Regulatory Affairs Specialist

• 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. • Excellent oral andwritten communication skills, including

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. • Excellent oral andwritten communication skills, including the ability to assist with thepreparation of responses to health authority requests • Strong proficiency withMicrosoft Office suite including Word, Excel, and Power Point as well as AdobeAcrobat ·Creativity andproblem-solving skills ·Good organizational andplanning skills. • Demonstrated ability toidentify issues and take appropriate actions. • The ability to build andmaintain professional relationships with management, peers, and subordinates. ·Attention to detailrequired. Originally posted on Himalayas Regulatory-Affairs-Specialist, Regulatory-Affairs, Regulatory-Compliance-Specialist, Regulatory-Specialist, Regulatory-Affairs-Associate, Regulatory-Affairs-Analyst, Regulatory-Affairs-Coordinator, Regulatory-Affairs-Specialist-II