maintain regulatory documentation databases or systems.
- Determine regulations or procedures related to the management, collection, reuse, recovery, or recycling of packaging waste.
Weekly and Monthly Tasks
Here is a list of tasks that Regulatory Affairs Specialists do on a weekly or monthly basis.
- Provide technical review of data or reports that will be incorporated into regulatory submissions to assure scientific rigor, accuracy, and clarity of presentation.
- Review product promotional materials, labeling, batch records, specification sheets, or test methods for compliance with applicable regulations and policies.
- Determine the types of regulatory submissions or internal documentation that are required in situations such as proposed device changes or labeling changes.
- Advise project teams on subjects such as premarket regulatory requirements, export and labeling requirements, or clinical study compliance issues.
- Prepare or maintain technical files as necessary to obtain and sustain product approval.
- How many hours do Regulatory Affairs Specialists work per week? More than 40 hours per week
- What is the work schedule like? Regular (Set schedule and routine)
Indoors, Environmentally Controlled
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Related careers to Regulatory Affairs Specialists
This career is also closely related to Clinical Quality Assurance Associate, Clinical Quality Assurance Specialist, Drug Regulatory Affairs Specialist, Product Safety Specialist, Quality Assurance Documentation Coordinator, Quality Assurance Documentation Specialist, Quality Assurance Specialist, Quality Assurance/Regulatory Affairs Specialist (QA/RA Specialist), Regulatory Affairs Analyst or Regulatory Affairs Associate.