Coordinator of Regulatory Affairs

Website Genvax Technologies, Inc.

Genvax Technologies is a startup livestock vaccine company located in Ames, Iowa. We have a dynamic team of experienced scientists and entrepreneurs poised to develop next generation mRNA + nanoparticle vaccines. This isn’t the first go-around for co-founders Joel Harris and Dr. Hank Harris, who successfully created, grew and sold Harrisvaccines to Merck Animal Health in 2015. We are looking for those who aren’t afraid to wear many hats at Genvax and will accept challenges to grow professionally along the way. If you are looking for progressive technology coupled with modern culture and aren’t afraid of a challenge, this may be the place for you.

Position Overview:

Genvax Technologies seeks a Coordinator of Regulatory Affairs to initiate and follow-up on USDA Center for Veterinary Biologics (USDA-CVB) 9 CFR and Veterinary Service (VS) memorandum correspondence regarding both product licensures and facility licensure for livestock vaccines. The coordinator will be responsible for accurate and timely submission of all required correspondence and building strong rapport with the USDA-CVB.

Essential Job Functions:

-Write and submit Outlines of Production
-Manage portal for Web-based submissions to CVB
-Initiate regulatory interactions for USDA licensure of vaccine products
-Ensures all USDA approved documents are updated as needed
-Coordinate with Genvax research scientists and SAB members to obtain accurate information and compliance with regulatory guidelines
-All other tasks as needed by the Company

Requirements
-B.S. with 2-3 years of experience or M.S. with 1 year of experience in animal vaccines
-Familiar with 9 CFR and VS Memorandums as relates to animal vaccine production
-Familiar with facility and vaccine-specific USDA licensure documentation requirements
-Familiar with Manufacturing and Q.A. methods and procedures
-Experience in USDA/CVB regulatory documentation for vaccine licensure highly desirable
-Experience in USDA facility licensure highly desirable
-Experience or training in Good Manufacturing Practices highly desirable

Organizational Relationships:

-Reports to Chief of Staff and Facilities

Additional Notes:

-Potential opportunity to participate in Equity Incentive plan.

-It is the policy of Genvax Technologies to provide equal employment opportunities without regard to race, color, religion, sex, national origin, age, disability, marital status, veteran status, sexual orientation, genetic information or any other protected characteristic under applicable law. This policy relates to all phases of employment, including, but not limited to, recruiting, employment, placement, promotion, transfer, demotion, reduction of workforce and termination, rates of pay or other forms of compensation, selection for training, the use of all facilities, and participation in all company-sponsored employee activities.

-Applicants must be authorized to work for ANY employer in the US. We are unable to sponsor or take over sponsorship of employment Visa at this time.

-The Coordinator of Regulatory Affairs must be able to perform the essential functions of the position satisfactorily and, if requested, reasonable accommodations will be made to enable employees with disabilities to perform the essential functions of their job, absent undue hardship.

To apply for this job please visit apply.workable.com.