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Merz Therapeutics
last mo.

Regulatory Affairs Manager - Labeling & Regulatory Intelligence(m/w/x)

Frankfurt am Main
Full-timeWith Home OfficeExperienced

Description

In this role, you will play a crucial part in shaping regulatory strategies and ensuring compliance for medicinal products. Daily tasks will involve reviewing data sheets, coordinating translations, and optimizing labeling processes while collaborating with local regulatory teams.

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Requirements

  • •Completed scientific studies in natural sciences or pharmacy
  • •Pharmacist license
  • •2+ years of professional experience in pharmaceutical industry
  • •Experience in regulatory affairs
  • •Experience with labeling
  • •Strong knowledge of international regulatory frameworks and standards
  • •Strong project management and analytical thinking ability
  • •Team player with excellent communication and problem-solving abilities
  • •Business fluent in German and English

Education

Master's degree

Work Experience

2 years

Tasks

  • •Review Company Core Data Sheets (CCDS)
  • •Implement CCDS into national product information texts for EEA, CH, and UK
  • •Coordinate translations and ensure compliance and timely provision
  • •Initiate, review, and approve artwork changes for EEA, CH, and UK
  • •Collaborate closely with local regulatory affairs
  • •Support submissions and responses to authority queries
  • •Optimize labeling and artwork processes
  • •Train colleagues on the artwork management system
  • •Act as a key user for Merz’ artwork management system
  • •Lead and monitor the Regulatory Intelligence process in Global Regulatory Affairs
  • •Further develop the Regulatory Intelligence process

Languages

German – Business Fluent

English – Business Fluent

Benefits

Competitive Pay

  • •Attractive remuneration

Other Benefits

  • •Extensive social benefits
  • •Attractive location

Career Advancement

  • •Individual career development

Flexible Working

  • •Hybrid work model

Family Support

  • •Good work-life balance

Parking & Commuter Benefits

  • •Good transport links

Modern Office

  • •Modern workplaces

Free or Subsidized Food

  • •Company restaurant

Informal Culture

  • •Flat hierarchies
  • •Open corporate culture

Additional Allowances

  • •Employer-subsidized benefits

Healthcare & Fitness

  • •WellPass

Public Transport Subsidies

  • •Deutschland-ticket

Corporate Discounts

  • •Corporate Benefits

Company Bike

  • •JobBike
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