Industry Regulatory Affairs
FT-Days
REMOTE OPTION
$70,000 - $95,000
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.
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.
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