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- Tasks: Support regulatory strategies and manage product submissions for medicinal drug products.
- Company: Exciting global pharmaceutical company with a focus on innovation.
- Benefits: Flexible working options, competitive PAYE rate, and potential for contract extension.
- Why this job: Join a dynamic team and make a real impact in the pharmaceutical industry.
- Qualifications: Bachelor’s degree in a relevant field and experience in UK/Ireland drug regulations.
- Other info: Work from home 3 days a week with excellent career growth opportunities.
The predicted salary is between 42000 - 60000 £ 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 the 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.
Your role as a Pharmaceuticals Regulatory Affairs Associate will involve supporting regulatory strategies for assigned product portfolios and performing life cycle management submissions for medicinal drug products. You will manage local Regulatory Affairs activities and help support business product launches and tender applications mainly for the UK and Irish markets.
Duties and responsibilities include:
- Supporting and maintaining pharmaceutical product portfolios.
- Managing ongoing product information updates for Windsor Framework compliance.
- Supporting regulatory project plan execution.
- Assisting in preparation and review of labelling and local SOPs.
- Maintaining awareness of regulatory requirements relating to UKI regulations.
- Compiling regulatory documents for submission.
- Maintaining internal product information databases (e.g. RIM Vault) and change controls.
This is a 12 months contract role which will be reviewed for a possible extension or go permanent however this is all dependent on the individual and business performance. This is a role based working from home 3 days a week and to attend the office 2 days a week which is located in Newbury, Berkshire. There is also the option to be on site every day. The client will also be flexible with 5 days a week working from home.
The PAYE rate is £30.50.
To apply for the role of Pharmaceutical Regulatory Affairs Associate you will have the following:
- 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, Power Point, Outlook, corporate software).
- Good project management experience.
To apply for this one off 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.
If this sounds like the role for you or a colleague then please don’t hesitate to contact us.
If we manage to successfully fill a permanent placement from your recommendation then we will send you a cheque of £300. We also have many incentive schemes for referring contractors/temp staff so please contact us with the referral and we can provide you with more information.
If you do not hear from Quality Start within 2 weeks your CV has not been short listed for this role.
Quality Start are acting as a specialist recruitment consultancy for this role.
Senior Regulatory Affairs Associate in Reading 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 Reading
✨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 referrals.
✨Tip Number 2
Prepare for interviews by brushing up on your knowledge of UK and Ireland drug regulations. We want you to be able to discuss your experience with product labelling and submissions confidently!
✨Tip Number 3
Showcase your project management skills during interviews. Be ready to share examples of how you've successfully managed regulatory projects in the past. This will help us see how you can contribute to our team.
✨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 that extra step to connect with us directly.
We think you need these skills to ace Senior Regulatory Affairs Associate in Reading
Some tips for your application 🫡
Tailor Your CV: Make sure your CV is tailored to the role of Senior Regulatory Affairs Associate. 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, emphasise any previous roles where you've managed regulatory affairs or worked on compliance with frameworks like the Windsor Framework. This will help us see that you have the right background for the job.
Be Clear and Concise: Keep your application clear and to the point. Use bullet points to outline your key achievements and responsibilities in past roles. We appreciate straightforward communication, so make it easy for us to see your qualifications!
Apply Through Our Website: Don't forget to apply through our website! It’s the best way for us to receive your application and ensures you’re considered for this exciting opportunity. We can’t wait to hear from you!
How to prepare for a job interview at Quality Start
✨Know Your Regulatory Stuff
Make sure you brush up on your knowledge of UK and Ireland drug regulatory requirements. Be ready to discuss your experience with product labelling activities and regulatory submissions, especially in relation to the Windsor Framework compliance.
✨Showcase Your Project Management Skills
Since excellent project management skills are crucial for this role, prepare examples of how you've successfully managed projects in the past. Highlight any specific tools or methodologies you used to keep everything on track.
✨Familiarise Yourself with the Company
Research the global pharmaceutical company you're interviewing with. Understand their product portfolio and recent news. This will help you tailor your answers and show genuine interest in their operations.
✨Prepare Questions
Have a few thoughtful questions ready to ask at the end of the interview. This could be about their regulatory strategies or how they handle compliance challenges. It shows you're engaged and serious about the role.
