Regulatory Affairs Associate Specialist, International Labeling Support (ILS)

Job Description

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.
• Interest in continuous improvement and openness to applying simple operational excellence principles in daily work.
• Ability to collaborate respectfully in a matrix and multicultural environment with support from more experienced colleagues.
• Good organizational skills with the ability to manage assigned tasks, follow timelines, and seek guidance when priorities need clarification.
• Clear written and verbal communication skills, with willingness to ask questions and escalate when needed.
• Attention to detail and commitment to quality, with ability to follow instructions and check work carefully.
• Basic proficiency with Microsoft 365 apps, including Outlook, Excel, PowerPoint, Teams, and SharePoint, with willingness to build stronger technical skills.
• Comfortable learning new digital tools and supporting simple automation or process efficiency opportunities under guidance.
• Curious mindset and openness to contributing ideas for simple improvements.

Additional location(s) Compensation Information:

Required Skills:

Electronic Common Technical Document (eCTD), Regulatory Affairs Management, Regulatory Compliance, Regulatory Compliance Audits, Regulatory Management, Regulatory Processes, Regulatory Reporting, Regulatory Strategy Development, Regulatory Submissions, Support Coordination

Preferred Skills:

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Employee Status:

Regular

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Hybrid

Shift:

Valid Driving License:

Hazardous Material(s):

Job Posting End Date:

11/30/2026

*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.