At a Glance
- Tasks: Manage regulatory projects and liaise with health authorities in the oncology sector.
- Company: Join a top 10 pharmaceutical company based in Berkshire, making a real impact.
- Benefits: Enjoy a competitive salary, annual bonus, and a comprehensive benefits package.
- Why this job: Be part of a dynamic team that influences healthcare and compliance in oncology.
- Qualifications: Life Sciences degree or equivalent experience; regulatory affairs background required.
- Other info: Contact Freddie Hill at Freddie.hill@pharma-partners.co.uk for more details.
The predicted salary is between 43200 - 72000 £ per year.
Job title: Regulatory Affairs Project Manager – UK/IE A Top 10 Pharmaceutical business in Berkshire are seeking a Regulatory Affairs Project Manager. This is a UK/IE affiliate role and will work across an Oncology portfolio. Responsibilities: Serves as Health Authority liaison and interfaces with Health Authorities. Lifecycle management of applicable products and management of Clinical Trial activities with the MHRA. Reviews promotional, non-promotional and training materials, as applicable, and ensure the materials are compliant with local regulations and internal policies and procedures. Ensures submission and content of new Marketing Authorisations, variations and other regulatory submissions, including label, artwork and local prescribing information are made in accordance with appropriate timings and requirements and maintain an appropriate tracking of the process as applicable. Requirements: Life Sciences Degree or equivalent experience Varied experience within Regulatory Affairs, including commercial affiliate awareness and clinical trial knowledge Experience of reviewing material against the ABPI Code of Practice Therapy experience within Oncology would be desirable Salary and benefits: A competitive salary, annual bonus and further benefits package is on offer. To apply for this position or hear further details then please contact Freddie Hill via Freddie.hill@pharma-partners.co.uk
Regulatory Affairs Project Manager employer: Pharma Partners Recruitment Ltd
Contact Detail:
Pharma Partners Recruitment Ltd Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Regulatory Affairs Project Manager
✨Tip Number 1
Familiarize yourself with the specific regulations and guidelines set by the MHRA, as this will be crucial in your role. Understanding the nuances of the UK regulatory landscape will help you stand out during discussions.
✨Tip Number 2
Network with professionals in the Regulatory Affairs field, especially those who have experience in Oncology. Engaging with industry peers can provide valuable insights and potentially lead to referrals.
✨Tip Number 3
Stay updated on recent changes in the ABPI Code of Practice and how they impact promotional materials. Demonstrating your knowledge of compliance will show your commitment to regulatory excellence.
✨Tip Number 4
Prepare to discuss your experience with lifecycle management and clinical trial activities in detail. Be ready to share specific examples that highlight your ability to manage regulatory submissions effectively.
We think you need these skills to ace Regulatory Affairs Project Manager
Some tips for your application 🫡
Understand the Role: Make sure to thoroughly read the job description for the Regulatory Affairs Project Manager position. Understand the key responsibilities and requirements, especially those related to Health Authority liaison and lifecycle management.
Tailor Your CV: Customize your CV to highlight relevant experience in Regulatory Affairs, particularly in Oncology and clinical trials. Emphasize any experience you have with the MHRA and compliance with local regulations.
Craft a Strong Cover Letter: Write a compelling cover letter that showcases your passion for Regulatory Affairs and your understanding of the pharmaceutical industry. Mention specific experiences that align with the responsibilities outlined in the job description.
Proofread Your Application: Before submitting your application, carefully proofread all documents for spelling and grammatical errors. Ensure that your application is professional and polished, reflecting your attention to detail.
How to prepare for a job interview at Pharma Partners Recruitment Ltd
✨Know Your Regulatory Landscape
Familiarize yourself with the UK and IE regulatory frameworks, especially those related to oncology. Being able to discuss specific regulations and how they impact product lifecycle management will show your expertise.
✨Demonstrate Your Communication Skills
As a liaison with Health Authorities, effective communication is key. Prepare examples of how you've successfully navigated complex discussions or negotiations in previous roles.
✨Showcase Your Experience with Clinical Trials
Be ready to discuss your experience managing clinical trial activities, particularly with the MHRA. Highlight any specific projects where you ensured compliance and met submission deadlines.
✨Prepare for Compliance Questions
Expect questions about reviewing promotional materials against the ABPI Code of Practice. Have examples ready that demonstrate your attention to detail and understanding of compliance requirements.