At a Glance
- Tasks: Shape global labeling strategies and manage regulatory documentation for life sciences products.
- Company: Join a leading life sciences company focused on innovative regulatory affairs across Europe and the US.
- Benefits: Enjoy a fully remote role with flexible working options and opportunities for professional growth.
- Why this job: Make a strategic impact in global markets while collaborating with diverse teams in a dynamic environment.
- Qualifications: Experience in regulatory labeling, strong project management skills, and excellent communication abilities required.
- Other info: This is a contract position ideal for those looking to advance their career in regulatory affairs.
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.
- 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.
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 and guidelines relevant to global labeling, particularly for the US and EU markets. This knowledge will not only help you in interviews but also demonstrate your commitment to understanding the role.
✨Tip Number 2
Network with professionals in the Regulatory Affairs field, especially those who have experience in global labeling strategies. Engaging with industry experts can provide valuable insights and potentially lead to referrals.
✨Tip Number 3
Prepare to discuss your project management skills in detail, as this role requires coordinating cross-functional teams. Think of specific examples where you've successfully managed projects and how you ensured compliance and timely updates.
✨Tip Number 4
Stay updated on recent changes in global health authority regulations and labelling requirements. Being knowledgeable about current trends will show your proactive approach and readiness to tackle challenges in the role.
We think you need these skills to ace Global Labeling Strategist - Contract
Some tips for your application 🫡
Understand the Role: Before applying, make sure you fully understand the responsibilities of a Global Labeling Strategist. Familiarise yourself with key terms like CCDS, USPI, and SmPC, as well as the regulatory landscape in major markets.
Tailor Your CV: Highlight your relevant experience in regulatory labeling and project management. Make sure to include specific examples of your work with CCDS, SmPC, and USPI, as well as any cross-functional collaboration you've been involved in.
Craft a Compelling Cover Letter: Use your cover letter to explain why you're the perfect fit for this role. Discuss your understanding of global regulatory procedures and how your skills can help shape and manage global labeling strategies.
Proofread Your Application: Ensure that your CV and cover letter are free from errors. Attention to detail is crucial in regulatory affairs, so take the time to review your documents carefully before submitting your application.
How to prepare for a job interview at AL Solutions
✨Understand Global Labeling Regulations
Make sure you have a solid grasp of the global regulatory procedures, especially those related to CCDS, USPI, and SmPC. Familiarise yourself with the specific requirements for major markets like the US and EU, as this knowledge will be crucial during your interview.
✨Showcase Project Management Skills
Be prepared to discuss your experience in managing cross-functional teams and coordinating end-to-end labeling activities. Highlight specific projects where you successfully led a team or managed timelines, as this will demonstrate your ability to handle the responsibilities of the role.
✨Communicate Clearly and Effectively
Since excellent verbal and written communication skills are essential for this position, practice articulating your thoughts clearly. Be ready to explain complex regulatory concepts in simple terms, as you may need to collaborate with various stakeholders who might not have a regulatory background.
✨Prepare for Scenario-Based Questions
Anticipate questions that ask how you would handle specific regulatory challenges or health authority inquiries. Think of examples from your past experience where you successfully navigated similar situations, as this will showcase your problem-solving abilities and strategic thinking.