The person in charge of overseeing and managing all regulatory matters - Tremont, United States - Velocity Enterprises

Velocity Enterprises
Velocity Enterprises
Verified Company
Tremont, United States

4 weeks ago

Meredith Sinclair

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Meredith Sinclair

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Description

Head of Regulatory Affairs

Your Responsibilities

  • Development and implementation of the regulatory affairs strategy for new and existing products in Germany
  • Leadership of the regulatory affairs team
  • Negotiations and interactions with health authorities for pharmaceuticals, medical devices, and cosmetics
  • Responsibility as Regulatory Information Officer according to § 74a, §8 AMG
  • Management of regulatory activities for the entire product portfolio in different categories
  • Ensuring compliance with product licenses and timely updates
  • Establishing and maintaining effective relationships with health authorities and standardization committees

Your Qualifications

  • Completed degree in pharmacy or bachelor's degree in pharmaceutical sciences
  • Several years of experience in regulatory affairs for pharmaceuticals, medical devices, and/or cosmetics
  • Experience as a Regulatory Information Officer according to §74a, §8 AMG
  • Excellent knowledge of German legislation and regulation for pharmaceuticals
  • Strong leadership skills and experience in team management
  • Negotiation skills and interaction with high-level stakeholders
  • Comprehensive knowledge of GxP regulations and SOPs.

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