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 advanced degree? (MSc, Ph D 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 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) About CSL Seqirus CSL Seqirus is part of CSL.

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.

To learn more about CSL, CSL Behring, CSL Seqirus and CSL Vifor visit https://www. csl. com/ and CSL Plasma at https://www. cslplasma. com/.

Our Benefits For more information on CSL benefits visit How CSL Supports Your Well-being | CSL.

You Belong at CSL At CSL, Inclusion and Belonging is at the core of our mission and who we are.

It fuels our innovation day in and day out.

By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future.

To learn more about inclusion and belonging visit https://www. csl. com/careers/inclusion-and-belonging 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 https://www. csl. com/accessibility-statement.

Watch our On the Front Line video to learn more about CSL Seqirus JBRP1_UKTJ