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For Companies At a Glance
- Tasks: Support global regulatory teams and manage product lifecycle compliance.
- Company: Join a dynamic team in a leading regulatory affairs organisation.
- Benefits: Flexible work options, competitive salary, and opportunities for professional growth.
- Why this job: Make a real impact on health compliance while working with diverse teams.
- Qualifications: Degree in a scientific field and experience in regulatory roles.
- Other info: Work from home or office in various European locations.
The predicted salary is between 36000 - 60000 £ per year.
We are seeking a dedicated Regulatory Affairs Professional to join our growing team. This role offers an opportunity to work with global and local regulatory teams, supporting product lifecycle management and ensuring compliance with health authority requirements. The role can be home or office based in various European locations.
Role Responsibilities
- Support global and/or local regulatory teams with comprehensive understanding of regional and global regulatory requirements
- Manage post-authorization lifecycle maintenance procedures (variations, renewals, PSURs) for multiple licenses
- Coordinate health authority interactions and responses to questions
- Prepare and organize local-specific documentation (Module 1) to meet national submission requirements
- Maintain up-to-date local national systems according to local legislation
- Manage impact assessments for technical changes affecting marketing authorizations
- Stay current on regulatory requirements and guidelines to ensure compliance
- Support health authority inspections as needed
- 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
- A few years of experience in an industry-related environment
- Experience in regulatory authority-facing roles
- Regulatory Operations (Submission management) experience
- Experience using Veeva Vault RIMS - strong plus
- Outstanding interpersonal and intercultural communication skills (written and verbal)
- Critical thinking and problem-solving abilities
- Fluent in English, written and spoken
Regulatory Affairs Generalist (home or office based) employer: Parexel International
Contact Detail:
Parexel International Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Regulatory Affairs Generalist (home or office based)
✨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 local and global regulatory requirements. We recommend creating a cheat sheet of key points to discuss, so you can impress your interviewers with your expertise.
✨Tip Number 3
Showcase your experience with Veeva Vault RIMS during interviews. If you’ve got it, flaunt it! We know that having hands-on experience with this tool can set you apart from other candidates.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets seen by the right people. Plus, we love seeing candidates who are proactive about their job search.
We think you need these skills to ace Regulatory Affairs Generalist (home or office based)
Some tips for your application 🫡
Tailor Your CV: Make sure your CV is tailored to the Regulatory Affairs role. Highlight your relevant experience, especially in regulatory authority-facing roles and any specific projects you've managed that align with the job description.
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 skills can contribute to our team. Be sure to mention your experience with Veeva Vault RIMS if you have it!
Showcase Your Communication Skills: Since outstanding communication is key in this role, make sure your written application reflects your ability to convey complex information clearly. Use concise language and check for any typos or grammatical errors before submitting.
Apply Through Our Website: We encourage you to apply through our website for a smoother process. It helps us keep track of your application and ensures you don’t miss out on any important updates from us!
How to prepare for a job interview at Parexel International
✨Know Your Regulations
Make sure you brush up on the latest regional and global regulatory requirements. Familiarise yourself with the specific regulations that apply to the role, as this will show your dedication and understanding of the industry.
✨Prepare for Technical Questions
Expect questions about post-authorization lifecycle maintenance and submission management. Be ready to discuss your experience with variations, renewals, and how you've handled health authority interactions in the past.
✨Showcase Your Communication Skills
Since this role requires outstanding interpersonal skills, practice articulating your thoughts clearly. Think of examples where you've successfully communicated complex information to diverse audiences, especially in a regulatory context.
✨Demonstrate Problem-Solving Abilities
Be prepared to discuss scenarios where you've had to think critically and solve problems related to regulatory compliance. Highlight your approach to managing technical changes and how you ensure adherence to local legislation.
