Vaccinex is a clinical-stage biotechnology company engaged in the discovery and development of targeted biotherapeutics to treat serious diseases with unmet medical needs, including neurodegenerative diseases, cancer and autoimmune disorders. We believe we are the leader in the field of semaphorin 4D (SEMA4D) biology, and that we are the only company evaluating SEMA4D blockade as a potential treatment for neurodegenerative diseases, cancer or autoimmune disorders. Vaccinex has also developed a proprietary antibody discovery platform, ActivMab®, that enables efficient mammalian cell based expression of a library of human antibodies using viral vectors. In addition, this fusion protein technology enables the direct incorporation of conformation-dependent multipass membrane proteins, such as GPCRs and ion channels, into the viral membrane.
The Senior Regulatory Affairs Associate is responsible for assisting in the planning for and preparation of various documents for submission to regulatory agencies (eg FDA, Health Canada), including IND safety reports, protocol amendments, IND annual reports, CMC and stability update documents, etc. Additionally, this individual will perform quality reviews of all submission documents to ensure compliance with the regulatory agency submission guidelines. This individual will also work with document authors to correct deficiencies in documents not meeting submission guidelines. Finally, this individual will work with the Manager Quality Systems to prepare the necessary SOPs and other process documents to fully describe processes involved in the preparation, review and submission of various regulatory documents.
- Assist in the planning, preparation, review and submission of documents to the FDA and to other regulatory agencies in eCTD format.
- Ensure that regulatory submissions are efficiently reviewed, approved, and processed.
- Remain up-to-date on U.S., Health Canada regulatory requirements and FDA/ICH guidance, and interpret and apply the regulations and guidance to Vaccinex submissions.
- Work with the Manager, Quality Systems to conduct due diligence and regulatory compliance audits of any contractors and vendors involved in the submission of regulatory documents.
- Assist in maintaining regulatory files in support of Vaccinex regulatory agency submissions.
- Review technical/regulatory/clinical documentation related to BLAs, or other applications, as assigned, to support original submissions, amendments, supplements and annual reports.
- B.S./B.A. degree or higher in biological or physical sciences. MS degree in Regulatory Affairs preferred.
- At least three (3) or more years in the bio/pharmaceutical industry, including at least 2 years in a regulatory document publishing role. Experience with electronic submissions in the eCTD format; experience with eCTD software preferred. Good computer skills and experience using MS Word, Excel and Access, and Adobe Acrobat also required.
- Scientific technical background with an emphasis on skills and know-how related to the manufacture, laboratory testing, and release of therapeutic monoclonal antibodies in the bio/pharmaceutical industry.
- Evidence demonstrating superior attention to details.
- Good interpersonal and team skills; ability to manage multiple initiatives and projects simultaneously and in accordance with stipulated timelines.
- Excellent written and oral communication skills; ability to work independently and as a team member.
- Working knowledge of FDA regulations related to submissions activities, in particular in regard to IND safety reporting.
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.
Please send resume via e-mail to email@example.com.