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- Tasks: Support global labelling teams and ensure regulatory compliance across multiple regions.
- Company: Join a dynamic team in a leading pharmaceutical company with a collaborative culture.
- Benefits: Flexible work options, competitive salary, and opportunities for professional growth.
- Why this job: Make a real impact on product labelling and regulatory processes in a global context.
- Qualifications: University degree in a scientific field and some regulatory experience required.
- Other info: Exciting opportunity to work in a fast-paced environment with diverse teams.
The predicted salary is between 36000 - 60000 £ per year.
When our values align, there's no limit to what we can achieve. We are seeking a dedicated Regulatory Affairs Labelling professional to join our growing team! This role offers an opportunity to work with global labelling teams, ensuring regulatory compliance and supporting product labelling management across multiple regions. The role can be home or office based in various European locations.
Role Responsibilities:
- Support Global Labelling, Regulatory (Clinical/Safety), or Medical Writing teams for labelling updates
- Manage Company Core Datasheet (CCDS) implementation into labelling and artworks
- Identify triggers for CCDS updates and coordinate impact assessments for technical changes
- Apply knowledge of Safety Signal Management and its impact on labelling
- Navigate CCDS governance processes in pharmaceutical environments
- Understand Periodic Safety Update Reports (PSUR) and their potential impact on labelling
- Manage the relationship between labelling and artwork processes
- Implement regulatory processes required to update product labelling (various variation categories)
- Prepare Addendum to Clinical Overview (Module 2.5) to support labelling variations
- Apply regulatory requirements for labelling updates across different regions (EU, EAEU, US, APAC)
- Manage SmPC, PIL and QRD requirements, EU linguistic reviews, and translation activities
- Coordinate readability and PIL testing processes
- Review and approve consumer-facing materials in accordance with approved labelling
- Participate in promotion review committees and provide regulatory guidance for local markets
- Provide technical and business consulting services within area of expertise
- Complete activities within project scope, timeline, and objectives
Skills and Experience required for the role:
- University Degree in a Scientific or Technical Discipline
- Initial years of labelling/regulatory experience with global responsibilities
- Regulatory Operations (Submission management) experience
- Outstanding interpersonal and intercultural communication skills (written and verbal)
- Critical thinking and problem-solving abilities
- Fluent in English, written and spoken
Regulatory Affairs Professional - Labelling (home or office based) in London employer: Parexel
Contact Detail:
Parexel Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Regulatory Affairs Professional - Labelling (home or office based) in London
✨Tip Number 1
Network like a pro! Reach out to professionals in the regulatory affairs field on LinkedIn or at industry events. We can’t stress enough how valuable personal connections can be in landing that dream job.
✨Tip Number 2
Prepare for interviews by brushing up on your knowledge of labelling regulations and compliance processes. We recommend practising common interview questions with a friend to boost your confidence and articulate your expertise.
✨Tip Number 3
Showcase your skills through real-life examples during interviews. We all love a good story, so share specific instances where you’ve successfully managed labelling updates or navigated regulatory challenges.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets noticed. Plus, we’re always on the lookout for passionate individuals who align with our values.
We think you need these skills to ace Regulatory Affairs Professional - Labelling (home or office based) in London
Some tips for your application 🫡
Show Your Passion for Regulatory Affairs: When you write your application, let your enthusiasm for regulatory affairs shine through! We want to see how your experience aligns with our mission and values. Share specific examples of your past work in labelling or regulatory roles to make your application stand out.
Tailor Your CV and Cover Letter: Don’t just send a generic CV! We love it when candidates tailor their applications to the role. Highlight your relevant skills and experiences that match the job description, especially those related to CCDS updates and safety signal management.
Be Clear and Concise: Keep your writing clear and to the point. We appreciate well-structured applications that are easy to read. Use bullet points where necessary and avoid jargon unless it’s relevant to the role. Remember, clarity is key!
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’re considered for the role. Plus, it shows you’re keen on joining our team at StudySmarter!
How to prepare for a job interview at Parexel
✨Know Your Regulatory Stuff
Make sure you brush up on your knowledge of regulatory affairs, especially around labelling. Familiarise yourself with terms like CCDS, PSUR, and SmPC. Being able to discuss these confidently will show that you’re serious about the role.
✨Showcase Your Communication Skills
Since this role requires outstanding interpersonal skills, prepare examples of how you've effectively communicated in past roles. Think about times when you navigated complex information or worked with diverse teams – these stories will highlight your fit for the job.
✨Understand the Global Landscape
This position involves working across various regions, so it’s crucial to understand the regulatory differences in labelling. Do some research on EU, EAEU, US, and APAC regulations. Being able to discuss these will demonstrate your readiness to tackle the global challenges of the role.
✨Prepare for Scenario Questions
Expect questions that assess your problem-solving abilities. Prepare for scenarios where you might need to manage labelling updates or navigate governance processes. Practising your responses will help you think on your feet during the interview.
