Regulatory Affairs Specialist

About this role

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. Identifies relevantguidance documents, international standards, or consensus standard and providesinterpretive assistance. Participates in internalor external audits. Reviews clinicalprotocols to ensure collection of data needed for regulatory submissions. Coordinates recall ormarket withdrawal activities as necessary.

Manages regulatory taskswithin time and budget of approved project plans. Qualifications Bachelor's degree in arelated field; advanced degree desirable; RAC certification desirable. A minimum of two yearsof relevant experience in Regulatory Affairs with drug or therapeutics biologicproducts. Working knowledge ofdrug development guidelines and FDA regulations. Familiarity with EMA orother OUS regulatory systems. Strong organizationalskills to maintain a high level of productivity, innovation, and prioritizationunder tight timelines.