Responsibilities in this position will include:
- Supports preparation andmaintenance of program annual reports, and may support CMC, nonclinical,pharmacovigilance and other routine regulatory programs and other routineregulatory filings.
- Conducts internetsearches on regulatory topics to support development programs, and departmentand company compliance.
- Provides technicalreview of data or reports to be incorporated into regulatory submissions toensure scientific rigor, accuracy, and clarity of presentation.
- Coordinates, prepares,or reviews regulatory submissions for domestic and/or international projects.
- If supporting a marketedproduct, reviews product promotional materials and labeling for compliance withapplicable regulations and policies.
- Communicates withregulatory agencies regarding pre-submission strategies, potential regulatorypathways, as well as clarification and follow-up of submissions underreview.
- Ensures compliance withapplicable regulations and guidelines (e.g., FDA, EMA, ICH).
- Interacts with and mayhave some oversight of vendor/contract research organization activities.
- Escorts governmentinspectors during inspections and provides post-inspection follow-upinformation as requested.
- Interprets regulatoryrules or rule changes and ensures they are incorporated into corporate policiesand procedures as appropriate.
- Assists in writing orupdating standard operating procedures, work instructions, or policies.
- Advises project teams onsubjects such as premarket regulatory requirements, labeling requirements, orclinical study regulatory compliance issues.
