Associate Director Regulatory Affairs (Animal Health)

Employer
Merck
Location
Madison, NJ, US
Posted
April 12 2018
Organization Type
Pharma
Requisition ID: REG003693

Merck & Co., Inc. Kenilworth, N.J., U.S.A. known as Merck in the United States and Canada, 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 Merck has codified its legacy for over a century. Merck’s success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare. 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.   The Associate Director of US Pharmaceutical Regulatory Affairs has the following major responsibilities:   
  • To represent US Regulatory Affairs on cross-functional pharmaceutical development teams for new pharmaceutical products.  This involves providing regulatory guidance and experience to the team, facilitating meetings and discussions with FDA/CVM, and working with team members to prepare and submit all types of high quality submissions to FDA/CVM in a timely manner in order gain the most efficient approvals and launch new products on schedule. 
  • To establish and maintain good relationships with FDA/CVM based on trust, integrity, and respect
  • To build strong knowledge of FDA guidance and policy and to effectively communicate this information within the company as needed.
  • To maintain the registered US products throughout their lifecycle which includes supporting label changes and extensions as well as reviewing advertising and promotional labeling
  • To actively participate on various internal project teams related to optimization of processes, procedures, and infrastructure, as needed.
Qualifications

Education Minimum Requirement:  
  • M.S. Degree in a relevant scientific discipline and 8 years of pharmaceutical experience
  • Doctorate-level Degree (i.e. DVM or Ph.D.) in a relevant scientific discipline and 4 years of pharmaceutical experience 
Required Experience and Skills:
  • Minimum 5 years of regulatory and/or product development experience
  • Strong written and oral communication skills
  • Excellent people, communication and leadership skills
  • Must be organized, able to manage time effectively, and pay attention to detail 
Preferred Experience and Skills:
  • Prior animal health regulatory experience
  • Practical veterinary or animal science experience
  • Knowledge of animal health product development
  • Knowledge and understanding of the animal health sector
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

Job: Regulatory Affairs Generic
Other Locations:
Employee Status: Regular
Travel: Yes, 5 % of the Time
Number of Openings:
Shift (if applicable):
Hazardous Materials:
Company Trade Name: Merck

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