Regulatory Affairs Specialist

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.