Sr. Specialist, Regulatory Affairs

Sr. Specialist, Regulatory Affairs


As a member of the Regulatory Affairs Biologics team, the Senior Specialist is responsible but is not limited to the following duties:

  • Provide USDA regulatory guidance and regulatory strategy with interdepartmental teams for pre and post license of US Biologicals.
  • Review, prepare and communicate regulatory submissions in support of new licenses or licensed biologicals with the USDA. Alternatively, may review and prepare registration documents for export markets.
  • Review market advertising and promotions for US biologicals in compliance with USDA regulations.
  • Prepare and maintain regulatory documents and communications regarding US biological products with local and federal agencies.

Education: Minimum Requirements

  • Bachelor’s degree with at least 5 years of regulatory experience, or Master’s degree with a minimum of 3 years of regulatory experience in the vaccine or pharmaceutical industry.
  • Knowledge of USDA requirements and regulations relating to manufacturing and research and development of biological vaccines.  Excellent time and project management skills.  Excellent people, communication and leadership skills for involvement with cross departmental teams.

We are a research-driven biopharmaceutical company. Our mission is built on the simple premise that if we “follow the science” that great medicines can make a significant impact to our world. We believe that a research-driven enterprise dedicated to world-class science can succeed by inventing medicine and vaccine innovations that make a difference for patients across the globe.

Who we are …

We are known as Merck & Co., Inc., Kenilworth, New Jersey, USA in the United States and Canada and MSD everywhere else. For more than a century, we have been inventing for life, bringing forward medicines and vaccines for many of the world’s most challenging diseases. Today, our company continues to be at the forefront of research to deliver innovative health solutions and advance the prevention and treatment of diseases that threaten people and animals around the world.

What we look for …

Imagine getting up in the morning for a job as important as helping to save and improve lives around the world. Here, you have that opportunity. You can put your empathy, creativity, digital mastery, or scientific genius to work in collaboration with a diverse group of colleagues who pursue and bring hope to countless people who are battling some of the most challenging diseases of our time. Our team is constantly evolving, so if you are among the intellectually curious, join us—and start making your impact today.

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Skills

Posted on

April 28, 2022