Regulatory Affairs Manager

Global Labeling Strategy Lead (Contract) Global Pharmaceutical Company EST timezone (remote) - US based Full-time | 6‑month contract Competitive hourly rate Start: ASAP 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 Interpret evolving FDA / EMA guidance impacting labelling strategy 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 Interested? Apply via LinkedIn or contact us directly for a confidential discussion .