Global Labeling Strategist - Contract
Global Labeling Strategist - Contract

Global Labeling Strategist - Contract

Newcastle upon Tyne Freelance 36000 - 60000 £ / year (est.) No home office possible
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At a Glance

  • Tasks: Shape global labeling strategies and manage regulatory documentation for diverse products.
  • Company: Join a leading life sciences company making a global impact in healthcare.
  • Benefits: Enjoy a fully remote role with flexible working options and corporate perks.
  • Why this job: Make a strategic impact while collaborating with cross-functional teams in a dynamic environment.
  • Qualifications: Experience in regulatory labeling and strong project management skills required.
  • Other info: Ideal for professionals eager to influence global health standards.

The predicted salary is between 36000 - 60000 £ per year.

A leading life sciences company is seeking a Global Labeling Strategist to join its international Regulatory Affairs team. This position offers the opportunity to shape and manage global labeling strategies across a diverse portfolio, working with regulatory documentation such as the Company Core Data Sheet (CCDS), US Package Inserts (USPI), and EU Summary of Product Characteristics (SmPC). This is a fully remote role, ideal for professionals looking to make a strategic impact in regulatory labeling across global markets.

Key Responsibilities:

  • Develop and drive global labeling strategies in alignment with regulatory and product objectives.
  • Manage updates and compliance of CCDS, USPI, and SmPC for products registered via Centralized, Mutual Recognition, or Decentralized Procedures.
  • Serve as the primary point of contact for the Labeling Strategy Team (LST).
  • Collaborate closely with cross-functional teams including Regulatory, Clinical, Medical, and Safety functions to ensure timely and compliant label updates.
  • Coordinate and oversee end-to-end labeling activities and submission planning.
  • Support responses to health authority inquiries and inspection-related labeling issues.
  • Review country-specific labels to ensure accuracy and global consistency.

Candidate Requirements:

  • Experience in regulatory labeling for at least one major market (e.g., US, EU).
  • Solid understanding of global regulatory procedures, GxP requirements, and lifecycle management.
  • Hands-on experience managing CCDS, SmPC, and USPI development and updates.
  • Strong project management skills with experience in coordinating cross-functional teams.
  • Excellent verbal and written communication abilities.
  • Attention to detail and a thorough understanding of clinical and scientific documentation.

Desirable Skills:

  • Experience with global health authority submissions and queries.
  • Ability to influence and guide internal stakeholders and subject matter experts.
  • Familiarity with centralized and decentralized product registration processes.
  • Prior experience working in a matrixed or global team environment.

Global Labeling Strategist - Contract employer: AL Solutions

As a leading life sciences company, we pride ourselves on fostering a dynamic and inclusive work culture that empowers our employees to thrive. This fully remote role as a Global Labeling Strategist not only offers competitive benefits and flexible working arrangements but also provides ample opportunities for professional growth and development within our international Regulatory Affairs team. Join us to make a meaningful impact in global regulatory labeling while collaborating with diverse cross-functional teams dedicated to innovation and excellence.
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Contact Detail:

AL Solutions Recruiting Team

StudySmarter Expert Advice 🤫

We think this is how you could land Global Labeling Strategist - Contract

✨Tip Number 1

Familiarise yourself with the specific regulatory frameworks of the major markets, especially the US and EU. Understanding the nuances of CCDS, USPI, and SmPC will give you an edge in discussions and demonstrate your expertise during interviews.

✨Tip Number 2

Network with professionals in the regulatory affairs field, particularly those who have experience in global labeling strategies. Engaging with industry groups or attending relevant webinars can help you gain insights and potentially connect with someone at StudySmarter.

✨Tip Number 3

Prepare to discuss specific examples of how you've managed labeling updates and compliance in previous roles. Highlighting your project management skills and ability to coordinate cross-functional teams will showcase your fit for this position.

✨Tip Number 4

Stay updated on the latest trends and changes in global regulatory procedures. Being knowledgeable about current events in the life sciences sector will not only prepare you for interviews but also show your commitment to the field.

We think you need these skills to ace Global Labeling Strategist - Contract

Regulatory Labeling Expertise
Knowledge of CCDS, USPI, and SmPC
Understanding of Global Regulatory Procedures
GxP Compliance Knowledge
Lifecycle Management Skills
Project Management Skills
Cross-Functional Team Coordination
Excellent Verbal and Written Communication
Attention to Detail
Clinical and Scientific Documentation Proficiency
Experience with Health Authority Submissions
Stakeholder Influence and Guidance
Familiarity with Centralized and Decentralized Registration Processes
Experience in a Matrixed or Global Team Environment

Some tips for your application 🫡

Understand the Role: Before applying, make sure you fully understand the responsibilities and requirements of the Global Labeling Strategist position. Familiarise yourself with terms like CCDS, USPI, and SmPC, as well as the regulatory landscape.

Tailor Your CV: Highlight your relevant experience in regulatory labeling, especially in major markets like the US or EU. Emphasise your project management skills and any hands-on experience with CCDS, SmPC, and USPI development.

Craft a Compelling Cover Letter: Use your cover letter to showcase your understanding of global regulatory procedures and your ability to collaborate with cross-functional teams. Mention specific examples of how you've successfully managed labeling strategies in the past.

Proofread Your Application: Ensure that your CV and cover letter are free from errors and clearly articulate your qualifications. Attention to detail is crucial in this role, so make sure your application reflects that quality.

How to prepare for a job interview at AL Solutions

✨Showcase Your Regulatory Knowledge

Make sure to highlight your experience with regulatory labeling, especially in major markets like the US and EU. Be prepared to discuss specific examples of how you've managed CCDS, USPI, and SmPC updates.

✨Demonstrate Project Management Skills

Since this role requires strong project management abilities, come ready to share instances where you've successfully coordinated cross-functional teams. Discuss how you ensured timely compliance and updates in your previous roles.

✨Prepare for Technical Questions

Expect questions about global regulatory procedures and GxP requirements. Brush up on these topics and be ready to explain how they relate to lifecycle management and labeling strategies.

✨Emphasise Communication Skills

Given the collaborative nature of this position, be prepared to demonstrate your verbal and written communication skills. Share examples of how you've effectively communicated with various stakeholders to achieve successful outcomes.

Global Labeling Strategist - Contract
AL Solutions
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  • Global Labeling Strategist - Contract

    Newcastle upon Tyne
    Freelance
    36000 - 60000 £ / year (est.)

    Application deadline: 2027-05-21

  • A

    AL Solutions

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