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Regulatory Affairs Manager - Lincoln, United States - HUVEPHARMA, INC
Description
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.
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.
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.
Negotiates and influences internal personnel and regulatory agencies (national and international) as needed to resolve key regulatory issues and expedite approvals of products.
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