Global Regulatory Labeling Manager - Freelance (m,f,d)

Overview

Global Regulatory Labeling Manager - FREELANCE (m/w/d)

Shape global clinical trial labeling across 50+ countries

An international biotechnology company based in Germany is seeking an experienced freelance Global Regulatory Labeling Manager to provide high-impact regulatory expertise in the area of clinical trial labeling.

This is a unique opportunity to work at the intersection of global Regulatory Affairs, multilingual labeling strategy, and clinical trial operations, with direct influence on labeling approaches across more than 50 countries.

If you are a seasoned Regulatory Affairs professional, enjoy working globally, and have a passion for smart, compliant labeling solutions, then this is certainly a very attractive opportunity for you.

Your Role

Global Regulatory Labeling Strategy

• Analyse and interpret global regulatory requirements for clinical trial labeling
• Determine where reduced English master labels are acceptable - and where local language or full content is required
• Assess regulatory minimum requirements per country and health authority
• Build a clear, country-by-country overview of permitted and non-permitted label reductions

Phrase Library Oversight

• Review and optimise existing label phrases and text fragments
• Support and validate translations of regulatory-relevant content
• Ensure all wording is accurate, compliant, clear, and complete
• Where required, coordinate with certified translators/interpreters for official translations

Clinical Trial Supplies (CTS) Support

• Act as a regulatory sparring partner to CTS and Regulatory Affairs teams
• Provide expert guidance on questions such as:
  Are specific reductions acceptable? Are phrases compliant? What applies in country X?
• Bridge regulatory expectations with practical labeling execution

Documentation & Ongoing Compliance

• Create and maintain a structured global labeling requirements document, including sources
• Perform regular reviews (e.g. annual) to ensure continued compliance
• Track regulatory changes and clearly document updates

Stakeholder & Authority Communication

• Clearly explain regulatory decisions and rationale to internal stakeholders
• Support the preparation of response strategies for authority questions related to labeling

Your Profile

• Broad global Regulatory Affairs expertise, ideally across multiple regions
• Strong experience with IMP / clinical trial labeling
• Proven ability to interpret complex authority requirements and translate them into practical guidance
• Experience working with English master labels

Languages - Major Advantage

• German, English, French, and Spanish are a significant plus, as they already cover a large proportion of relevant countries
• Additional languages are very welcome

Nice to Have

• Certified / sworn translator or interpreter (particularly useful for official or notarised translations)

Start, Volume, Duration, Model

• Start: ASAP
• Volume: Approx. 10-15 hours per week (ad hoc or monthly allocation)
• Duration: 6 months, with strong potential for extension
• Model: Freelance

If this opportunity is alligned to your current career endeavour, I\'d be happy to hear from you with a current CV.

If you\'re not currently available, feel free to share this role within your network - it could be a great fit for someone you know.

Kind regards from sunny Munich,

Charlotte

Charlotte Valentiner de Scheffold
Principal Candidate Consultant - Pharma & Biotech at SThree GmbH

Desired Skills and Experience

Regulatory Affairs, Labeling

SThree_Germany is acting as an Employment Business in relation to this vacancy.