Project Specialist - Regulatory Affairs
Fort Worth Metro Area, TX
- BS or MS 1-3 years of experience in the pharmaceutical industry, good working knowledge of Regulatory Affairs.
- Basic knowledge of FDA Regulatory/ specifically labeling experience preferred.
- Project Specialist is responsible for the tracking, monitoring and reporting on the global implementation of corporate agreed, safety related product information changes (Core Data Sheet- CDS amendments and updates)
- Provide support for Labeling systems and projects, as applicable.
- Perform tracking of safety related changes to the CDS for Regulatory Affairs Milestones; includes follow-up with stakeholders where relevant.
- Support creation of safety label change quarterly and annual compliance reports for headquarter functions (RA-QA), Country Pharma Organizations (CPO) and relevant boards (PSB, GLC) Identify and escalate delays and noncompliance with the implementation of safety label changes
- Support and contribute to a compliance and quality culture within the framework of the Safety Label Change Implementation processes and provide assistance, as required, during audits/inspections
- Provide input on Global Labeling systems and processes; including improving current processes to support Global Labeling business Serve as business contact for HQ-Global Labeling and CPO end-users for relevant labeling systems (e.g., iMedidata, SAS program) Provide input for preparation of manuals and training materials as appropriate for labeling systems