Senior Regulatory Affairs Manager

Argenta • Shawnee, KS

1d • Remote

About The Position

Argenta is currently looking to fill the role of Senior Regulatory Affairs Manager within our CRO Americas division. This role facilitates and supports the regulatory and drug development requirements of external clients and internal projects. The successful candidate will effectively manage client and stakeholder expectations by providing timely, relevant, and accurate documents, assessments, reports, and communications. They will demonstrate an awareness of current regulations, guidance, regulatory processes, and the animal drug development process, while maintaining a flexible and creative mindset to work through regulatory challenges. This role involves creating regulatory solutions to complex issues, providing clients with accurate expert regulatory advice on animal health product development, and representing Argenta in industry associations (e.g., GADA, AHI, SQA). Additionally, the Senior Regulatory Affairs Manager will identify and pursue new regulatory consulting opportunities, which may include meeting with new clients, traveling and speaking at professional meetings, networking in the industry, and contributing to various publications.

Requirements

• Bachelor’s degree or equivalent experience in a scientific discipline
• 8+ years experience in veterinary regulatory and/or animal drug development
• Proven experience includes several of the following: CVM, E-Submitter, GLP, GCP, GMP, USDA, EPA, EMA
• Good written and oral communication skills, and ability to work collaboratively within and across teams
• Results and bottom line oriented
• Excellent analytical skills and attention to detail
• Proven influence, negotiation and persuasion skills
• Defines and plans priorities well. Comfortable balancing shifting priorities as required to meet business needs
• Must be aligned with company values of "We are Doers, We are Team Players, We are Innovators, We are Customer-Centric"

Nice To Haves

• Advanced degree (DVM, PhD, MS) is preferred
• Development and regulatory experience with food animal drugs is preferred but not required

Responsibilities

• Facilitates and supports the regulatory and drug development requirements of external clients and internal projects
• Effectively manage client and stakeholder expectations by providing timely, relevant, and accurate documents, assessments, reports and communications
• Demonstrates an awareness of current regulations, guidance's, regulatory processes, and the animal drug development process, while maintaining a flexible and creative mindset to work through regulatory challenges
• Creates regulatory solutions to complex issues
• Provides client accurate expert regulatory advice on animal health product development
• Represent Argenta in industry associations (e.g. GADA, AHI, SQA)
• Identify and pursue new regulatory consulting opportunities which may include meeting with new clients, traveling and speaking at professional meetings, networking in the industry and contributing to various publications

Benefits

• This position is subject to a DEA background check post offer and at regular intervals.
• This position is also required to complete a post offer drug test.
• Both the background and drug test must comply with company standards or offers of employment will be rescinded.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior