Specialist, International Labeling Support

Job Description

Specialist International Labeling Support

The Opportunity

• Exciting opportunity to join an innovative and trusted Global biopharmaceutical company

• Permanent Full-time opportunity

• Work autonomously whilst being supported encouraged and being part of a trusted Global leading Pharmaceutical organization

The Specialist International Labeling Support (ILS) will partner cross functionally within Global Regulatory Affairs & Clinical Safety(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.

What you will do:

• 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.

What You Must have

• Bachelors degree(Pharmaceutical Sciences Biotechnology Life Sciences Pharmacy or a related discipline is preferred)

• 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:

Preferred Skills:

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