Senior Specialist, Regulatory Liaison (Animal Health)
- New Century, KS
Our company is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where our company has codified its legacy for over a century. Our company's success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare. Our company's Animal Health (AH) Division works to improve the health of animals around the world through collaborative partnerships and a deep sense of responsibility towards our customers, consumers, animals, society, and planet.
This team of energetic, independent thinkers offers one of the industry's most innovative portfolios of products, services, and technologies that serve to prevent, treat, and control diseases across all major farm and companion animal species both domestically and internationally. Our company's Animal Health, DeSoto, KS is a BioTechnology Center of Excellence that manufactures, fills, packages and distributes vaccines for animals.
As a member of the Regulatory Affairs Biologics team, the Senior Specialist is responsible but is not limited to the following duties:
- Regulatory species sub-team leader responsible for pre-and post licensure activities
- Manages direct reports in support of regulatory submissions, performance management goals and priorities.
- Represents our company's Animal Health in communications and submissions to the USDA as an Alternate Liaison.
- Subject matter expert for regulatory procedures and serve as regulatory stakeholder for internal change controls.
- Review, prepare and approve regulatory documents for USDA government submission.
- Provide scientific guidance to the regulatory team on new and upcoming technologies proposed for manufacture of vaccines.
- Assists with obtaining documents and creation of standard international dossiers for International registration of vaccines.
- 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.
- Strong working 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.
- Previous experience with animal health vaccines preferred but not required
- People management skills preferred but not required
Our Animal Health division is a trusted global leader in veterinary medicine, dedicated to the health and well-being of animals. We are a global team of professionals working together to make a positive difference in animal care and the world's food supply and have a deep sense of responsibility towards our customers, consumers, animals, society and our planet. We offer one of our industry's most innovative portfolio of products, services and technologies that serve to prevent, treat, and control diseases across all major farm and companion animal species.
Who we are ...
Merck & Co., Inc., Kenilworth, New Jersey, USA is known as "Merck" in the United States, Canada & Puerto Rico. We are known as "MSD" in Europe, Middle East, Africa, Latin America & Asia Pacific. We are a global biopharmaceutical leader with a diverse portfolio of prescription medicines, oncology, vaccines and animal health products.
We are driven by our purpose to develop and deliver innovative products that save and improve lives. With 69,000 employees operating in more than 140 countries, we offer state of the art laboratories, plants and offices that are designed to Inspire our employees as we learn, develop and grow in our careers. We are proud of our 125 years of service to humanity and continue to be one of the world's biggest investors in Research & Development.
What we look for ...
In a world of rapid innovation, we seek brave Inventors who want to make an Impact in all aspects of our business, enabling breakthroughs that will affect generations to come. We encourage you to bring your disruptive thinking, collaborative spirit and diverse perspective to our organization. Together we will continue Inventing For Life, Impacting Lives while Inspiring Your Career Growth.
NOTICE FOR INTERNAL APPLICANTS
In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.
If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.
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