Regulatory Affairs - Labeling
Merck & Co.
This listing was originally posted on Merck & Co.'s careers page. Formulate is an equal opportunity job aggregator and is not involved in the hiring process. Where salary information is estimated, it is derived from BLS industry benchmarks and may differ from actual compensation.
Job Description
We invite you to join our mission of advancing the prevention and treatment of diseases. The purpose of Global Labeling is to drive labeling strategy and ensure high-quality and compliant labeling documents which provide instructions for the safe and effective use of products for patients and healthcare providers globally.
As part of the Labeling Operational Excellence function in Global Labeling, the Labeling Operations Specialist is responsible for:
Serving as the primary labeling operations point of contact for Global, US, and EU Labeling Leads
Receiving, reviewing, and processing labeling operational tasks for Core, US and EU labeling update requests on schedule, ensuring timely resolution of any issues throughout the update cycle while ensuring all labeling deliverables meet regulatory standards and timelines with consistent, high-quality execution
Performing labeling operational tasks (quality checks, verifications, proofreading, creation of labeling documents, including US SPL, and updating trackers)
Providing effective functional oversight in situations where a vendor performs labeling operational tasks
Collaborating with cross-functional teams to prioritize and manage labeling operational support for labeling updates, which may include product launches
Being Subject Matter Experts (SMEs) for labeling operational tasks and relevant business processes, systems, and documentation, including supporting process documentation updates
Monitoring and compiling competitor labeling for strategy development and decision‑making to Global, US and EU Labeling Leads
Required Experience & Skills:
What we offer:
Required Skills:
Detail-Oriented, Labeling Systems, Medical Writing, Policy Implementation, Preventive Action, Prioritization, Promotional Review, Proofreading, Regulatory Affairs Management, Regulatory Communications, Regulatory Compliance Audits, Regulatory LabelingPreferred Skills:
Current Employees apply HERE
Current Contingent Workers apply HERE
Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
Employee Status:
RegularRelocation:
No relocationVISA Sponsorship:
NoTravel Requirements:
No Travel RequiredFlexible Work Arrangements:
HybridShift:
Not IndicatedValid Driving License:
NoHazardous Material(s):
NAJob Posting End Date:
05/15/2026*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.
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