Position Description Summary The Manager, Global Labeling Associate (GLA) focuses on end-to-end non-US/Central EU (Most of World) labeling development and implementation. This position provides innovation and technical expertise for the creation, maintenance and implementation of labeling to meet country-specific regulatory requirements and effectively manages labeling operations globally. Additionally, this role participates in a ‘follow the sun’ model for the review and escalation of differences in local labeling as they relate to the company core position. Key partner to GRA Regions, GRA GPS TA’s, Global Labeling Experts, GRA Regulatory CMC and End-to-End Supply groups. Main Responsibilities advanced degree (MSc, PhD or Pharm D) helpful. Biotech/pharmaceutical industry experience. This is inclusive of experience in labeling/regulatory experience combined with other global responsibility. Knowledge and understanding of principles of regulatory requirements relevant to drug development, global labeling and post-marketing requirements. Demonstrated problem-solving ability able to analyze risk and make appropriate recommendations/decisions. Must work well with others and within global teams, particularly crosscultural exposure. Experience working in a complex and matrix environment is required. Organizational skills to interact seamlessly both internally and externally on regulatory compliance matters. Proficient regulatory knowledge including an understanding of scientific concepts within labeling and implications across the organization and globally. Effective communication skills, specifically related to the explanation of concepts, options and impact. Attention to detail, coupled with the ability to think strategically. Fluency in English (verbal and written). Equal Opportunity Employer CSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process, please visit accessibility-statement. CSL Global Privacy Notice for Job Applicants and Candidates.
Manager, Labelling Operations, Seqirus employer: CSL
CSL Seqirus is an excellent employer that fosters a collaborative and inclusive work culture, making it an ideal place for a Global Financial Analyst. With a strong focus on employee growth and development, the company offers numerous opportunities for professional advancement while providing a hybrid working model that promotes work-life balance. Located in Speke, Liverpool, employees benefit from a vibrant community and the chance to engage with diverse teams across the globe, enhancing both personal and professional experiences.
