Job Description
Specialist, International Labeling Support (AP)
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
Other Details
•Employee Status: Regular
•Flexible Work Arrangements: Hybrid
•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)
