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 and Accountabilities:

1 Supports cross-functional, end-to-end non-US/Central EU global labeling processes across the company utilizing cross-functional stakeholder partnership.

2 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.

3 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.

4 Ensures consistent communication to the regions and countries regarding updates to CCDSs that will impact labeling revisions and related implementation.

5 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.

6 Remains up to date with the global labeling requirements and expectations.

7 Represents Global Labeling in internal and external meetings as needed.

8 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.

9 Leadership: leads by example, role modeling Driving Performance, Building Productive Teams, and Creating the Future – consistent with CSL’s Leadership Values and instills these values in team members.

Minimum of 5 years of biotech/pharmaceutical industry experience. This is inclusive of 2+ years of labeling/regulatory experience combined with other global responsibility.

Experience leading teams in a matrix organization is expected. Managing team members is an advantage.
Different qualifications or responsibilities may apply based on local legal and/or educational requirements. Refer to local job documentation where applicable.

Competencies

• 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 cross-cultural 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)

Our Benefits

We encourage you to make your well-being a priority. It’s important and so are you. Learn more about how we care at CSL.

About CSL Behring

CSL Behring is a global leader in developing and delivering high-quality medicines that treat people with rare and serious diseases. Our treatments offer promise for people in more than 100 countries living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. Learn more about CSL Behring.

We want CSL to reflect the world around us

As a global organization with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion at CSL.

Do work that matters at CSL Behring!