Senior Specialist, Regulatory Affairs | US Biologicals

Role Summary

At our company, we are dedicated to advancing the prevention and treatment of diseases in both people and animals through innovative health solutions. As a Senior Specialist in Regulatory Affairs for US Biologicals, you will play a crucial role in ensuring our animal health products meet regulatory standards. Join us in our mission to use leading-edge science to save and improve lives around the world.

Responsibilities

• Ensure regulatory filings of animal health products comply with applicable USDA regulations.
• Provide USDA regulatory guidance and strategy with interdepartmental teams for pre and post-license activities of US Biologicals.
• Assist as an Alternate Liaison with the USDA for pre or post-regulatory responsibilities, including submissions and communications.
• Serve as a subject matter expert in regulatory matters such as labeling, facility documents, relative potency assays, antigen overages, licensure processes, permits, and ingredients of animal origin.
• Represent the company's Animal Health division on working groups as defined by the Animal Health Institute.
• Review, prepare, and communicate regulatory submissions in support of new licenses or licensed biologicals with the USDA.
• Serve as the point of contact for GRA international dossier/registration questions for new submissions, renewals, and variations for US Biologicals filed with local CORA.
• Lead the creation of GRA standard international dossiers for US Biologicals.
• Review market advertising and promotions (A&P) for US biologicals to ensure compliance with USDA regulations and product license filings.
• Prepare and maintain regulatory documents and communications regarding US biological restricted products with US state veterinarians for approval and compliance.
• Support state registrations for US biologicals.

Qualifications

• Required: Bachelor's degree in scientific or related areas of study with five years of regulatory experience, or a Master's degree with three years of regulatory experience.
• Required: Knowledge of USDA requirements and regulations relating to the manufacturing and research and development of biological vaccines.
• Required: Effective time and project management skills.
• Required: Strong people, communication, and leadership skills for involvement with cross-departmental teams.
• Preferred: Prior experience in the vaccine, pharmaceuticals, or biological industry.

Skills

• Accountability
• Adaptability
• Assay
• Audits Compliance
• Biochemical Assays
• Biopharmaceutical Industry
• Biosecurity
• Detail-Oriented
• Documentations
• Drug Regulatory Affairs
• Employee Training Programs
• Global Communications
• Licensing Law
• Manufacturing Compliance
• Mentorship
• Pharmaceutical Regulatory Affairs
• Pharmacovigilance
• Process Improvements
• Project Management
• Regulations
• Regulatory Affairs Management
• Regulatory Compliance
• Regulatory Operations
• Regulatory Strategy Development

Additional Requirements

• Location: United States (US and Puerto Rico residents only)
• Travel Requirements: 10%
• Working arrangement: Hybrid in the US (three on-site days per week, Monday–Thursday, with Friday remote)