Global Labeling Lead

Sobi•Boston, MA

3d•$155,000 - $190,000•Remote

About The Position

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.

Requirements

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.
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.
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.

Nice To Haves

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.

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.

Benefits

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
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.