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.