Job Description

Specialist, International Labeling Support (AP)

Job Description:

The Specialist, International Labeling Support (ILS) will partner cross functionally within GRACS and cross divisionally where applicable to ensure Labeling and Artworks regulatory operational activities within scope of ILS are planned, managed, and executed timely, accurately and in a compliant way.

The role is responsible for supporting local labeling implementation activities, maintaining regulatory records and databases, and driving operational excellence through continuous process improvement initiatives. 

 

Key Responsibilities:

• Prepares high-quality labeling and artwork package aligned in accordance with company requirements and provides operational support to Country Regulatory Affairs (CRA) for regulatory activities (database maintenance, regulatory record management) within the ILS scope of work.
• Ensure labeling and artwork deliverables are completed accurately and within established timelines.
• Supports the preparation of the metrics for the designated business process.
• Collaborates with Global Labeling, CRA, and other stakeholders to resolve labeling and artwork-related queries.
• Supports necessary updates to process documentation, work instructions, and training materials.
• Participate in cross-functional initiatives that identify opportunities to improve, simplify, and streamline processes and tools.

Education:

Bachelor's degree (Pharmaceutical Sciences, Biotechnology, Life Sciences, Pharmacy, or a related discipline is preferred)

Requirements:

• Minimum 2 years of experience in the pharmaceutical, biotechnology, healthcare, or related industry.
• Prior experience in Regulatory Affairs, labeling and artwork management, CMC, quality, compliance, or regulatory operations is preferred. Experience with regulatory systems, databases, or document management systems is an advantage.
• Strong organizational skills with the ability to manage multiple priorities and meet deadlines.
• Good interpersonal and communication skills, with the ability to collaborate effectively across functions and regions.
• Detail-oriented with a strong focus on quality, accuracy, and compliance.
• Proficient in Microsoft 365 applications
• Open to exploring emerging technologies, including AI-enabled solutions, and applying them creatively and responsibly to enhance business processes and ways of working.

Required Skills:

Biological Sciences, Biotechnology, Business Processes, Continuous Process Improvement, Detail-Oriented, Emerging Technologies, Life Science, Operational Excellence, Pharmaceutical Regulatory Affairs, Pharmaceutical Sciences, Process Documentation, Regulatory Affairs Compliance

Preferred Skills:

Business Development, Communication, Computer Applications, Creativity, Electronic Records Management (ERM), Empathy, Industry Knowledge, Inventory Management, Life Cycle Logistics, Manufacturing, Medical Affairs, Organizational Behavior, Packaging, Policy Development, Process Planning, Product Manufacturing, Project Planning, Quality Assurance Compliance, Regulatory Compliance, Safety Practices, Security Practices, Technical Leadership, Training Instruction, Waterfall Model

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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:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Hybrid

Shift:

Valid Driving License:

Hazardous Material(s):

Job Posting End Date:

09/30/2026

*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.