Scientific Program Manager RSSP

The Senior Regulatory Affairs Manager serves as a regulatory affairs subject matter expert responsible for managing an Investigational New Drug (IND) application portfolio consisting of vaccines and monoclonal antibodies. This role provides strategic regulatory leadership throughout the product development lifecycle, ensuring compliance with FDA regulations and applicable international regulatory requirements.

The position supports the advancement of investigational products into clinical development by providing regulatory guidance, overseeing submissions, managing compliance activities, and serving as a key liaison among scientific, clinical, manufacturing, and regulatory stakeholders., Regulatory Strategy & Leadership

• Serve as the regulatory affairs expert for vaccine and monoclonal antibody development programs.
• Develop and implement regulatory strategies to support product development and clinical advancement.
• Provide recommendations to leadership on optimal regulatory pathways and product development strategies.
• Evaluate emerging regulations and changing regulatory landscapes for potential impacts on development programs.
• Provide strategic regulatory guidance and risk mitigation recommendations.

IND Management & Regulatory Submissions

• Manage the complete lifecycle of Investigational New Drug (IND) applications and amendments.
• Prepare, write, review, and edit:
• Initial IND submissions
• IND amendments
• FDA Annual Reports
• Investigator Brochures
• Regulatory correspondence
• Ensure compliance with FDA and international regulatory requirements.
• Maintain regulatory documentation and submission records.

FDA & Regulatory Agency Interactions

• Serve as the primary point of contact with FDA project managers.
• Coordinate and lead:
• Pre-Pre-IND meetings
• Pre-IND meetings
• Regulatory strategy meetings
• Prepare meeting packages and supporting documentation.
• Respond to FDA information requests, comments, and regulatory queries.
• Support interactions with international regulatory authorities as required.

Clinical & Regulatory Compliance

• Write and review documentation to ensure compliance with:
• Current Good Clinical Practice (cGCP)
• Good Laboratory Practice (GLP)
• Current Good Manufacturing Practice (cGMP)
• Review and evaluate:
• Clinical study protocols
• Informed consent documents
• Chemistry, Manufacturing, and Controls (CMC) documentation
• Nonclinical study reports
• Regulatory submissions
• Ensure all documentation meets regulatory and quality standards.

Scientific Program Management

• Develop and assist staff in implementing policies and procedures related to scientific programs.
• Collect, analyze, and interpret scientific and regulatory information.
• Evaluate existing scientific programs and recommend improvements.
• Assist in developing and proposing new scientific initiatives.
• Coordinate scientific workshops and prepare outcome reports.

Product Development Support

• Serve as the regulatory representative on product development teams.
• Collaborate with internal and external stakeholders throughout product development activities.
• Support vaccine and therapeutic product advancement from research through clinical development.
• Conduct literature reviews and product assessments to support regulatory strategy.

Regulatory Intelligence

• Monitor and analyze:
• FDA guidance documents
• Regulatory trends
• Industry developments
• Publicly available regulatory information
• Provide regulatory intelligence to support decision-making and risk management.
• Communicate emerging regulatory requirements to stakeholders.

Sponsor Oversight & Reporting

• Prepare detailed reports for executive leadership to ensure Sponsor responsibilities are fulfilled.
• Monitor and support:
• Clinical monitoring plans
• Protocol compliance
• Product accountability
• Human subject safety
• Data integrity
• Regulatory compliance
• Ensure proper oversight of clinical development activities.

Stakeholder Collaboration & Communication

• Serve as liaison between the office and organizations involved in product development.
• Coordinate with:
• Clinical teams
• Research teams
• Manufacturing groups
• Regulatory authorities
• External collaborators
• Licensing partners
• Support regulatory compliance education and training initiatives.

