Senior Regulatory Affairs Manager

🕒 June 5

🌪️ Kansas – Remote

🌪️ Kansas – Remote

⏰ Full Time

🟠 Senior

🚔 Compliance

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Argenta

WebsiteLinkedInAll Job Openings

501 - 1000 employees

Founded 2006

🧬 Biotechnology

💊 Pharmaceuticals

🔬 Science

💰 $30M Private Equity Round on 2021-05

Biotechnology • Pharmaceuticals • Science

Argenta is a global contract research, development, and manufacturing organization (CRO/CDMO) focused exclusively on animal health. They provide comprehensive services from drug development to regulatory and clinical services to manufacturing, employing a 'molecule to market' approach. Argenta partners with companies worldwide to develop and bring animal health pharmaceuticals and products to market. Their expertise includes regulatory guidance, clinical studies, and manufacturing support, delivering over a billion doses of animal health medicines annually. With a large team of scientists, veterinarians, and consultants and multiple EMA and FDA-approved manufacturing locations, Argenta is dedicated to advancing animal health through innovation, including the development of novel therapies like monoclonal antibodies and stem cells.

📋 Description

• 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

🎯 Requirements

• Bachelor’s degree or equivalent experience in a scientific discipline, advanced degree (DVM, PhD, MS) is preferred • 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 • Development and regulatory experience with food animal drugs is preferred but not required • 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 • 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.

🏖️ Benefits

• Remote position • Domestic and occasionally international travel flexibility