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Merck Animal Health Seeks Sr. Specialist Regulatory Affairs (Animal Health)

May 30, 2019

Position Title                                                                                                                                         Merck
Senior Specialist Regulatory Affairs 
                                                                             

 

Job Description

Merck’s Animal Health (MAH) 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.                                          

Merck 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 Merck 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.

 

Qualifications

 

Education Minimum Requirement:  

Bachelor’s degree in a relevant discipline such as molecular biology, animal science, veterinary technology, immunology, regulatory or law with a minimum of 5 years of regulatory or vaccine experience or Master’s degree in a relevant discipline with 3 years of regulatory or vaccine experience. 

 

Required Experience and Skills**: 

  • Knowledge of USDA requirements and regulations relating to manufacturing of biological vaccines.
  • Knowledge of molecular biology
  • Computer skills and working knowledge of Microsoft Office 
  • Excellent written and verbal communication skills 
  • Ability to demonstrate clear motivation and focus on achieving measurable and tangible results.

 

Preferred Experience and Skills:

  • Prior animal health regulatory experience
  • Supervisory experience
  • Practical veterinary or animal science experience
  • Knowledge of animal health product development
  • Knowledge and understanding of the animal health sector

 

 

(US/Puerto Rico Only) 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. If you have any questions, please contact your HRBP or Staffing Consultant.

 

 

 

 

 

 
 
 
 

Your role at Merck is integral to helping the world meet new breakthroughs that affect generations to come, and we’re counting on your skills and inventiveness to help make meaningful contributions to global medical advancement.  At Merck, we’re inventing for life. 

 

If you need assistance and/or a reasonable accommodation due to a disability during the application or the recruiting process, please send a request to  staffingaadar@merck.com.

 

 

  


Search Firm Representatives Please Read Carefully: 

Merck & Co., Inc. is not accepting unsolicited assistance from search firms for this employment opportunity.  Please, no phone calls or emails.  All resumes submitted by search firms to any employee at Merck via email, the Internet or in any form and/or method without a valid written search agreement in place for this position will be deemed the sole property of Merck.  No fee will be paid in the event the candidate is hired by Merck as a result of the referral or through other means.

 

Visa sponsorship is not available for this position.

  

For more information about personal rights under Equal Employment Opportunity, visit:

       EEOC Poster

            EEOC GINA Supplement 

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