Requirements
- At least six years of experience in the pharmaceutical industry or a related field, with a focus on regulatory labeling updates and associated processes.
- Hands-on experience managing labeling workflows, documentation systems, and international labeling variations including translation, readability assessments, and harmonization efforts.
- Demonstrated verbal and written communication proficiency.
- Proven ability to collaborate effectively within teams while also leading initiatives and contributing at a strategic level.
- Excellent organizational abilities, with flexibility to manage multiple responsibilities under pressure while maintaining high accuracy and attention to detail.
- Mandatory expertise in MS Office applications and project management software.
- Knowledge of GMP standards and experience operating within a highly regulated environment, including solid understanding of GxP and GMP compliance frameworks.
Nice to Have
- Experience drafting procedural documents such as Standard Operating Procedures (SOPs) and user instructions, along with managing change control processes.
- Familiarity with Regulatory Information Management (RIM) systems.
