Global Labelling Leader - Senior Regulatory Affairs

Valtera Group Ltd; Washington, Baltimore (District of Columbia, MD); Hybrid; USD 180,000 - 240,000; Full time

Benefits offered by this job

Flexible working arrangement

Job summary

Global Pharmaceutical Company is seeking an experienced, senior labelling leader to own global product labelling across a defined portfolio. This hands-on leadership role acts as the global steward for core and major-market labelling, guiding lifecycle decisions and balancing regulatory risk with commercial objectives.

Responsibilities include CCDS ownership, major-market label translation (US PI, EU SmPC), governance, and strategic input to regulatory submissions, with cross-functional

Qualifications

• 7–10+ years of Regulatory Affairs experience with global labelling responsibility.
• Proven ownership of CCDS and major-market labels (US/EU).
• Experience supporting regulatory submissions in key markets.
• Strong background in Target Product Labelling (TPL) development and lifecycle labelling.

Responsibilities

• Own and maintain CCDS and patient information globally.
• Lead translation of global data into major-market labels (US/EU).
• Manage global vs local deviations and support Health Authority interactions.
• Lead complex labelling updates across the product lifecycle.

Skills

Global labelling

Regulatory affairs

CCDS management

Major-market labels

TPL development

Lifecycle strategy

Cross-functional leadership

Regulatory submissions

Education

Bachelor's degree in Science/Medicine/Pharmacy

Advanced degree advantageous

Job description

Global Pharmaceutical Company is seeking an experienced, senior labelling leader to own global product labelling across a defined portfolio. This hands-on leadership role acts as the global steward for core and major-market labelling, guiding lifecycle decisions and balancing regulatory risk with commercial objectives.

Responsibilities include CCDS ownership, major-market label translation (US PI, EU SmPC), governance, and strategic input to regulatory submissions, with cross-functional