Hybrid Senior Specialist – Regulatory Affairs

at MSD

• Job title: Senior Specialist – Regulatory Affairs
• Job type: Full Time
• Experience level: Senior
• Salary: $104,200 - $163,900 per year
• Degree requirement: Bachelor's Degree
• Location requirements: Hybrid, United States

About the role

• Ensure regulatory filings of animal health products meet USDA regulations while collaborating with global teams in veterinary pharmaceutical industry.

Responsibilities

• This position is responsible for ensuring regulatory filings of animal health products in pursuance of licensure and marketed animal health products are submitted in compliance with applicable USDA regulations and is within the Global Regulatory Affairs Bio team.
• In this role, you participate in cross functional teams on maintenance of our products to provide support/drive filings for marketed animal health products in compliance with applicable USDA regulations and regulations for relevant export regions.
• Provide USDA regulatory guidance and regulatory strategy with interdepartmental teams for pre and post license of US Biologicals.
• Additionally, may assist as an Alternate Liaison with the USDA for pre or post-regulatory responsibilities to include submissions and communications with the USDA, internal MAH departments or international permittees, where applicable.
• May serve as subject matter expert in regulatory matter(s), such as but not limited to labeling, facility documents, relative Potency assays, antigen overages, licensure processes, permits, ingredients of animal origin and ensure that these meet the requirements of the USDA and export markets.
• Develops and maintains profound knowledge of all relevant regulatory requirements.
• Review, prepare and communicate regulatory submissions in support of new licenses or licensed biologicals with the USDA.

Requirements

• Bachelor’s degree with a minimum of 5 years of regulatory experience, or Master’s degree with a minimum of 3 years of regulatory experience in the vaccine industry
• Minimum of (regulatory) experience within the (veterinary) pharmaceutical industry (preferable biologicals)
• Preferred working knowledge of USDA requirements and regulations relating to manufacturing of biological vaccines
• Excellent time and project management skills
• Excellent people, communication, leadership skills and well-developed cultural awareness for involvement with cross departmental teams

Benefits

• medical
• dental
• vision healthcare and other insurance benefits (for employee and family)
• retirement benefits, including 401(k)
• paid holidays
• vacation
• compassionate and sick days