Director, Global Labelling Strategy

Meet Life Sciences Ltd.

Deutschland

Remote

EUR 150,000 - 210,000

Full time

14 days+

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Job summary

Meet Life Sciences Ltd. is seeking a Director / Associate Director, Global Labelling Strategy to drive labelling initiatives across development and marketed products.

This highly visible Regulatory Affairs role partners with international stakeholders to shape global product labelling. You'll lead the development of TPL, CCDS, SmPCs and related documents, advise cross-functional teams, and support major regulatory submissions.

Qualifications

  • Significant experience in regulatory affairs or global labelling within pharma or consulting.
  • Expertise in global labelling strategy including TPL, CCDS, SmPC and product information development.
  • Understanding of European labelling regulations with exposure to UK requirements; USPI experience is desirable.
  • Experience supporting products from early development through regulatory submissions and lifecycle activities.
  • Strong stakeholder management skills in a global matrix environment.

Responsibilities

  • Lead global labelling strategy activities across development and commercial products with a focus on EU/UK markets.
  • Drive the development and maintenance of Target Product Labelling (TPL), CCDS, SmPCs and related core labelling documents.
  • Provide strategic regulatory labelling guidance to cross-functional partners throughout the product lifecycle.
  • Lead responses to labelling-related health authority interactions and support major regulatory submissions.
  • Collaborate with Regulatory, Clinical, Safety, Medical Affairs and US-based stakeholders to ensure global alignment.

Skills

Regulatory Affairs
Global Labelling
TPL/CCDS/SmPC
European labelling
Lifecycle management
Stakeholder management

Job description

Job Title: Director, Global Labelling Strategy

Location: UK or Germany | Remote

Employment Type: Full Time, Permanent

We're partnering with a leading global pharmaceutical organisation to appoint an experienced Director / Associate Director, Global Labelling Strategy.

This is a highly visible global role within Regulatory Affairs, focused on driving labelling strategy across development and marketed products. You'll work closely with international stakeholders, leading labelling initiatives from early development through lifecycle management, while helping shape global product labelling across key markets.

What you'll be doing:
  • Lead global labelling strategy activities across development and commercial products, with a focus on EU and UK markets
  • Drive the development and maintenance of Target Product Labelling (TPL), CCDS, SmPCs and related core labelling documents
  • Provide strategic regulatory labelling guidance to cross-functional partners throughout the product lifecycle
  • Lead responses to labelling-related health authority interactions and support major regulatory submissions
  • Collaborate closely with Regulatory, Clinical, Safety, Medical Affairs and US-based stakeholders to ensure global alignment
What we're looking for:
  • Significant experience within Regulatory Affairs or Global Labelling in the pharmaceutical or consulting environment
  • Strong expertise in global labelling strategy, including TPL, CCDS, SmPC and product information development
  • Solid understanding of European labelling regulations, with exposure to UK requirements; USPI experience is highly desirable
  • Experience supporting products from early development through post-approval lifecycle activities
  • Strong stakeholder management skills with the ability to influence cross-functional teams in a global matrix environment
Nice to have:
  • Experience working across both European and US labelling environments
  • Exposure to innovative therapies, specialty products or complex development programmes
  • Consultancy background with experience supporting multiple product portfolios
Why consider this opportunity?
  • Strategic global labelling role with significant influence across development and commercial programmes
  • Fully remote position offering flexibility and international collaboration
  • Join an established, highly respected global labelling function led by experienced industry experts
  • Collaborative, supportive and low-ego culture with strong cross-functional partnerships
  • Excellent opportunity to shape global labelling strategy and contribute to high-profile regulatory initiatives
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