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Senior Manager, Regulatory Labeling, USA (remote)

Contract: W2 or 1099

Closing Date: 28/06/24

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This is an exciting contract role for a regulatory professional with expertise in labeling. 

We are seeking someone proactive and dynamic, with excellent communication skills and a can-do attitude.

The role can be fully remote, or hybrid working on-site with this global biopharma company.

The Role

The key responsibilities of this role are as follows:

  • Driving labeling strategy in partnership with the Global Regulatory Team Leader in line with the overall regulatory Strategy by providing labeling expertise (labeling regulations, internal processes, and competitor analyses) for CCDS, USPI, and SmPC (Centralized / Mutual Recognition / Decentralized Procedure) for medium to low complex projects in the Lifecycle Management (LCM) projects.
  • Serving as primary contact for cross-functional Labeling Team, and working as an interface for Country Regulatory Managers to support timely and quality submissions globally.
  • Coordinating labeling activities of multifunctional contributors, reviewers, and approvers and managing the label review and approval process to maximize speed and quality.
  • Ensuring the effective planning of all cross-functional labeling activities.
  • Reviewing country labels to ensure labeling compliance.
  • Supporting responses to labeling-related inquiries from Global Health Authorities and those related to inspection activities.
  • Participating in key initiatives (Process Improvements, Development of new tools, technologies) to support efficient global label development and worldwide submissions and approvals.

Requirements

  • A Masters of Life Sciences or equivalent, with a thorough understanding of scientific principles or a Bachelor of Life Sciences with at least 2 years of Labeling/Regulatory Experience.
  • Good Understanding of Drug Development and Commercialization of prescription medicines.
  • Ability to understand regulatory implications of product strategy related to labeling development, assessment, and management.
  • Excellent verbal and written communication skills.
How to Apply

For further details, please send your CV to: talent@gandlhealth.com

G&L Healthcare Advisors is an equal opportunities employer and welcomes applicants from all sections of the community regardless of their gender, religious belief, political opinion, sexual orientation, disability, age, marital status or race.

We recruit based on talent alone and firmly believe that an individual’s background should play no part in the recruitment and selection process.

G&L is committed to everyone having the right to work in an environment free from threat of discrimination, intimidation, harassment, and abuse. All employees at G&L share the responsibility to challenge discriminatory behaviour and promote equality of opportunity.

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