Global Labeling Lead

The Global Labeling Lead (GLL) serves as a labeling strategy expert for Sobi products within Global Regulatory Affairs (GRA). 

The GLL provides both strategic and operational leadership for product labeling working closely with Regulatory Strategy Leads and other cross-functional stakeholders. As a core member of the Global Regulatory Team(s) (GRT) for assigned product(s) the GLL ensures that product labeling reflects scientific integrity regulatory compliance and patient focus across global markets.

This is a remote position based in the US - candidates located on the East Coast are strongly preferred. 

Key Responsibilities:

• Lead the content development approval and maintenance of the Company Core Data Sheet (CCDS) and US/EU Product Information (PI).
• Manage the review and approval of country labeling for new filings in international markets.
• Ensure compliance with relevant Health Authority (HA) regulations internal procedures and business objectives.
• Support continuous improvement of labeling processes and systems.
• Lead the development implementation and maintenance of the CCDS USPI and EU PI for Sobi products throughout the product lifecycle via cross-functional Labeling Working Groups (LWG).
• Guide LWGs in labeling discussions with HAs while ensuring management alignment and adherence to labeling governance. Collaborate closely with internal stakeholders and partner companies as applicable. Document and archive LWG decisions and outcomes.
• Present new labeling content and major updates to the Executive Labeling Committee for approval.
• Partner with international Regulatory Affairs (RA) to guide the review and approval process of labels for submission outside of EU and US.
• Maintain oversight of labeling compliance including documentation of labeling content deviations and end-to-end tracking of safety variations.
• Contribute to the development and improvement of labeling processes including creation and review of process documents.
• Support inspections and audits related to labeling activities.
• Participate in cross-functional and cross-regional initiatives to strengthen collaboration and increase operational efficiencies.

Qualifications :

Education/Learning Experience/Work Experience

Required: 

• Degree (Bachelors Masters State Examination Diploma) preferably in a scientific discipline such as Pharmacy Medicine Life or Natural Sciences.
• At least 5 years of experience in Regulatory Affairs within the pharmaceutical industry or a regulatory authority including at least 3 years of relevant experience in US prescription drug labeling.
• Comfortable working in a global cross-functional environment collaborating effectively with stakeholders across multiple regions time zones and cultural backgrounds.

Desired: 

• Experience working with different types of labeling documents including (Development) Core Data Sheets Prescribing Information and Target Product Labels for both marketed and investigational products.
• Knowledge of labeling requirements and templates in geographic regions outside of the US preferably Europe and/or Japan.
• Experience leading project teams in a cross-functional matrix environment.

Skills/Knowledge/Languages

• Experience with Regulatory Information Management systems.
• Strong proficiency with standard business tools (e.g. MS-Office etc.)
• Excellent English language skills (oral/written/listening); additional languages are an advantage.
• Ability to plan coordinate and lead multiple projects concurrently.

Personal Attributes

• Self-motivated able to work independently in a remote setting while staying connected and collaborative with global colleagues.
• Flexible and resilient comfortable navigating shifting priorities and maintaining focus in a fast-paced environment.
• Reliable and accountable taking ownership of tasks and consistently delivering high-quality precise work.
• Team-oriented and empathetic able to build strong relationships and foster trust in a virtual multicultural environment. Contributing to a supportive team culture and helping others succeed.
• Process-aware and compliant understanding the importance of regulatory frameworks while exercising sound judgment and balanced decision-making within scope.
• Strong communicator able to confidently present and discuss cases at all levels of the organization including leadership teams and steering committees.
• Curious and proactive learner seeking out information staying current and continuously developing expertise.

Additional Information :

Compensation and Total Rewards at Sobi

At Sobi we are dedicated to providing our employees with a comprehensive and industry-competitive total rewards package. Our compensation philosophy is designed to recognize and reward talent ensuring that your contributions are valued and reflected in your overall rewards.

Your total compensation at Sobi goes beyond just your base salary and annual bonus. It also includes a robust suite of benefits such as:

• A competitive 401(k) match to support your financial future.
• Tuition and wellness reimbursements to invest in your personal and professional growth.
• A comprehensive medical dental and vision package to prioritize your health and well-being.
• Additional recognition awards to celebrate your achievements.

The base salary range for this role is $155000-$190000. Each individual offer will be determined based on several factors including your experience qualifications and location. Additionally this role is eligible for both short-term and long-term bonuses as outlined in the plan details.

All Sobi employees need to demonstrate behaviors in line with Sobis 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 1900 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 were ready to take on the worlds diseases ailments and adversity. Our people believe they have the power to make a positive impact in others lives because thats exactly what we do here. If youre 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 cant 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.

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   

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Remote Work :

Yes

Employment Type :

Full-time