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For Companies At a Glance
- Tasks: Manage EU product information and lead labelling processes for regulatory compliance.
- Company: Join a leading company in the life sciences sector with a collaborative culture.
- Benefits: Flexible working options, competitive salary, and opportunities for professional growth.
- Why this job: Make a real impact on product labelling and work with cross-functional teams.
- Qualifications: Degree in life sciences and strong knowledge of EU regulatory requirements.
- Other info: Dynamic role with excellent career advancement opportunities.
The predicted salary is between 36000 - 60000 £ per year.
When our values align, there's no limit to what we can achieve.
About the Role
We are seeking an experienced Regulatory Affairs professional to join our team as a European Labelling & Promotional Regulatory Specialist. This key position provides expert guidance across a Therapeutic business unit, delivering both strategic and operational regulatory input to cross-functional teams. The role can be home or office based in various European locations.
Key Responsibilities
- EU Product Information Management: Create, update and maintain EU Product Information in line with CCDS, Agency RTQ, and current labelling requirements.
- Serve as the key point of contact for EU Product Information for both internal and external stakeholders.
- Lead reviews, round tables, and approvals for EU Product Information in appropriate systems according to SOPs.
- Deliver competitive labelling searches and contribute to TLP for early development assets.
- Operational Excellence: Ensure timely tracking and management of all EU Product Information in appropriate systems.
- Lead Readability Testing processes including vendor selection, agreement management, questionnaire review, and submission of final reports.
- Coordinate Linguistic Review processes with LR Coordinator according to SOPs.
- Communicate proactively with the Artworks team for artwork and mock-up changes, participating in Change Control Processes.
- Leadership & Collaboration: Lead the Local Labelling Committee for creation, review and approval of EU Product Information.
- Serve on the EU Clearance Committee as primary regulatory reviewer for promotional materials.
- Build strong relationships with EU and Global Regulatory teams, local business partners.
- Monitor changes in EMA labelling requirements and keep the organization informed of technology requirements.
Qualifications & Skills required for the role:
- University degree in a life science discipline.
- Strong knowledge of EU regulatory requirements for product labelling and promotional materials.
- Experience with electronic content management systems and regulatory SOPs.
- Excellent project management and organizational abilities.
- Outstanding written and verbal communication skills.
- Proven ability to work effectively in cross-functional teams.
- Fluent in English, written and spoken.
Senior Regulatory Affairs Consultant - Labelling (home or office based) in Harrow employer: Parexel
Contact Detail:
Parexel Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Senior Regulatory Affairs Consultant - Labelling (home or office based) in Harrow
✨Tip Number 1
Network like a pro! Reach out to your connections in the regulatory affairs field and let them know you're on the lookout for opportunities. You never know who might have the inside scoop on a role that’s perfect for you.
✨Tip Number 2
Prepare for interviews by brushing up on your knowledge of EU regulatory requirements. Be ready to discuss how your experience aligns with the key responsibilities of the role, especially around product information management and operational excellence.
✨Tip Number 3
Showcase your project management skills! During interviews, share specific examples of how you've successfully led cross-functional teams or managed complex projects in the past. This will demonstrate your ability to thrive in a collaborative environment.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets noticed. Plus, we love seeing candidates who are proactive about their job search!
We think you need these skills to ace Senior Regulatory Affairs Consultant - Labelling (home or office based) in Harrow
Some tips for your application 🫡
Tailor Your CV: Make sure your CV reflects the skills and experiences that align with the Senior Regulatory Affairs Consultant role. Highlight your knowledge of EU regulatory requirements and any relevant project management experience to catch our eye!
Craft a Compelling Cover Letter: Your cover letter is your chance to shine! Use it to explain why you’re passionate about regulatory affairs and how your background makes you a perfect fit for our team. Don’t forget to mention your experience with labelling and promotional materials.
Showcase Your Communication Skills: Since this role requires outstanding written and verbal communication, make sure your application is clear and concise. Use professional language but let your personality shine through – we want to get to know the real you!
Apply Through Our Website: We encourage you to apply directly through our website. 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. Plus, it shows you’re keen to join us!
How to prepare for a job interview at Parexel
✨Know Your Regulatory Stuff
Make sure you brush up on EU regulatory requirements for product labelling and promotional materials. Familiarise yourself with the latest changes in EMA labelling requirements, as this will show your commitment to staying updated in the field.
✨Showcase Your Project Management Skills
Prepare examples of how you've successfully managed projects in the past. Highlight your organisational abilities and how you've led cross-functional teams to achieve operational excellence. This is key for the role!
✨Communicate Like a Pro
Since outstanding communication skills are a must, practice articulating your thoughts clearly and concisely. Be ready to discuss how you've built strong relationships with stakeholders and collaborated effectively in previous roles.
✨Be Ready for Scenario Questions
Expect questions that assess your problem-solving skills and ability to handle real-life situations. Think about scenarios where you had to lead reviews or manage approvals, and be prepared to explain your thought process and outcomes.
