Regulatory Affairs Specialist jobs in Lincoln, NE

Provides extensive knowledge to ensure regulatory approvals in the US for veterinary biologicals and to ensure global registrations for veterinary biologicals are completed in accordance with the corporate strategy. Works on highly complex projects without supervision and assists less-experienced staff to perform critical functions within the department.

EDUCATION AND EXPERIENCE

• Bachelor’s degree required, Master’s Degree preferred, in Biology, Microbiology, or similar life sciences
• 10-14 years’ relevant regulatory experience in either the veterinary biopharmaceutical or biologicals industry
• More than 5 years’ leadership and project management experience
• Established relationship with USDA CVB preferred

TECHNICAL SKILLS REQUIREMENTS

• Extensive knowledge of regulatory agencies and their mandates for approval of veterinary biological products in the US and other countries
• Strong scientific and technical understanding of R&D processes, product development and licensing
• Strong understanding of manufacturing and quality requirements, processes and compliance
• Outstanding written and verbal communication skills, such as the need to understand, review and comment on scientific datasets, methods, and reports
• Effectively collaborates, influences and builds trust across multiple disciplines and levels of the company
• Strong positive negotiation skills
• Strong project management and priority-setting skills
• Ability to identify and resolve issues timely and pro-actively

PHYSICAL REQUIREMENTS

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of the job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job, the employee sits most of the time. Ability to travel to various sites and to government meetings as required.

POSITION RESPONSIBILITIES

• Accountable for the timely creation, preparation and submission of registration documentation required for approval of new biological products in the US.
• Accountable for the timely creation, preparation and submission of registration documentation required to ensure compliance to 9CFR regulations for all biological products.
• Provide technical, strategic and tactical regulatory guidance to project teams and staff for development of new products and maintenance of existing products.
• Communicates pertinent changes and updates to applicable project teams and senior management.
• Negotiates and influences internal personnel and regulatory agencies (national and international) as needed to resolve key regulatory issues and expedite approvals of products.
• Effectively participate with industry trade associations.