Regulatory Affairs Manager

Valtera Group Ltd · Washington, United States

Global Pharmaceutical Company

The Opportunity

A global pharmaceutical organisation is seeking an experienced, senior labelling leader to take end‑to‑end ownership of global product labelling across a defined portfolio.

This is a hands‑on leadership role with genuine accountability - not a support or execution‑only position. You will act as the global steward for core and major‑market labelling , shaping how data is translated into claims, guiding lifecycle decisions, and balancing regulatory risk with commercial objectives.

Key Responsibilities

Global Labelling Ownership

• Own and maintain global Core Data Sheets (CCDS) and associated patient information
• Lead translation of global data into major‑market labels (e.g. US PI, EU SmPC)
• Manage global vs local deviations and support Health Authority interactions
• Lead complex labelling updates across the product lifecycle

Strategy & Lifecycle Input

• Develop and maintain Target Product Labelling (TPL) to support development and regulatory positioning
• Conduct competitive labelling analyses and regulatory precedent assessments
• Provide labelling input to global regulatory strategy and major submissions

Governance & Cross‑Functional Leadership

• Chair or lead cross‑functional Product Labelling Teams
• Escalate key issues through formal governance pathways as required
• Partner closely with Regulatory, Medical, Safety, Clinical, and Commercial teams
• Review and approve promotional and non‑promotional materials for compliance with core labelling and applicable codes

Scientific & Regulatory Judgement

• Critically evaluate clinical and non‑clinical data for labelling adequacy
• Balance regulatory compliance, business needs, and risk

Candidate Profile

Experience

• 7–10+ years’ experience in Regulatory Affairs with significant global labelling responsibility
• Proven ownership of CCDS and major‑market labels (US and EU)
• Experience supporting regulatory submissions in key markets
• Strong background in TPL development and lifecycle labelling strategy

Capabilities

• Senior‑level judgement and decision‑making
• Comfortable leading in complex, matrixed global environments
• Able to influence cross‑functional stakeholders at all levels
• Clear, confident scientific and regulatory communicator

Education

• Bachelor’s degree in Science, Medicine, Pharmacy, or related field
• Advanced degree advantageous but not required

Why This Role

• True global ownership , not regional execution
• Strategic influence over claims, positioning, and submissions
• High‑impact contract role with senior‑level accountability
• Flexible working arrangement