Manager, Labeling Operations

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 egulatory 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 TAs Global Labeling Experts GRA Regulatory CMC and End-to End Supply groups.

Main Responsibilities & Accountabilities

• Supports cross-functional end-to-end non-US/Central EU global labeling processes across the company utilizing cross-functional stakeholder partnership.
• Assesses labeling changes for MOW for differences in meaning and emphasis and participates in the respective labeling exception approval process with the
• Global Labeling Committee (GLC) nor non-US/Central EU labelling.
• Helps resolve issues between the countries and Product Care Quality and Supply
• Chain related to artwork creation translation and implementation through use of established processes systems and best practices.

• Ensures consistent communication to the regions and countries regarding updates to CCDSs that will impact labeling revisions and related implementation.
• Leads the assessment and as necessary Global Labeling Committee (GLC) review of proposed exceptions between the CCDS and the MOW labeling when meaning and/or emphasis are changed utilizing established departmental processes. Escalates differences and issues to the Director Global Labeling
• Operations as necessary. Remains up to date with the global labeling requirements and expectations.
• Represents Global Labeling in internal and external meetings as needed.
• Builds effective cross-functional networks with GRA (regional and global) as well as across functions within Product Care Quality and the End-to-End Supply Chain.

Qualifications & Experience

Requirements

• University degree in Life Sciences or related
• Pharmaceutical field (e.g. Chemistry Engineering); advanced degree
• (MSc PhD or Pharm D) helpful.
• Biotech/pharmaceutical industry experience. This is inclusive of experince in labeling/regulatory experience combined with other global responsibility.
• Knowledge and understanding of principles of regulatory requirementsrelevant 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)
  

About CSL Seqirus

CSL Seqirus is part ofCSL. As one of the largest influenza vaccine providers in the world CSL Seqirusis a major contributor to the prevention of influenza globally and a transcontinental partner in pandemic preparedness. With state-of-the-art production facilities in the U.S. the U.K. and Australia CSL Seqirus utilizes egg cell and adjuvant technologies to offer a broad portfolio of differentiated influenza vaccines in more than 20 countries around the world.

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