Regulatory Affairs Specialist, International Labeling Support (ILS) (Open)

Job Description

The Specialist, International Labeling Support will partner cross functionally within GRACS and cross divisionally where applicable to ensure all the Labeling and Artworks regulatory operational activities in scope of ILS are planned, managed, and executed timely, accurately and in a compliant way. The role includes any identification of opportunities for process improvement and participation in their implementation.  

 

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. 

• Supports the preparation of the metrics for the designated business process.  

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

• Supports necessary process documentation updates and periodic revisions.  

• Contributes to improvement or re-engineering/simplification of the process and related tools. 

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

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

• Supports when required 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.  

Qualifications, Skills & Experience

Education:

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

Requirements:

• Minimum 2 - 3 years’ experience in pharmaceutical industry.
• Previous experience in Regulatory Affairs (including labelling & artwork), 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 business and organizational set-up
• Understanding of Operational Excellence principles
• Ability to work through a matrix approach in a culturally global environment across the regions
• Good organizational skills with a proven ability to simultaneously balance global activities for several projects.
• Good interpersonal/communication skills
• Detail and quality oriented.
• Able to master Microsoft 365 apps (Excel, Power point, SharePoint).
• Technology proficient; Interest in new tools or automatization will be needed.
• Innovative mindset and design thinking skills.

Required Skills:

Detail-Oriented, Documentation Preparation, Employee Training Programs, Management Review, Regulatory Affairs Compliance, Regulatory Affairs Management, Regulatory Experience, Regulatory Governance, Regulatory Management, Regulatory Reporting, Regulatory Strategy Development, Regulatory Submissions

Preferred Skills:

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Current Contingent Workers apply HERE

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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:

10/1/2026

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