Global Labeling Strategist in Regulatory Affairs — Remote

TECCON Consulting GmbH

Österreich

Hybrid

EUR 68,000 - 83,000

Full time

10 days ago

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Benefits offered by this job

Flexible working hours
Remote work options
Career development opportunities

Job summary

TECCON Consulting GmbH in Hamburg is seeking an experienced Regulatory Affairs professional to lead global labeling initiatives for development and marketed products. You will collaborate with regulatory, pharmacovigilance, medical affairs and commercial teams to drive labeling strategies.

The ideal candidate has 2–3 years in Global Labeling or Regulatory Affairs, a Master’s or PhD in a related field, and fluent English.

Qualifications

  • 2–3 years of regulatory labeling or regulatory affairs experience in pharma.
  • Strong understanding of labeling requirements across global markets.
  • Experience in leading cross-functional projects in a matrix environment.

Responsibilities

  • Develop and implement labeling strategies for development and marketed products.
  • Define submission strategies and assess labeling requirements across global markets.
  • Evaluate safety-related labeling changes and provide regulatory input on CDS and risk communication.
  • Prepare and review labeling documents and responses to Health Authority queries.
  • Support regulatory interactions with Health Authorities.
  • Lead cross-functional workstreams and ensure timely delivery of labeling packages.
  • Contribute to process optimization of labeling processes and regulatory systems.

Skills

Regulatory affairs
Labeling
Project management
Communication
Problem solving
English proficiency

Education

Master’s/PhD in related field

Job description

TECCON Consulting GmbH in Hamburg is seeking an experienced Regulatory Affairs professional to lead global labeling initiatives for development and marketed products. You will collaborate with regulatory, pharmacovigilance, medical affairs and commercial teams to drive labeling strategies.

The ideal candidate has 2–3 years in Global Labeling or Regulatory Affairs, a Master’s or PhD in a related field, and fluent English.

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