Global Labeling Lead

Company Description

Statistics show that women and underrepresented groups tend to apply to jobs only if they meet 100% of the qualifications. Sobi encourages you to change that statistic and apply. Rarely do candidates meet 100% of the qualifications. We look forward to your application!

At Sobi, each person brings their unique talents to work as a team and make a difference. We are dedicated to developing and delivering innovative therapies to improve the lives of people who live with a rare disease. Our edge comes from our team of people and our commitment to patients.

Our mission and culture at Sobi North America get us excited to come to work every day, but here are a few more reasons to join our team:

• Competitive compensation for your work
• Generous time off policy
• Opportunity to broaden your horizons by attending popular conferences
• Emphasis on work/life balance
• Collaborative and team-oriented environment
• Making a positive impact to help ultra-rare disease patients who are in need of life saving treatments

Job Description

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.…