Senior Specialist, Regulatory Affairs | US Biologicals

Job Description

Senior Specialist, Regulatory Affairs | US Biologicals

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.

• Knowledge of USDA requirements and regulations relating to the manufacturing and research and development of biological vaccines.

• Effective time and project management skills.

• Strong people, communication, and leadership skills for involvement with cross-departmental teams.

Preferred

• Prior experience in the vaccine, pharmaceuticals, or biological industry.

Required Skills:

Accountability, 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 {+ 4 more}

Preferred Skills:

Current Employees apply HERE

Current Contingent Workers apply HERE

US and Puerto Rico Residents Only:

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