Associate Director, Regulatory Affairs/Labeling

  • Company: Merck
  • Location: Pennsylvania, United States
  • Posted: November 16, 2016
  • Reference ID: LAB000578
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. Today, we are building a new kind of healthcare company - one that is ready to help create a healthier future for all of us.

Our ability to excel depends on the integrity, knowledge, imagination, skill, diversity and teamwork of an individual like you. To this end, we strive to create an environment of mutual respect, encouragement and teamwork. As part of our global team, you'll have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career.


As Associate Director/Artwork Leader, Regulatory Affairs/Labeling:
Co-own the global end-to-end labeling Standard Operating Procedures (SOPs) regarding artwork including compliance and quality processes.
Ensure labeling compliance with all applicable FDA and customs regulations across all labeling components in the Merck portfolio of products including serialization.
Assess new regulatory guidances and regulations as well as implementation of such guidances and regulations into the global labeling processes.
Oversee the artwork processes and interactions with supply chain and manufacturing sites.

Accountable for labeling artwork deliverables and management of labeling staff with responsibility for preparation of labeling artwork for new products for inclusion with Worldwide Marketing Applications, and revised labeling artwork for marketed products; presentation of proposed labeling artwork to the Merck Labeling Committees for review and approval; and preparation of labeling artwork for submission to FDA.

Oversee timelines for labeling deliverables for regulatory filings, approvals and compliance activities for assigned team, and ensure that such timelines are met.
Lead labeling process improvement initiatives.
Support compliance and quality initiatives including CAPA development, tracking and completion.

Support global labeling process for device development.
Support IT systems to ensure labeling compliance and quality.

Education Minimum Requirement:
  • B.S. in a scientifically or medically-related discipline or other relevant degree. Master's Degree preferred.
Required Experience and Skills:
  • Minimum of 10 years pharmaceutical/biological labeling artwork experience or relevant professional experience.
  • Regulatory submission experience.
  • Expertise in labeling regulations and arkwork processes.
  • Detail oriented, well organized, and excellent planning skills.
  • Experience leading teams, driving consensus and results.
  • Excellent leadership, communication, interpersonal and collaboration skills.
  • Adobe Acrobat, Microsoft Office, Docu-Proof experience

Our employees are the key to our company's success. We demonstrate our commitment to our employees by offering a competitive and valuable rewards program. Our Company's benefits are designed to support the wide range of goals, needs and lifestyles of our employees, and many of the people that matter the most in their lives. If you need an accommodation for the application process please email us at
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