Regulatory Affairs Manager

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

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