Regulatory Affairs - Labeling

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:

• At least 2 years’ experience in the pharmaceutical industry in operational roles, project management or regulatory affairs.
• Excellent communication and organizational skills, with a proven ability to simultaneously balance diverse activities for several projects.
• Good interpersonal skills.
• Excellent attention to detail and quality-oriented

What we offer:

• Exciting work in a great team, global projects, international environment
• Opportunity to learn and grow professionally within the company globally
• Hybrid working model, flexible role pattern
• Pension and health insurance contributions
• Internal reward system plus referral program
• 5 weeks annual leave, 5 sick days, 15 days of certified sick leave paid above statutory requirements annually, 40 paid hours annually for volunteering activities, 12 weeks of parental contribution
• Cafeteria for tax free benefits according to your choice (meal vouchers, sport, culture, health, travel, etc.), Multisport Card
• Vodafone, Raiffeisen Bank, Foodora, and other discount programs
• Up-to-date laptop and iPhone
• Parking in the garage for drivers or showers for bikers
• Competitive salary, incentive pay, and many more

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 Labeling

Preferred 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:

Regular

Relocation:

No relocation

VISA Sponsorship:

No

Travel Requirements:

No Travel Required

Flexible Work Arrangements:

Hybrid

Shift:

Not Indicated

Valid Driving License:

No

Hazardous Material(s):

NA

Job 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.