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- Tasks: Support regulatory strategies and manage submissions for medicinal drug products.
- Company: Exciting global pharmaceutical company with a hybrid work model.
- Benefits: Competitive PAYE rate, flexible working options, and potential for contract extension.
- Why this job: Join a dynamic team and make a real impact in regulatory affairs.
- Qualifications: Bachelor's degree in a relevant field and experience with UK and Ireland drug regulations.
- Other info: 12-month contract with excellent career growth opportunities.
The predicted salary is between 48000 - 72000 £ per year.
This is a great opportunity for a Regulatory Affairs (RA) Specialist to develop your career in regulatory affairs for drug products. Do you have experience in product labelling activities and regulatory drug submissions? Do you have experience of Windsor Framework compliance? Have you compiled regulatory documents for submissions within the UK and Ireland? Looking for a contract role with an exciting global pharmaceutical company? If yes then this is the role for you.
Responsibilities
- Support regulatory strategies for assigned product portfolios and perform life cycle management submissions for medicinal drug products.
- Manage local Regulatory Affairs activities and help support business product launches and tender applications mainly for the UK and Irish markets.
- Support and maintain pharmaceutical product portfolios.
- Manage ongoing product information updates for Windsor Framework compliance.
- Support regulatory project plan execution.
- Assist in preparation and review of labelling and local SOPs.
- Maintain awareness of regulatory requirements relating to UKI regulations.
- Compile regulatory documents for submission.
- Maintain internal product information databases (e.g. RIM Vault) and change controls.
Contract Details
This is a 12 months contract role which will be reviewed for a possible extension or go permanent; this depends on the individual and business performance. The role is based on a hybrid pattern (home 3 days a week, office 2 days a week in Newbury, Berkshire) with the option to be on site every day. The client will also be flexible with 5 days a week working from home. PAYE rate: £30.50.
Skills and Qualifications
- Bachelor's degree or equivalent in a relevant scientific discipline with experience of UK and Ireland drugs regulatory labelling requirements, Regulatory Authority submissions and Regulatory Authority communication/negotiation.
- Excellent project management skills.
- Computer skills (Word, Excel, PowerPoint, Outlook, corporate software).
- Good project management experience.
How to Apply
To apply for this opportunity, please send a Word copy of your CV to me now by clicking on the Apply button or call me for a confidential chat. Please ensure you have read and agree to our Privacy Policy which can be found on the Quality Start website.
Additional Information
If this sounds like the role for you or a colleague then please contact us. If we successfully fill a permanent placement from your referral, we will send you a cheque of £300. We also have incentive schemes for referring contractors/temp staff; please contact us for details. For a list of our current vacancies, please visit the Quality Start website. If you do not hear from Quality Start within 2 weeks, your CV has not been shortlisted for this role. Quality Start are acting as a specialist recruitment consultancy for this role.
Senior Regulatory Affairs Associate in London employer: Quality Start
Contact Detail:
Quality Start Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Senior Regulatory Affairs Associate in London
✨Tip Number 1
Network like a pro! Reach out to your connections in the pharmaceutical industry, especially those in regulatory affairs. A friendly chat can lead to insider info about job openings or even a referral.
✨Tip Number 2
Prepare for interviews by brushing up on your knowledge of UK and Ireland drug regulations. Be ready to discuss your experience with product labelling and submissions, as these are hot topics for the role.
✨Tip Number 3
Showcase your project management skills! Be prepared to share examples of how you've successfully managed regulatory projects in the past. This will demonstrate your capability to handle the responsibilities of the role.
✨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 take the initiative to connect directly with us.
We think you need these skills to ace Senior Regulatory Affairs Associate in London
Some tips for your application 🫡
Tailor Your CV: Make sure your CV is tailored to the Senior Regulatory Affairs Associate role. Highlight your experience with product labelling and regulatory submissions, especially in the UK and Ireland. We want to see how your skills match what we're looking for!
Showcase Relevant Experience: When writing your application, focus on your past experiences that relate directly to the responsibilities listed in the job description. If you've managed local Regulatory Affairs activities or supported product launches, let us know!
Keep It Professional Yet Personal: While we appreciate a professional tone, don’t be afraid to let your personality shine through. Share your passion for regulatory affairs and why you’re excited about this opportunity with us at StudySmarter.
Apply Through Our Website: We encourage you to apply through our website for a smoother process. It helps us keep track of applications and ensures you get all the updates directly from us. Plus, it’s super easy!
How to prepare for a job interview at Quality Start
✨Know Your Regulatory Stuff
Make sure you brush up on UK and Ireland drug regulatory requirements, especially around labelling and submissions. Being able to discuss specific regulations and how they apply to the role will show that you're not just familiar with the basics but are ready to hit the ground running.
✨Showcase Your Project Management Skills
Since project management is key for this role, prepare examples of past projects where you successfully managed timelines and deliverables. Be ready to explain your approach to keeping everything on track, especially in a regulatory context.
✨Familiarise Yourself with the Windsor Framework
Understanding the Windsor Framework compliance is crucial. Do some research and be prepared to discuss how it impacts regulatory affairs. This will demonstrate your proactive attitude and commitment to staying updated on industry changes.
✨Prepare Questions for Them
Interviews are a two-way street! Prepare thoughtful questions about their regulatory strategies and how they manage product launches. This shows your genuine interest in the role and helps you assess if the company is the right fit for you.
