Description

The Regulatory Affairs Associate – Document Management Systems, is responsible for executing tasks related to maintaining and managing electronic documents, records, and data bases in support of regulatory submissions; assisting in interpreting federal regulations and analyzing their impact on assigned projects; assisting in interpreting and evaluating data and documentation intended for submission to the FDA; assisting in planning and implementing assigned regulatory submissions; and assisting in the maintenance and management of regulatory documentation and records in support of Vaccinex applications.

Responsibilities

1. Maintain an electronic documentation management system (DMS) compliant with FDA regulations and expectations, building on the existing Vaccinex system
2. Manage update of existing electronic DMS and implement new systems as required
3. Manage SOPs for use of the document system, including procedures for change control, deviation management and computer system change control.
4. Conduct periodic review of SOPs and other documents to ensure they are current
5. Train personnel in the use of the document control system and assist in the generation of SOPs by Vaccinex personnel
6. Maintain and control access to the archive of all documents and records as required in an FDA-regulated environment
7. Maintain various quality systems and regulatory databases such as document change control
8. Track and review equipment logbooks, calibration and maintenance logs, etc.
9. Ensure the timely review and approval of controlled documents by tracking and coordinating the review process in a proactive fashion
10. Maintain a records management system compliant with cGMP, GLP, and GCP regulations and expectations building on the existing Vaccinex system
11. Maintain training programs and training records
12. Assist in the planning and implementation of submissions to the FDA in the electronic eCTD format.
13. Assist in the preparation of documents for electronic submission including defining submission structure, applying naming conventions and editorial conventions in keeping with the Vaccinex Style Guide.
14. Participate in review of submission documentation for completeness and compliance with applicable regulations and guidance documents.
15. Interface with publishing staff to ensure submissions are efficiently reviewed, approved, and processed.
16. Remain up-to-date on U.S. regulatory requirements and FDA/ICH guidance, and interpret and apply the regulations and guidance to Vaccinex submissions.
17. Assist in identifying FDA/ICH guidance designed to support compliance with cGMP, GLP and GCP regulations.
18. Maintain information about Vaccinex clinical trials in the ClinicalTrials.gov system

Qualifications

1. BS/BA degree in biological or physical sciences, or equivalent combination of education and experience, is required
2. At least 5 years in the regulated bio/pharmaceutical industry and at least 3 years hands-on experience with document management is required
3. Previous direct experience in Regulatory Affairs and/or Quality Systems and/or electronic submissions in the eCTD format is strongly preferred
4. Scientific technical background with an emphasis on skills and know-how related to the manufacture, laboratory testing, and release of therapeutic biologic products (e.g., therapeutic monoclonal antibodies, vaccines) in the biopharmaceutical industry is strongly preferred
5. Excellent attention to detail is a must have
6. Strong interpersonal and team skills; ability to manage multiple initiatives and projects simultaneously is required
7. Excellent written and oral communication skills; ability to work independently and as a team member; demonstrated strong leadership skills is required
8. Must be competent in computer programs such as Microsoft Word, Microsoft Excel, Microsoft PowerPoint; experience with EDMS software is strongly preferred
9. Solid knowledge of FDA regulations related to submissions activities, in particular in regard to Investigational New Drug applications (21CFR Part 312)
10. Familiarity with computer system validation and change control is strongly preferred

Please submit a cover letter and resume with the subject line “Regulatory Affairs Associate”

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Cover Letter and Resume as Word or PDF file (required)

 

Please Note: Due to the high volume of responses, only inquiries from qualified candidates can be addressed.

No telephone inquiries or recruiters, please.

Vaccinex, Inc. is an equal opportunity employer.