Senior Regulatory Affairs Specialist

The Henry M. Jackson Foundation - Rockville, MD (30+ days ago)4.0


Join the HJF Team!

HJF is seeking a Senior Regulatory Affairs Specialist to support the Center for Neuroscience and Regenerative Medicine in Rockville, Maryland. Responsible for managing regulatory strategy and practices, to support CNRM clinical trial portfolio as well as regulatory compliance throughout the Program. HJF provides scientific, technical and programmatic support services for CNRM.

Responsibilities:
Oversees the preparation and filing of submissions to regulatory authorities.
Develop a system to keep track of the progress of these regulatory submissions.
Create and maintain Regulatory Affairs Standard Operating Procedures
Provide regulatory decisions with regard to acceptability for submission documents.
Provide strategic regulatory input and guidance on cross-functional teams.
Provide guidance on risk assessment, and required corrective actions to meet regulatory requirements.
Communicates regulatory policy to research teams and provide clarity on regulatory expectations and timelines.
Interface with partner organizations, consultants, etc. to ensure regulatory issues are satisfactorily met while protecting proprietary information in relation to submission activities.
Utilizes and shares expert knowledge to resolve complex issues; trains and coaches others in regulatory requirements.
Assess and communicate regulatory requirements, ensuring activities are in compliance with applicable regulations and guidelines.
Actively contributes to the development and implementation of regulatory strategy and timelines for assigned projects and programs.
Maintains an active engagement with emerging and current regulatory requirements in various jurisdictions.
Participate in in discussions and negotiations with regulatory authorities, agents, partners and distributers, as required.
Attend continuing education courses to keep current on changing FDA and DoD regulations and policies concerning research involving human subjects.
Completes other projects as needed.

Required Knowledge, Skills, and Abilities:
Superior knowledge of federal and local regulations and policies pertinent to research involving human subjects. Significant knowledge of clinical and outcomes research study design, Good Clinical Practices, and global clinical regulations.
Excellent communication, interpersonal and organizational skills; ability to utilize computer applications packages, such as MS Word, Excel, PowerPoint, Access and E-mail.
Ability to work and manage multiple projects in a clinical research environment and meet expected goals and objectives with minimal supervision.
Minimum Education/Training Requirements: Bachelor’s degree in a scientific discipline or a related field is desired. Must have completed training in human subjects protection in research.

Minimum Experience: 4 - 6 years-related experience in the area of human use research and clinical trials. Previous experience in a medical or scientific environment, FDA regulated research and DoD or VA funded research preferred.

Physical Capabilities: Must be able to utilize computer for lengthy periods of time; perform routine filing; must be able to travel to research sites occasionally.

Required Licenses, Certification or Registration: RAPS certification preferred.

Work Environment: Office environment. Domestic travel can be anticipated about 20% of the time.

Background: Eligible to obtain a Common Access Card (CAC) background.

HJF is an equal opportunity and affirmative action employer. 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.

Any qualifications to be considered as equivalents, in lieu of stated minimums, require the prior approval of the Chief Human Resources Officer.