Manager – Biologics Regulatory Affairs

MS or higher in veterinary medicine, biologics, infectious diseases, immunology, or a related field.
A minimum of 5 years’ experience with veterinary biological products, preferably in regulatory affairs or a related area.
Strong interpersonal and communication skills, must demonstrate ability to work in a team environment.
Understanding of the veterinary biological development process and USDA regulatory requirements preferred.
Experience in working with production and testing of veterinary biological products would be advantageous.
Being comfortable with standard software (Excel, etc.) and communication technologies.

Serve as member on multidisciplinary project teams responsible for developing veterinary biological and biopharmaceutical products, develop regulatory strategy for project teams, and be responsible for all US regulatory reviews, preparation and submissions for assigned projects with high level of autonomy.
As regulatory liaison for project teams, develop and maintain effective relationship with USDA assigned reviewers and personnel.
Serve as a regulatory advisor in early lead seeking and research phase projects to provide timely input and direction for teams.
Liaise with Global Commercial Development and Global Biologics teams to develop and negotiate label claims and product supporting materials.
Liaise closely in the regions to facilitate global registration where appropriate.
Provide regulatory support of biological product labeling, advertisement, and promotional materials.
Provide regulatory support to internal regulatory group processes and systems when needed for unlicensed and licensed products.
Influence and contribute towards industry associations and on internal committees.

Understanding of the veterinary biological development process and USDA regulatory requirements preferred.
Familiarity with molecular biology and/or cell biology techniques desirable.