Global Labeling Lead

Responsibilities:

• Lead 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.

Qualifications:

• 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.

Skills:

• Regulatory Information Management systems experience.
• Strong proficiency with standard business tools (e.g. MS-Office, etc.)
• Excellent English language skills (oral/written/listening); additional languages are an advantage.

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.