Regulatory Affairs Specialist

As a Regulatory Compliance Specialist, your primary responsibility will be to ensure that company products adhere to relevant regulatory requirements, including those stipulated by USFDA, FDA, EMA, and local regulatory bodies. You will be tasked with preparing and submitting regulatory documents such as INDs, NDAs, and MAAs to regulatory agencies. Additionally, you will play a pivotal role in developing and executing regulatory strategies that support product development and commercialization efforts. Your role will also involve staying abreast of evolving regulatory standards and providing guidance to internal stakeholders based on regulatory intelligence. You will coordinate and oversee regulatory audits and inspections, as well as review and approve product labeling and advertising materials to ensure compliance with regulations. Regular communication with regulatory agencies, such as the FDA, to address inquiries and issues will be part of your duties. Furthermore, you will be responsible for managing regulatory documentation, including submissions, approvals, and correspondence. Providing regulatory training and guidance to internal teams and monitoring company activities for compliance with regulatory requirements are also integral aspects of this role. This is a full-time, permanent position with a day shift schedule and a yearly bonus. The work location for this role is in-person.,