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Job Description
Scientific Program Manager RSSP 22nd Century Technologies, Inc. - 3.7 Bethesda, MD Job Details Full-time | Contract $110,000 - $130,000 a year 21 hours ago Qualifications FDA submissions Medical writing Managerial strategic planning Teamwork Content creation for technical audiences Research ethical considerations Interpersonal skills Document control experience within pharmaceutical industry Clinical trial risk management Data analysis skills Collaborating with government agencies Investigational new drug (IND) applications Master's degree Organizational skills Leading team collaboration initiatives Chemistry, manufacturing & controls Presentation preparation Regulatory submission editing and review Biomedical regulatory compliance Communication with regulatory authorities for clinical trials Managing projects Clinical quality assurance standards GMP for research safety and compliance Clinical program risk management Technical writing experience within technology Project leadership Cross-functional team management Project stakeholder communication Cross-functional communication Medical literature reviews
Full Job Description Employment Type:
Full-Time Position Summary 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. Key Responsibilities 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. Required QualificationsEducation 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. Preferred Qualifications 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. Key Skills Regulatory Affairs FDA Regulatory Compliance Investigational New Drug (IND) Applications Vaccine Development Monoclonal Antibody Development Clinical Research Compliance c
GCP, 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 LI_TSC About our
Company:
- 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. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
