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- Tasks: Lead global labeling strategy and manage document updates for regulatory compliance.
- Company: Join Smartedge’s innovative team, driving impactful regulatory solutions remotely.
- Benefits: Enjoy remote work flexibility and the chance to collaborate with global experts.
- Why this job: Be part of a dynamic environment that values your input and fosters professional growth.
- Qualifications: Basic knowledge of regulatory labeling and experience in managing medium complex projects required.
- Other info: Connect with us for more details or to refer someone interested!
The predicted salary is between 36000 - 60000 £ per year.
Smartedge’s Client is looking for a Global Labeling Strategist (Regulatory Studio) @ Remote (UK).
Experience Required:
- Global Labeling Strategy has overall accountability for relevant updates to labeling documents (Company Core Data Sheet (CCDS), United States Package Inserts (USPI) and EU Summary of Product Characteristics (SmPC) for products registered via the Centralized, Mutual Recognition or Decentralized Procedure.
- Drives labeling strategy in partnership with the Global Regulatory Team Leader in line with the overall regulatory strategy by providing labeling expertise (labeling regulations, internal processes, and competitor analyses) for CCDS, USPI and SmPC (Centralized/Mutual Recognition/Decentralized Procedure) for medium to low complex projects in the Lifecycle Management (LCM) projects.
- Serves as primary contact for Labeling Strategy Team (LST).
- Works closely with TA counterparts in Global Regulatory Strategy, Worldwide Patient Safety (WWPS), Clinical Development and Medical with LST with management support.
- Serves as interface for Country Regulatory Managers to support timely and quality labeling submissions globally.
- Coordinates labeling activities of multifunctional contributors, reviewers and approvers and manages the label review and approval process to maximize speed and quality.
- Ensures effective planning of all cross-functional labeling activities.
- Supports responses to labeling related inquiries from Global Health Authorities and related to inspection activities.
- Reviews country labels to ensure labeling compliance.
- Basic knowledge of regulatory labeling and labeling processes.
- Has labeling expertise in at least one major region and CCDS.
- Has a basic knowledge of procedures, regulatory requirements and GxP.
- Good understanding of Drug Development and Commercialization of prescription medicines.
- Ability to understand regulatory implications of product strategy related to labeling development, assessment, and management.
- Ability to develop strong and positive working relationships across diverse teams and within a global environment.
- Ability to influence and lead a diverse group of Subject Matter Experts from a variety of disciplines and facilitate discussions and decision making.
- Experience in managing medium complex projects.
- Excellent verbal and written communication skills.
- Keen attention to detail and accuracy.
- Ability to assimilate clinical and scientific information and present it in a concise manner.
If this sounds like a role you would be interested in or if you know someone in this field, connect with me or email me.
Alternatively, you can call me on Tel: +44(0)203 500 2108.
Global Labeling Strategist (Regulatory Studio ) employer: Smartedge Solutions
Contact Detail:
Smartedge Solutions Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Global Labeling Strategist (Regulatory Studio )
✨Tip Number 1
Familiarise yourself with the latest global regulatory guidelines and labelling requirements. Understanding the nuances of CCDS, USPI, and SmPC will give you a significant edge in discussions and interviews.
✨Tip Number 2
Network with professionals in the regulatory field, especially those who have experience in labelling strategy. Engaging with industry experts can provide insights and potentially lead to referrals.
✨Tip Number 3
Prepare to discuss specific examples of how you've managed labelling projects or collaborated with cross-functional teams. Highlighting your experience in influencing diverse groups will demonstrate your capability for this role.
✨Tip Number 4
Stay updated on recent trends in drug development and commercialisation. Being knowledgeable about current market dynamics will help you articulate your understanding of the regulatory implications during the interview.
We think you need these skills to ace Global Labeling Strategist (Regulatory Studio )
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 key terms like CCDS, USPI, and SmPC, as well as the regulatory processes involved.
Tailor Your CV: Highlight your relevant experience in regulatory labeling and project management. Make sure to include specific examples of your work with labeling documents and any experience you have with cross-functional teams.
Craft a Compelling Cover Letter: In your cover letter, express your passion for regulatory strategy and your understanding of the role. Mention how your skills align with the job requirements and provide examples of how you've successfully managed similar projects in the past.
Proofread Your Application: Ensure that your CV and cover letter are free from errors. Pay attention to detail, as this role requires keen accuracy. Consider asking a friend or colleague to review your application before submission.
How to prepare for a job interview at Smartedge Solutions
✨Understand the Regulatory Landscape
Familiarise yourself with the latest regulations and guidelines related to global labelling, especially for CCDS, USPI, and SmPC. Being able to discuss recent changes or trends in regulatory requirements will demonstrate your expertise and commitment to the role.
✨Showcase Your Project Management Skills
Prepare examples of how you've successfully managed medium complex projects in the past. Highlight your ability to coordinate cross-functional teams and ensure timely submissions, as this is crucial for the Global Labeling Strategist position.
✨Communicate Clearly and Effectively
Since excellent verbal and written communication skills are essential, practice articulating your thoughts clearly. Be ready to present complex information concisely, as you may need to explain labelling strategies to diverse teams.
✨Build Rapport with Interviewers
Demonstrate your ability to develop strong working relationships by engaging with your interviewers. Ask insightful questions about their experiences and the company culture, showing that you value collaboration and teamwork in a global environment.
