Job Description

This position leads the Global Labeling strategy team at Sobi and provide strategic directions on global labeling issues. In addition, the Artwork management team at IQVIA has a dotted line to this role. The Head of Global Labeling has the role as Global Process Owner with responsibility for the labeling process and governance.

Key Responsibilities/Scope of the Job

Including, but not limited to the following:

• Provide oversight of product labeling at Sobi
• Promotes partnerships with project/program teams to ensure key submission milestones are met
• Sets functional goals which contribute to the departments vision and long-range planning
• Leads a team of Global Labeling leads and Labeling Co-ordinator
• Provides line management to direct reports including training, performance management, professional development and coaching
• Provides excellent understanding of labeling requirements and guidance
• Manages Sobi Executive Labeling Committee (ELC) and is responsible for follow-up on ELC decisions regarding labeling
• Ensures that product labeling reflects a complete and accurate description of the risks and benefits of Sobi products based on available data
• Ensures timely creation and updates of CDS that represent Sobi’s position on maximum efficacy and core safety of Sobi’s products and approval of CDS deviations
• Provides oversight of labeling operations work including artwork and mock-up creation and updates
• Makes decisions on administrative and operational matters and ensures the labeling team effectively achieves its objectives
• Utilize strategic thinking and risk assessment capabilities in your area of responsibility
• Maintain knowledge of global competitive landscape, regulatory environment, regulations, and best practices
• Contribute to the development and maintenance of Regulatory Affairs working practices & procedures
• Additional duties may be assigned, as needed

Qualifications

Education/Learning Experience/Work Experience

• A University Degree in Life Sciences is required with 10 years of industry experience of which at least 8 years of experience within Regulatory Affairs in a Labeling role and at least 5 years of formal people management
• Diverse experience working with a variety of pharmaceutical products
• Extensive experience working with regulatory labeling for Prescription medicines and interacting with Regulatory Agencies including the US FDA on labeling issues
• Experience leading and managing updates to prescribing information
• Extensive experience working in a global environment
• Experience of leading projects and cross-functional teams

Skills/Knowledge/Languages

• Extensive knowledge of Labeling regulations and guidance
• Thorough knowledge of the drug development process, with a focus on IND and NDA processes
• Above-average proficiency with basic technology tools (e.g. MS-Office, etc.)
• Demonstrate excellent communication skills (oral/written/listening) in English. Knowledge of any other languages would be an asset

_ Personal Attributes_

• Results driven and team-oriented attitude with the ability to influence outcomes
• Excellent organizational and time management skills to effectively manage multiple ongoing projects simultaneously
• Proven ability to innovate, especially with analysing & solving problems, with minimal supervision and exceptionally keen skills for attention to detail
• Proven success in simultaneously handling strategic and transactional responsibilities, especially in a small-team environment

Additional Information

All Sobi employees need to demonstrate behaviors in line with Sobi's core values: Care, Ambition, Urgency, Ownership and Partnership. Are you ready to be on the Sobi team? Come join a culture that empowers every person to be the person that makes a difference for rare disease.

Why Join Us?

We are a global company with over 1,700 employees in more than 30 countries and are committed to the societies where we operate. With a deeply skilled management team directing our day-to-day wins, and a Board with a stellar track record, we’re ready to take on the world’s diseases, ailments and adversity. Our people believe they have the power to make a positive impact in others’ lives because that’s exactly what we do here. If you’re seeking a career that taps into your talents in a way that makes the world a better, healthier place, we just may have a job for you.

We know our employees are our most valuable asset, and our culture conveys that. We offer a competitive benefits package, to support the health and happiness of our staff.

Sobi Culture

At Sobi, we refuse to accept the status quo. This is because we have witnessed first-hand the challenges facing those affected by rare diseases, and have used this knowledge to shape our business to find new ways of helping them.

As a specialized biopharmaceutical company, we are dedicated to rare diseases. And we see this focus as a strength. By effectively turning our research into ground-breaking treatments, we help make medicine more accessible and open up more possibilities for patients and more opportunities for those caring for them. This has been our approach since day one, but we know we can’t change the world of rare diseases on our own. Accomplishing this requires strong partnerships with patients, partners and stakeholders across the entire value chain. Together, we define how our business can create solutions that serve the needs of those affected by rare diseases while facilitating sustainable growth.

An Equal Opportunity Employer

Sobi is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. All employment decisions at Sobi are based on business needs, job requirements and individual qualifications, without regard to race, color, religion or belief, national, social or ethnic origin, sex (including pregnancy), age, physical, mental or sensory disability, HIV Status, sexual orientation, gender identity, protected veterans and/or expression, marital, civil union or domestic partnership status, past or present military service, family medical history or genetic information, family or parental status, or any other status or protected groups by the laws or regulations in the locations where we operate.

Sobi is an affirmative action and equal opportunity employer. Disabled/Veterans. If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation if you are unable or limited in your ability to use or access this website to apply for a vacancy as a result of your disability. You can request reasonable accommodations by sending an email to talentacquisition@sobi.com.