Director, Global Labeling Compliance

Job Description

CSL Behring is a global biotechnology leader, guided by a promise to save and improve lives. Millions of people around the world are living with rare and serious medical conditions. CSL Behring is committed to delivering medicines that improve their lives.

With operations in 35+ nations and ~ 30,000 employees worldwide, CSL is inspired to develop and deliver a broad range of lifesaving therapies to treat disorders such as hemophilia and primary immune deficiencies, and vaccines to prevent influenza. Our therapies are also used in cardiac surgery, organ transplantation and burn treatment. CSL is the parent company of CSL Behring, CSL Plasma, CSL Seqirus and CSL Vifor. CSL Behring is a global leader in the protein biotherapeutics industry, focused on bringing to market biotherapies used to treat serious and often rare conditions.

Could you be our next Director, Global Labeling Compliance? This position could be located in King of Prussia PA, Marburg Germany, Bern Switzerland, Broadmeadow Australia, Maidenhead, UK or Melbourne Australia office. It is a Hybrid role. You will report to the Head of Global Labeling

You will provide leadership and technical expertise for the maintenance and monitoring of prescription drug or device product labeling to meet global labeling regulatory compliance requirements. You will be a Global Labeling Compliance representative on relevant teams., lead projects and process-improvement initiatives and establish project compliance strategies and executes project tasks.

Main Responsibilities and Accountabilities:

• Lead the establishment of end-to-end labeling processes throughout the company utilizing partner participation to ensure compliance.
• Guide global labeling compliance processes and process improvements within cross-divisional teams.
• Evaluate existing processes related to labeling management and labeling compliance tracking and reporting globally. Analyze systems status and interrelation. Identify areas for process improvements.
• Manage relationships to ensure control and continuous improvement of global labeling programs to meet our needs and regulatory requirements.
• Establish Process and System Best Practices: Serves as a role model and leads the use and implementation of labeling best practices. Help develop Standard Operating Procedures (SOPs) and process improvements.
• Prepare training and information sessions with GRA and other departments to increase understanding and compliance with internal and external labeling expectations and labeling strategies.
• Represent Global Labeling during internal and external audits and inspections.
• Represent Global Labeling during quality investigations globally.

Qualifications:

• University degree (4 year degree) in Life Sciences or related Pharmaceutical field (e.g. Chemistry, Engineering)
• 10+ years regulatory experience in the pharmaceutical industry, Biologics Regulatory
• At least 5 years leadership experience.
• Knowledge of principles of regulatory requirements relevant to drug development, global labeling and post-marketing requirements.
• Proficient regulatory knowledge including an understanding of broad concepts within labeling and implications across the organization and globally.

BENEFITS

• Medical, Dental Vision
• 401K
• Paid time Off

#LI-Hybrid

CSL employees that work at least 30 hours per week are eligible for benefits effective day 1. We are committed to the wellbeing of our employees and their loved ones. CSL offers resources and benefits, from health care to financial protection, so you can focus on doing work that matters. Our benefits are designed to support the needs of our employees at every stage of their life. Whether you are considering starting a family, need help paying for emergency back up care or summer camp, looking for mental health resources, planning for your financial future, or supporting your favorite charity with a matching contribution, CSL has many benefits to help achieve your goals.

Please take the time to review our to see what’s available to you as a CSL employee.

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 .

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