At a Glance
- Tasks: Drive labelling strategy and ensure global alignment of product information.
- Company: Leading biotech firm focused on innovative therapeutic solutions.
- Benefits: Flexible work options, competitive salary, and opportunities for professional growth.
- Other info: Join a dynamic team and contribute to cutting-edge healthcare solutions.
- Why this job: Make a real impact in global regulatory affairs and shape product labelling strategies.
- Qualifications: 7+ years in biotech/pharma with strong regulatory and labelling experience.
The predicted salary is between 60000 - 80000 £ per year.
About the Role
As a Labelling Strategy Regulatory Affairs Consultant you will act as a labeling strategist within Global Regulatory Affairs (GRA). You will drive the maintenance of the Company Core Data Sheet (CCDS), the US Prescribing Information (USPI) and the EU Summary of Product Characteristics (SmPC) for product portfolio, as assigned, to ensure optimal alignment of the company position, labeling requirements, and commercial opportunities for a therapeutic area. You will ensure that the company core product claims across products with the same active substance are globally aligned and lead the Global Labeling Committee assessment of proposed changes to the CCDS, including management of the exception process between the CCDS and the USPI and EU SmPC. The role can be home or office based in various European locations.
Key Responsibilities
- Maintains the Company Core Data Sheet, the USPI and the EU SmPC as assigned.
- For the CCDS, leads the interactions with relevant Subject Matter Experts and stakeholders, such as Global Clinical Safety and Pharmacovigilance, Global Clinical Development, Global Regulatory Affairs and Commercial Development and Operations.
- For the USPI and EU SmPC, collaborates with the Regional Regulatory Therapeutic Area leads on the review of these labels and respective interaction with relevant SMEs.
- Ensures consistent communication to the Global Labeling Associates, regions and countries regarding updated CCDSs for assigned portfolio of products.
- Leads the assessment and, as necessary, Global Labeling Committee review of proposed exceptions between the CCDS and the USPI and/or SmPC utilizing established departmental processes and maintaining compliance.
- Escalates differences and compliance issues to the Director, Global Labeling Strategy and/or labeling governance bodies as necessary.
- Represents Global Labeling on respective product Global Regulatory Affairs Strategy Teams and ensures that an effective communication pathway exists between the Strategy Teams and Global Labeling.
- Remains up to date with the global labeling requirements and expectations.
- Represents Global Labeling in internal and external meetings as needed.
Skills And Experience Required For The Role
- University degree in Life Sciences or related Pharmaceutical field.
- Minimum of 7 years of biotech/pharmaceutical industry experience, including 4 years of labeling/regulatory experience combined with other global responsibility.
- Knowledge and understanding of principles of regulatory relevant to drug development, global labeling, and post-marketing requirements.
- Demonstrated problem-solving ability; able to analyze risk and make appropriate recommendations/decisions.
- Effective communication skills to a variety of audiences, specifically related to the explanation of complex concepts, options and impact.
- Attention to detail, coupled with the ability to think strategically.
- Fluency in English (verbal and written).
Regulatory Affairs Consultant - Labelling Strategy (home or office based) in Uxbridge employer: Parexel
As a leading player in the pharmaceutical industry, our company offers an exceptional work environment that fosters collaboration and innovation. With flexible working options available, including home or office-based roles across various European locations, we prioritise employee well-being and work-life balance. Our commitment to professional development ensures that you will have ample opportunities for growth and advancement within a supportive and dynamic team culture.
StudySmarter Expert Advice🤫
We think this is how you could land Regulatory Affairs Consultant - Labelling Strategy (home or office based) in Uxbridge
✨Network Like a Pro
Get out there and connect with folks in the industry! Attend conferences, webinars, or local meetups related to regulatory affairs. You never know who might have the inside scoop on job openings or can put in a good word for you.
✨Show Off Your Expertise
When you get the chance to chat with potential employers, don’t hold back on showcasing your knowledge of labelling strategy and regulatory affairs. Share your insights on current trends and challenges in the field to demonstrate your passion and expertise.
✨Tailor Your Approach
Every company is different, so make sure you tailor your conversations and networking efforts to align with their specific needs and values. Research the company’s products and regulatory strategies to show you’re genuinely interested in what they do.
✨Apply Through Our Website
Don’t forget to check out our website for the latest job openings! Applying directly through our site not only shows your interest but also helps us keep track of your application. Plus, it’s super easy to navigate!
We think you need these skills to ace Regulatory Affairs Consultant - Labelling Strategy (home or office based) in Uxbridge
Some tips for your application 🫡
Tailor Your CV:Make sure your CV is tailored to the role of Regulatory Affairs Consultant. Highlight your relevant experience in labelling strategy and regulatory affairs, and don’t forget to showcase your problem-solving skills and attention to detail!
Craft a Compelling Cover Letter:Your cover letter is your chance to shine! Use it to explain why you’re the perfect fit for this role. Mention specific experiences that align with the job description and show us your passion for the pharmaceutical industry.
Showcase Your Communication Skills:Since effective communication is key in this role, make sure your application reflects your ability to convey complex concepts clearly. Use straightforward language and structure your application logically to demonstrate your communication prowess.
Apply Through Our Website:We encourage you to apply through our website for a smoother process. It’s the best way for us to receive your application and ensures you don’t miss out on any important updates from our team!
How to prepare for a job interview at Parexel
✨Know Your Labels
Make sure you’re well-versed in the specifics of the Company Core Data Sheet (CCDS), US Prescribing Information (USPI), and EU Summary of Product Characteristics (SmPC). Brush up on recent changes in global labelling requirements and be ready to discuss how they impact the role.
✨Showcase Your Experience
With a minimum of 7 years in the biotech/pharmaceutical industry, highlight your relevant experience. Be prepared to share specific examples of how you've managed labelling strategies or navigated regulatory challenges in previous roles.
✨Communicate Clearly
Effective communication is key in this role. Practice explaining complex regulatory concepts in simple terms. You might be asked to demonstrate this skill during the interview, so think about how you can convey your ideas clearly and concisely.
✨Demonstrate Problem-Solving Skills
Prepare to discuss scenarios where you’ve had to analyse risks and make decisions. Think of examples that showcase your strategic thinking and attention to detail, as these are crucial for the role of a Labelling Strategy Regulatory Affairs Consultant.
