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Director, Regulatory Affairs/Labeling


Upper Gwynedd, PA
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Job Details

Job Title: Director, Regulatory Affairs/Labeling  - LAB000679


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 is on a quest for cures and is committed to being the world’s premier, most research-intensive biopharmaceutical company. Today, we’re doubling down on this goal. Merck Research Laboratories is a true scientific research facility of tomorrow, and will take Merck’s leading discovery capabilities and world-class small molecule and biologics R&D expertise to create breakthrough science that radically changes the way we approach serious diseases. 

  • As Director, Regulatory Affairs/Labeling, lead a labeling team with responsibility for preparation of labeling for new products for inclusion with Worldwide Marketing Applications, and revised labeling for marketed products; presentation of proposed labeling to the Merck Labeling Committees for review and approval; and preparation of labeling for submission to Health Authorities and/or subsidiaries worldwide.  Develop labeling strategy and ensure strategic alignment and consistency across the labeling for assigned portfolio of products.  Determine timelines for labeling deliverables for regulatory filings, approvals and compliance activities, and ensure that such timelines are met.
  • Interact with country-level Regulatory Affairs staff on key strategic labeling and regulatory issues.  These interactions include management of the review of local country labeling by the Labeling Committees.
  • Manage compliance and quality activities for assigned team



Education Requirement:

  • B.S. in a scientifically or medically-related discipline. 
  • Master's Degree preferred.

Required Experience:

  • Minimum of 10 years pharmaceutical experience.  Minimum of 5 years labeling experience.  Prior management experience required.  Proven ability in medical writing.  Process improvement, and compliance/quality experience.  Experience leading teams, driving consensus and results.  Excellent leadership, communication and collaboration skills.

Preferred Experience:

  • Industry experience in the cardiovascular/metabolism and primary care therapeutic areas.

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


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.


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




Job Labeling Specifications

Primary Location NA-US-PA-Upper Gwynedd

Other Locations NA-US-NJ-Rahway

Employee Status Regular

Number Of Openings 1

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