Regulatory Affairs Specialist

Responsibilities in this position will include: · Supports preparation and maintenance of program annual reports, and may support CMC, nonclinical, pharmacovigilance and other routine regulatory programs and other routine regulatory filings. · Conducts internet searches on regulatory topics to support development programs, and department and company compliance. · Provides technical review of data or reports to be incorporated into regulatory submissions to ensure scientific rigor, accuracy, and clarity of presentation. · Coordinates, prepares, or reviews regulatory submissions for domestic and/or international projects. · If supporting a marketed product, reviews product promotional materials and labeling for compliance with applicable regulations and policies. · Communicates with regulatory agencies regarding pre-submission strategies, potential regulatory pathways, as well as clarification and follow-up of submissions under review. · Ensures compliance with applicable regulations and guidelines (e.g., FDA, EMA, ICH). · Interacts with and may have some oversight of vendor/contract research organization activities. · Escorts government inspectors during inspections and provides post-inspection follow-up information as requested. · Interprets regulatory rules or rule changes and ensures they are incorporated into corporate policies and procedures as appropriate. · Assists in writing or updating standard operating procedures, work instructions, or policies. · Advises project teams on subjects such as premarket regulatory requirements, labeling requirements, or clinical study regulatory compliance issues. · Identifies relevant guidance documents, international standards, or consensus standard and provides interpretive assistance. · Participates in internal or external audits. · Reviews clinical protocols to ensure collection of data needed for regulatory submissions. · Coordinates recall or market withdrawal activities as necessary. · Manages regulatory tasks within time and budget of approved project plans. · Qualifications · Bachelor's degree in a related field; advanced degree desirable; RAC certification desirable. · A minimum of two years of relevant experience in Regulatory Affairs with drug or therapeutics biologic products. · Working knowledge of drug development guidelines and FDA regulations. · Familiarity with EMA or other OUS regulatory systems. · Strong organizational skills to maintain a high level of productivity, innovation, and prioritization under tight timelines. · Excellent oral and written communication skills, including the ability to assist with the preparation of responses to health authority requests · Strong proficiency with Microsoft Office suite including Word, Excel, and Power Point as well as Adobe Acrobat · Creativity and problem-solving skills · Good organizational and planning skills. · Demonstrated ability to identify issues and take appropriate actions. · The ability to build and maintain professional relationships with management, peers, and subordinates. · Attention to detail required.