Director, Global Regulatory Affairs CMC (Animal Health)

Employer
Merck
Location
Madison, NJ, US
Posted
April 23 2018
Organization Type
Pharma
Requisition ID: REG003692

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. 


Hire staff; ensure training; establish ongoing responsibilities and annual objectives; monitor performance and provide ongoing feedback; conduct routine individual and group staff meetings; and perform year-end activities consistent with Merck processes

  • Collaborate cross-functionally  with manufacturing, quality, technical support, R&D, and marketing; direct the CMC team efforts to ensure all important global CMC submission milestones are met; support the CMC team members to work effectively with other functions to develop robust regulatory strategies and high quality regulatory submissions
  • Critically review key CMC submissions
  • Support the development and maintenance of standard processes and systems to maintain regulatory information to support regulatory compliance.  This may involve leading complex projects related to these processes or systems.
  • Maintain and foster current in depth knowledge and experience applying the EMA, FDA, VICH, and other country specific CMC/Quality related guidelines to pre- and post-approval CMC submissions. 
  • Facilitate and participate in meetings and/or inspections with the regulatory authorities on behalf of the company; in particular, act as the primary liaison with FDA-CVM on regulatory CMC related topics.
  • Identify and communicate potential regulatory issues to management, as needed.

Qualifications

Education Minimum Requirement:


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


Required Experience and Skills:

  • BS with minimum 10 years pharmaceutical experience including at least 5 years in CMC regulatory environment or DVM/PhD with minimum 5 years experience in CMC regulatory environment
  • Excellent time and project management skills
  • Strong leadership and communication skills (both written and oral)
  • Self-motivated, flexible & creative leader, able to prioritize, multi-task and work in a fast-paced and demanding environment. 
  • Supervisory experience strongly preferred.
  • Experience critically reviewing detailed scientific information to ensure information is presented clearly and conclusions are supported by data. 
  • Strong understanding of related fields (manufacturing, analytical, quality assurance, and R&D).
  • Strong written and verbal communication skills in multicultural settings and ability to communicate in a succinct,  logical manner.   
  • Good listener.   
  • Able to deal with changing priorities or unexpected events.
Preferred Experience and Skills:

  • Experience working in a global company is preferred

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, 20 % of the Time
Number of Openings: 1
Shift (if applicable): 1st
Hazardous Materials: NO
Company Trade Name: Merck

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