Senior Regulatory Affairs Manager

This is a fully remote position, open to applicants in Kansas.

📋 Description

• Facilitates and supports the regulatory and drug development needs of both external clients and internal projects.

• Effectively manages client and stakeholder expectations by delivering timely, relevant, and accurate documents, assessments, reports, and communications.

• Demonstrates a strong understanding of current regulations, guidelines, regulatory processes, and the animal drug development landscape, while maintaining a flexible and innovative approach to overcoming regulatory challenges.

• Develops regulatory solutions for intricate issues.

• Offers clients expert regulatory advice regarding animal health product development.

• Represents Argenta in industry associations such as GADA, AHI, and SQA.

• Identifies and seeks new regulatory consulting opportunities, which may involve meeting potential clients, traveling, speaking at professional events, networking within the industry, and contributing to various publications.

⛳️ Requirements

• Bachelor’s degree or equivalent experience in a scientific field; an advanced degree (DVM, PhD, MS) is preferred.

• Over 8 years of experience in veterinary regulatory and/or animal drug development.

• Proven expertise in several areas including CVM, E-Submitter, GLP, GCP, GMP, USDA, EPA, and EMA.

• Experience in the development and regulation of food animal drugs is preferred but not mandatory.

• Strong written and verbal communication skills, with the ability to collaborate effectively within and across teams.

• Results-oriented with a focus on bottom-line outcomes.

• Excellent analytical abilities and meticulous attention to detail.

• Proven skills in influence, negotiation, and persuasion.

• Effectively defines and organizes priorities, comfortable with balancing shifting priorities to meet business requirements.

• This position is subject to a DEA background check after the offer and at regular intervals.

• Completion of a post-offer drug test is also required; both the background and drug tests must meet company standards or employment offers will be rescinded.

🏝️ Benefits

• Remote position.

• Flexibility for domestic and occasional international travel.