Senior Regulatory Affairs Manager

3 days ago

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Argenta

WebsiteLinkedInAll Job Openings

animal health • product development • veterinary pharma • contract manufacturing • contract research

501 - 1000

💰 $30M Private Equity Round on 2021-05

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 • 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.