Job Description:

The Sr. Specialist, International Labeling Support (ILS) plays a pivotal role in ensuring the timely, accurate, and compliant execution of labeling and artwork regulatory operations. This position partners cross-functionally within GRACS and across divisions to support the end-to-end labeling process, including development, maintenance, and artwork implementation. The role also contributes to continuous process improvement, compliance oversight, and training initiatives, while serving as a subject matter expert in labeling-related investigations and audits.

Specific responsibilities include:

• Prepares high quality labeling, artwork package aligned with company requirements and provides operational support to Country Regulatory Affairs on regulatory activities (database maintenance, records filings) according to the ILS scope of work.

• Prepares and reports metrics related or the designated business process.

• Collaborates with Global Labeling, Country/Regional Regulatory Affairs, for labeling & artworks queries.

• Facilitates updates to process documentation and contribute to re-engineering/simplification efforts.

• Delivers training and support knowledge-sharing initiatives on labeling procedures.

• Leads or contribute to continuous improvement, re-engineering, and simplification of labeling and artwork processes and related tools.

• Ensures the necessary follow-ups and escalations cross functionally and cross divisionally, as applicable after certain milestones being reached (e.g. HA submissions and approvals).

• Provides SME support for Level 2 labeling-related issues and significant investigations.

• Assists in audit and inspection readiness related to ILS scope of work.

• Partners with Country Regulatory Affairs to collect necessary inputs and country requirements for the accurate planning and execution of the business process.

• Participates in cross functional/divisional projects for coordination, planning and implementation of changes with impact on Labeling/artworks: CMC changes with artwork impact, artwork preparation for launches, liaising with country regulatory affairs where necessary.

Education:

• Bachelor’s degree in life science, engineering, business or a related field (ideally pharmaceutical science degree)

• Master’s degree (desired)

Requirements:

• Minimum 3-5 years experience in pharmaceutical industry.

• Previous experience in Regulatory Affairs (including artwork & labeling), CMC, compliance management or Quality, working with external partners and/or dealing directly with regulatory agencies is preferred.

• Desirable to be familiar with local and regional legislation frameworks, procedures and guidelines governing pharmaceutical products.

• Preferably some knowledge of Company’s business and organizational set-up

• Understanding of Operational Excellence principles,

• Ability to work through a matrix approach in a culturally diverse environment across the regions

• Good organizational skills with a proven ability to simultaneously balance diverse activities for several projects.

• Good interpersonal/communication skills

• Detail and quality oriented.

• Able to master Microsoft 365 apps (Excel, Power point, Share Point.).

• Technology proficient; Interest in new tools or automatization will be needed.

• Innovative mindset and design thinking skills.

Required Skills:

Adaptability, Adaptability, Applied Engineering, Audits Compliance, Business Processes, Communication, Continuous Process Improvement, Database Administration, Design Thinking, Detail-Oriented, Documentations, Drug Regulatory Affairs, Employee Training Programs, Global Communications, Leadership, Life Science, Multi-Management, Operational Excellence, Pharmaceutical Process Engineering, Pharmaceutical Regulatory Affairs, Pharmaceutical Sciences, Pharmacovigilance, Planning, Process Improvements, Project Management {+ 4 more}

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):

no

Job Posting End Date:

04/21/2026

**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.