Regulatory Affairs Associate
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What Does a Regulatory Affairs Associate Do?
Regulatory Affairs Associates assist in obtaining and maintaining government approval for pharmaceuticals and medical devices. Typically these positions work within an office of regulatory affairs where they work on document preparation, information management, file maintenance, and coordination of tasks across multiple departments.
Your Manager will expect you to understand all aspects of product development, including research, clinical trials, manufacturing practices, regulations, and approval processes. In the role you will be responsible for:
- Review of product labeling, batch records, specification sheets, or test methods for compliance with applicable regulations and policies
- Advise project teams on subjects such as premarket regulatory requirements, export and labeling requirements, or clinical study compliance issues.
- Determine the types of regulatory submissions or internal documentation that are required in situations such as proposed device changes or labeling changes.
- Explain timelines, regulations, policies, or procedures to the cross functional team
- Maintain data in information systems or databases as designated by your organization both local and global
- Ensure compliance with regulations across the therapy area you are responsible for
- Provide technical review of data or reports for products to be submitted to regulatory authorities
- Coordinate regulatory documentation activities between the local and global organization and also the government regulatory bodies
