At a Glance
- Tasks: Lead the creation and updates of regulatory labelling documents for innovative treatments.
- Company: Join Wipro, a renowned biopharmaceutical company making a difference in rare diseases.
- Benefits: Enjoy a competitive salary, flexible remote work, and diverse training opportunities.
- Other info: Experience career growth in a dynamic, multinational environment.
- Why this job: Make a meaningful impact in the rare disease community while collaborating with healthcare professionals.
- Qualifications: 4-6 years in Pharma or Medical Devices with strong regulatory affairs experience.
The predicted salary is between 36000 - 60000 £ per year.
The Regulatory Labelling Lead role is part of a project with a leading biopharmaceutical company focused on developing innovative treatments for rare and ultra-rare genetic diseases. If you are passionate about working with a renowned organization committed to advancing research and supporting patients and families affected by these conditions, we encourage you to apply. This position offers the opportunity to collaborate with healthcare professionals, researchers, and advocacy groups, making a meaningful impact in the rare disease community. The role is fully remote and can be performed from anywhere in Europe. Join us and be part of our inspiring journey of growth!
Responsibilities:
- Has overall accountability for the initial creation and relevant updates to labeling documents.
- Guiding the labeling team to develop and maintain Core Data sheets, USPI, SmPC and associated Patient Labeling documents along with regulatory authority driven documents such as Core Safety Profile.
- The lead needs to be updated with labeling guidelines and regulations pertaining to the development/maintenance of US and EU labeling.
- Should be knowledgeable on key labeling requirements worldwide, in order to ensure that CDS updates may be implemented globally. The lead will review the downstream impact of CDS updates on Local Product Documents (LPDs) and ensure that downstream impact on LPDs is considered during Labeling Team discussions.
- Provides project management to the Labeling team throughout the entire process, from the decision making to updates in CDS/USPI/SPC.
- Act as a reviewer and signatory during review of labeling ensuring that content complies with regulatory requirements.
- Facilitate cross-functional and team awareness and understanding of regulatory issues as appropriate.
- Contribute to local or global system and process improvements.
Requirements:
- 4-6 years of experience in the Pharma or Medical Devices industry.
- Significant hands-on registration experience associated with development, maintenance, and commercialization activities within Regulatory affairs.
- Understand regulatory implications of product strategy with regards to the product label & assessment.
- Ability to interpret and apply global and local regulatory guidance around labeling and associated supportive documentation.
- Excellent written and verbal communication skills.
- Proven strength in logical, analytical and writing ability.
- Demonstrate project management skills and attention to detail.
Good to have skills:
- Proven understanding of the dynamics and purpose of CDS; experiences of review and implications of CDS.
- Prior experience with biologicals.
Opportunity to work in a fast-growing company and in a multinational environment for some of the biggest brands in the world. Potential for career growth within the organization and the opportunity to build a successful career path. Flexible and fully remote work environment, allowing you to work from the comfort of your home in any city in Europe. Access to a diverse range of benefits. Personal and professional development through a variety of training programs covering both hard and soft skills. Comprehensive salary package with various components. Complex reward and recognition schemes (both non-monetary and monetary options).
Regulatory Labelling Lead employer: Wipro
Wipro is an exceptional employer, offering a dynamic work environment in the heart of London where innovation meets collaboration. With a strong focus on employee growth, we provide extensive training and development opportunities, ensuring our team members thrive in their careers while working on impactful projects across diverse sectors. Our competitive salary and benefits package, combined with a culture that values creativity and excellence, make Wipro a rewarding place to advance your professional journey.
StudySmarter Expert Advice🤫
We think this is how you could land Regulatory Labelling Lead
✨Tip Number 1
Don't just sit back and wait for the job to come to you! Reach out directly to the job poster on LinkedIn. A quick message can make a huge difference and show your enthusiasm for the role.
✨Tip Number 2
Network like a pro! Connect with professionals in the biopharmaceutical field, join relevant groups, and engage in discussions. You never know who might have insider info or a referral that could land you an interview.
✨Tip Number 3
Prepare for virtual interviews by setting up a professional space at home. Make sure your tech is working, and practice answering common questions related to regulatory affairs. Confidence is key!
✨Tip Number 4
Apply through our website! It’s the best way to ensure your application gets noticed. Plus, it shows you're serious about joining our team and making an impact in the rare disease community.
We think you need these skills to ace Regulatory Labelling Lead
Some tips for your application 🫡
Tailor Your Application:Make sure to customise your CV and cover letter for the Regulatory Labelling Lead role. Highlight your relevant experience in regulatory affairs and any specific projects that align with the job description. We want to see how you fit into our mission!
Showcase Your Skills:Don’t just list your skills; demonstrate them! Use examples from your past work to show how you've successfully managed labelling documents or navigated regulatory guidelines. This is your chance to shine, so let us see your strengths!
Be Clear and Concise:When writing your application, keep it clear and to the point. Avoid jargon unless it's necessary, and make sure your key achievements stand out. We appreciate straightforward communication, especially in a role that requires excellent written skills!
Apply Through Our Website:We encourage you to apply directly through our website. It’s the best way to ensure your application gets to the right people. Plus, it shows us you’re serious about joining our inspiring journey at Wipro!
How to prepare for a job interview at Wipro
✨Know Your Labelling Guidelines
Make sure you brush up on the latest labelling guidelines and regulations, especially those relevant to the US and EU. Being able to discuss these confidently will show that you're not just familiar with the basics but are also proactive in staying updated.
✨Showcase Your Project Management Skills
Prepare examples from your past experiences where you've successfully managed projects, particularly in regulatory affairs. Highlight how you guided teams through complex processes and ensured compliance with regulatory requirements.
✨Communicate Clearly and Effectively
Since excellent communication skills are a must for this role, practice articulating your thoughts clearly. You might want to prepare a few key points about your experience with labelling documents and how you’ve facilitated cross-functional discussions.
✨Demonstrate Your Passion for Rare Diseases
Express your enthusiasm for working in the biopharmaceutical sector, especially in relation to rare and ultra-rare genetic diseases. Share any personal connections or motivations that drive your interest in this field, as it can resonate well with the interviewers.
