The Associate Specialist, International Labeling Support will support cross-functional collaboration within GRACS and, where applicable, cross-divisionally to help ensure that Labeling and Artwork regulatory operational activities in scope of ILS are planned, coordinated, and executed in a timely, accurate, and compliant way. The role contributes to routine operational activities, supports issue resolution under guidance, and may identify practical opportunities for process improvement.
Specific responsibilities include:
Supports the preparation of high-quality labeling and artwork packages and all related activities aligned with company requirements and provides routine operational support to Country Regulatory Affairs on regulatory activities, such as database maintenance and record filing, according to the ILS scope of work.
Engages with Global Labeling, Country/Regional Regulatory Affairs, on labeling and artwork queries, with guidance from more experienced team members as needed.
Assists with process documentation updates and periodic revisions under guidance.
Contributes to process improvement or simplification initiatives by providing operational input and supporting implementation activities.
Supports follow-ups and prepares escalation information for review by senior team members, as applicable after key milestones are reached, such as HA submissions and approvals.
Works with Country Regulatory Affairs to collect required inputs and country requirements to support accurate planning and execution of labeling and artwork business processes.
Provides operational support to cross-functional or cross-divisional projects, when required, by assisting with coordination, planning, and implementation activities related to changes with labeling or artwork impact, such as CMC changes, artwork preparation for launches, and liaison with Country Regulatory Affairs where necessary.
Qualifications, Skills & Experience
Education:
Bachelor’s degree or equivalent experience in life sciences, pharmacy, regulatory affairs, business, or a related field.
Requirements:
Entry-level profile; previous internship, apprenticeship, or up to 1 year of experience in the pharmaceutical industry, regulatory affairs, quality, supply chain, or another regulated environment is desirable.
Basic awareness of Regulatory Affairs, labeling, artwork, quality, compliance, or pharmaceutical operations is preferred; willingness to learn is essential.
Awareness of the importance of working within procedures, guidelines, and regulatory requirements; detailed knowledge can be developed on the job.
Basic understanding of company structure and ways of working, or ability to quickly learn internal processes and systems.
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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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