Data Management & Document Control

• Manage complex systems for:
• Regulatory document control
• Data management
• Information dissemination
• Support communications regarding:
• Vaccine clinical trials
• Monoclonal antibody studies
• Collaborative development programs
• Respond to inquiries from:
• Clinical sites
• Sponsors
• FDA representatives
• International regulatory agencies

Public Health & Emergency Response

• Support rapid regulatory response efforts during infectious disease outbreaks and pandemics.
• Contribute to mission-critical vaccine and therapeutic development initiatives.
• Assist in advancing public health preparedness and response objectives., * Regulatory Affairs
• FDA Regulatory Compliance
• Investigational New Drug (IND) Applications
• Vaccine Development
• Monoclonal Antibody Development
• Clinical Research Compliance
• cGCP, GLP & cGMP
• Regulatory Strategy
• Regulatory Intelligence
• FDA Interactions
• Pre-IND Meetings
• Clinical Trial Oversight
• Human Subjects Protection
• Scientific & Technical Writing
• Chemistry, Manufacturing & Controls (CMC)
• Risk Assessment & Mitigation
• Product Development
• Strategic Planning
• Project Management
• Regulatory Documentation
• Data Management & Document Control
• Stakeholder Management
• Public Health & Pandemic Response
• Cross-Functional Leadership

• Master’s Degree in:
• Regulatory Affairs
• Life Sciences
• Biological Sciences
• Public Health
• Pharmacy
• Biomedical Sciences
• Related Scientific Discipline

Experience

• Minimum 8-10 years of regulatory affairs experience supporting the early development of vaccines, biologics, or therapeutics intended for human use.
• Extensive experience managing IND submissions and regulatory compliance activities.
• Experience interacting directly with FDA and other regulatory authorities.

Required Knowledge, Skills & AbilitiesRegulatory Expertise

• Expert knowledge of:
• FDA regulations
• IND application processes
• Clinical trial regulations
• Human subject protection requirements
• Regulatory compliance frameworks
• International regulatory requirements
• Strong understanding of:
• cGCP
• GLP
• cGMP
• CMC documentation

Strategic & Analytical Skills

• Ability to analyze, interpret, and apply complex regulatory requirements.
• Experience developing regulatory strategies and risk mitigation plans.
• Strong policy analysis and strategic planning capabilities.

Communication & Presentation Skills

• Exceptional verbal and written communication skills.
• Ability to prepare and present highly technical and complex information.
• Experience presenting to:
• Senior leadership
• Government officials
• Scientific communities
• Regulatory authorities
• Public stakeholders
• Ability to communicate effectively with diverse audiences and stakeholders.

Project & Program Management

• Strong project management and organizational skills.
• Ability to manage multiple complex regulatory programs simultaneously.
• Experience coordinating cross-functional teams and regulatory initiatives.

Technical Competencies

• Scientific and technical writing expertise.
• Regulatory submission preparation and management.
• Literature review and scientific analysis.
• Clinical research oversight and compliance management.
• Data management and document control systems., * Experience with vaccine development programs.
• Experience with monoclonal antibody development.
• Experience supporting government-sponsored research programs.
• Knowledge of infectious disease research and pandemic response initiatives.
• Experience working with licensing partners and external collaborators.
• Familiarity with global regulatory frameworks and international submissions.

$110,000 - $130,000 a year - Full-time, Contract

22nd Century Technologies, Inc., is one of the fastest-growing IT Service Integrator and Workforce Solution companies in the United States. Founded in 1997, 22nd Century Technologies is a Certified National Minority Business Enterprise with 6,000+ people including 600+ Cyber SMEs nationwide supporting our customers in all 50 states, Canada, and Mexico. With HQs in Somerset, NJ and Mclean, VA, 22nd Century has 14 offices throughout the United States. As part of our unrelenting focus on quality and compliance, 22nd Century Technologies’ delivery is based on Certified Matured Processes including CMMI L3 Dev & SVC, ISO 20000, ISO 27001, and ISO 9001 quality processes. With a strong focus on the public sector, 22nd Century currently holds government contracts with 14 out of 15 Federal Executive agencies including DoD, 37 other Federal agencies, 50 States, 115+ Local agencies, and 37 School Districts. In the last three years, we have expanded our services to Fortune 500 and other commercial clients and currently support 80+ commercial clients.

Recognized among “Best Company to Work For” by Forbes, 22nd Century Technologies, Inc., consistently exceeds our clients’ expectations by focusing on their absolute satisfaction with jobs while keeping our employees motivated.