Regulatory Affairs Generalist (home or office based) in London
Regulatory Affairs Generalist (home or office based)

Regulatory Affairs Generalist (home or office based) in London

London Full-Time 36000 - 60000 £ / year (est.) No home office possible
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At a Glance

  • Tasks: Support global regulatory teams and manage product lifecycle compliance.
  • Company: Join a growing team in a dynamic regulatory affairs environment.
  • Benefits: Flexible work options, competitive salary, and opportunities for professional growth.
  • Why this job: Make a real impact on health authority compliance and product success.
  • Qualifications: University degree in a scientific field and experience in regulatory roles.
  • Other info: Work in a collaborative atmosphere with diverse teams across Europe.

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) in London employer: Parexel International

Join a dynamic and innovative team that values your expertise in regulatory affairs, offering a flexible work environment either from home or in one of our European offices. We pride ourselves on fostering a collaborative culture that encourages professional growth and development, providing you with the tools and support needed to excel in your career while making a meaningful impact in the healthcare sector.
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Contact Detail:

Parexel International Recruiting Team

StudySmarter Expert Advice 🤫

We think this is how you could land Regulatory Affairs Generalist (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 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 hands-on experience, make sure to highlight it! We want to see how you can bring that knowledge to our team.

✨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 take the initiative to connect directly with us.

We think you need these skills to ace Regulatory Affairs Generalist (home or office based) in London

Regulatory Affairs Knowledge
Post-Authorization Lifecycle Management
Health Authority Interaction
Documentation Preparation
Regulatory Compliance
Impact Assessment Management
Technical Change Management
Veeva Vault RIMS
Interpersonal Communication Skills
Intercultural Communication Skills
Critical Thinking
Problem-Solving Abilities
Project Management
Fluency in English

Some tips for your application 🫡

Tailor Your CV: Make sure your CV is tailored to the Regulatory Affairs role. Highlight your experience with regulatory requirements and any relevant projects you've worked on. We want to see how your background aligns with what we do!

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 benefit our team. Keep it concise but engaging – we love a good story!

Showcase Your Communication Skills: Since this role involves a lot of interaction with health authorities, make sure to demonstrate your outstanding communication skills in your application. Use clear and professional language, and don’t forget to proofread for any errors!

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’s super easy – just follow the prompts!

How to prepare for a job interview at Parexel International

✨Know Your Regulations

Make sure you brush up on both 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 outstanding interpersonal skills are crucial, practice articulating your thoughts clearly. You might be asked to explain complex regulatory concepts, so being able to communicate effectively is key.

✨Demonstrate Problem-Solving Abilities

Be prepared to share examples of how you've tackled challenges in previous roles. Highlight your critical thinking skills and how you've managed technical changes affecting marketing authorisations.

Regulatory Affairs Generalist (home or office based) in London
Parexel International
Location: London

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