What are the Key Responsibilities of Regulatory Affairs Specialists?
Regulatory Affairs Specialists have a wide range of responsibilities, including:
- Ensuring Compliance: They ensure that the company complies with all applicable regulations and standards. - Documentation: They prepare and submit regulatory documents to government agencies. - Product Approval: They assist in gaining product approvals, including new drug applications, medical device submissions, and food safety certifications. - Risk Management: They identify and mitigate regulatory risks that could impact the business. - Communication: They act as a liaison between the company and regulatory authorities.