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Senior Associate Regulatory Affairs - Merck Animal Health

Merck


Location:
Madison, NJ
Date:
08/30/2017
2017-08-302017-09-29
Job Code:
REG003151
Merck
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Job Details

Job Title: Senior Associate Regulatory Affairs - Merck Animal Health  - REG003151

Description

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.


Merck’s Regulatory Affairs organization helps bring new medical advancements to the world by facilitating the communications and procedures that allow swift, organized compliance across regulatory agencies. As a team of energetic, results-driven individuals, we’re a global network on the leading-edge of healthcare breakthroughs that help provide new, reliable, and compliant medical products, practices, and solutions to the world on time, every time. 

 
As a Senior Specialist in the Global Regulatory Affairs CMC Pharmaceuticals team, the Senior Specialist is responsible, but is not limited to the following duties: 

  • Prioritize and manage FDA CMC submissions adhering to timelines and liaising regularly with FDA, where appropriate. 
  • Work effectively with other functions to manage and prepare regulatory CMC dossiers, renewals, annual reports, variations, supplements, and responses to authority questions as required in each country in order to gain new and maintain existing product registrations 
  • Assess post approval changes, provide regulatory filing strategies and timelines, identify risks and propose mitigation strategies 
  • Actively participate on new product development teams as well as other types of teams and initiatives and deliver on all assigned regulatory milestones 
  • Maintain regulatory information in accordance with processes and procedures to support regulatory compliance 
  • Continuously build and share knowledge of CMC related regulations and guidelines (including but not limited to FDA-CVM, EMA, and VICH), authority expectations, as well as current industry standards 
  • Identify and communicate potential regulatory issues to management, as needed.


Qualifications

Education Minimum Requirement:

  • Bachelor of Science degree (minimum) in science, engineering, or other relevant field (advanced degree preferred).

Required Experience and Skills:

  • At least 2 years of experience in pharmaceutical research, manufacturing, or quality
  • Proficient in English
  • High level of professionalism
  • Experience reviewing scientific information
  • Demonstrated oral and written communication skills
  • Understanding of related fields (manufacturing, testing, and quality assurance)
  • Leadership skills (problem solver, ability to deal with multiple priorities, strong interpersonal skills, sound judgment and attentive to details)
  • Previous exposure/knowledge of CMC regulations and guidelines.

Preferred Experience and Skills:

  • Previous experience in a CMC regulatory affairs position is preferred.
  • Strong working knowledge of CMC regulations and guidelines associated animal health products.
  • Excellent time and project management skills.
  • Proficiency in additional languages such as Spanish, French, or German is a plus.

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 an accommodation for the application process please email us at 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:

 

            

            



Job Regulatory Affairs - CMC

Primary Location NA-US-NJ-Madison

Other Locations 

Employee Status Regular

Number Of Openings 2

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