Job Details

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.