Senior Regulatory Affairs Consultant - Medasource

Sr. Regulatory Affairs Specialist

3+ Month Contract

ASAP

100% Remote, but prefers local to Houston, TX

Summary

The Senior Regulatory Affairs Specialist is responsible for leading and coordinating entire regulatory submission filings of both investigational and marketed products utilized at our Client for patient care and research activities. This includes developing regulatory strategy for individual investigational products that are in development and communication of those plans to cross functional team members throughout the organization. This is responsible for end-to-end compiling of information needed to support both investigational and marketing applications to Food and Drug Administration (FDA) and other relevant Health Authorities. Responsible in initial filings of application and maintaining compliance reporting and maintaining regulatory approvals from applicable Health Authorities. This position will interface with the FDA and other applicable Health Authorities. Performs administrative duties required for direct supervision of Regulatory Affairs personnel and support staff.

EDUCATION REQUIREMENTS

• Bachelor's degree in life sciences or related field
• Master’s degree preferred

EXPERIENCE REQUIREMENTS

• Six years of Regulatory Affairs experience within an FDA regulated industry, preferably devices, diagnostics, or pharmaceuticals and/or within an academic medical center setting that routinely requires investigational or marketing submissions to FDA or similar Health Authorities.
• Experience of successful submission of applications to Health Authority including Investigational Drug, Device (IND/IDE) compassionate use, pre-submission requests, market applications
• Experience filing with IND/IDE, from academic setting with investigator qualities such as filing investigator access use

CERTIFICATIONS, LICENSES AND REGISTRATIONS REQUIRED

• Regulatory Affairs Certification (RAC) preferred
• CCRC (Certified Clinical Research Coordinator) preferred
• CCRA (Certified Clinical Research Associate) or ACRP-CP (Association of Research Professionals-Certified Professional) preferred

KNOWLEDGE, SKILLS AND ABILITIES REQUIRED

• Demonstrates the skills and competencies necessary to safely perform the assigned job, determined through on-going skills, competency assessments, and performance evaluations
• Sufficient proficiency in speaking, reading, and writing the English language necessary to perform the essential functions of this job, especially with regard to activities impacting patient or employee safety or security.
• Ability to effectively communicate with patients, physicians, family members and coworkers in a manner consistent with a customer service focus and application of positive language principles.
• Demonstrated knowledge and applied expertise in IND/IDE processes.
• Skilled at managing multiple projects with conflicting priorities.
• Excellent communication and interpersonal skills.
• Proficient in MS Office products (Word, Excel, PowerPoint, Outlook, Project).
• Working knowledge of US regulations and guidance including but not limited to FDA 21 Code of Federal Regulations.