Argenta

Senior Regulatory Affairs Manager

Argenta

full-time

Posted on:

Location Type: Remote

Location: Kansas • United States

Visit company website

Explore more

✨ AI Apply
Apply

Job Level

Senior

Tech Stack

Google Cloud Platform

About the role

  • 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
  • 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.
Benefits
  • Health insurance
  • Travel allowances
  • Flexible work arrangements
  • Domestic and international travel opportunities
  • Professional development opportunities

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard skills
regulatory processesanimal drug developmentCVME-SubmitterGLPGCPGMPUSDAEPAEMA
Soft skills
written communicationoral communicationcollaborationanalytical skillsattention to detailinfluencenegotiationpersuasionprioritizationflexibility
Certifications
Bachelor’s degreeDVMPhDMS