Senior Regulatory Affairs Specialist
Current- Implements processes involved with maintaining annual licenses, registrations, and listings.
- Reviews and approves advertising and promotion to ensure regulatory compliance.
- Submits notifiable changes and supplemental dossiers to the appropriate regulatory authorities to update product information and/or instructions for use to reflect current state of product knowledge.
- Implements regulatory strategy and processes for handling recalls and communication to stakeholders (e.g. HCP, patient, distributor, and health authorities).
- Provides required information in support of product reimbursement requests.
- Assesses regulatory intelligence to assist in the development of local and regional, regulatory strategies.