Manager, US Biologics Regulatory Affairs

States considered: All

Role Description

The position will address veterinary biological product registration needs for the United States. Candidate will be responsible for ensuring that biological, including biopharmaceutical, products are developed, registered, and maintained in compliance with USDA Center for Veterinary Biologics regulatory requirements. Candidate will liaise closely with other US biologics regulatory staff to facilitate US registrations consistent with the company portfolio plan. Candidate will also connect with international regulatory staff to facilitate global registration where appropriate. Candidate will represent regulatory affairs on project teams with the responsibility to align with partner groups and organizations to drive product registrations consistent with approved product profiles.

​Position will be on site, Kalamazoo MI, or remote.

Position Expected Responsibilities

• 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.
• Expected Travel: 5-10%

Education and Experience

• 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.
• Technical Skills Requirements
• Strong interpersonal and communication skills, must demonstrate ability to work in a team environment. An understanding how to influence and diplomatically challenge when needed is highly desirable.
• 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.
• Familiarity with molecular biology and/or cell biology techniques desirable.

The following base pay range reflects the anticipated base pay for this position if a selected candidate were to be located in (Colorado). Base pay may vary based on location and other factors.

Base Pay Range: $91,000 - $131,000

The following base pay range reflects the anticipated base pay for this position if a selected candidate were to be located in (California), (NJ Remote), (NY Remote), or (Washington). Base pay may vary based on location and
other factors.

Base Pay Range: $103,000 - $148,000

[This position is eligible for short-term incentive compensation.] [The position is also eligible for long-term incentives.}

We offer a competitive and comprehensive benefits package, which includes healthcare, dental coverage, and retirement savings benefits along